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European Association of Percutaneous Cardiovascular Interventions (EAPCI): EuroPCR 2013
Bioresorbable coronary scaffolds quickly snag European role
PARIS – Bioresorbable coronary stents programmed to disappear look like they are here to stay.
Late last year, interventional cardiology began its slow but inexorable shift from metallic coronary stents to bioresorbable scaffolds that disappear from arteries within a couple of years, and in newer models, within several months.
The first bioresorbable coronary stent, called a bioresorbable vascular scaffold (BVS), came out for routine use in Europe last September under the brand name Absorb. While the U.S. pivotal trial for this BVS launched only in January, as early as last September interventionalists at a few European centers felt so convinced by the BVS concept that they designated it their "default" device for percutaneous coronary interventions (PCI). While early European results from more than 200 patients treated with default BVS were generally encouraging, although not without a problem, default BVS currently operates with enough exclusions and caveats to warrant a big asterisk.
A major lesson from "default" use of BVS is that they are clearly not for everyone right now. The largest default bioresorbable program reported so far includes 176 BVS placed by PCI in 174 patients during September 2012 through April 2013 at the Thoraxcenter in Rotterdam. Those 176 interventions were out of 1,018 procedures done in 958 patients during the same 8-month period. Despite having declared their default device, Thoraxcenter interventionalists decided that they needed something other than a BVS for more than 80% of their PCI patients, Dr. Robert-Jan van Geuns reported at the annual meeting of the European Association of Percutaneous Coronary Interventions.
The data so far are limited, "from small registries," not the sort of evidence that changes practice, admitted Dr. van Geuns, "but I think we are seeing where we are going" with BVS.
"With BVS, there is the hope for therapeutic benefit with possible vessel remodeling," said Dr. Stephan Windecker, professor and chief of cardiology at University Hospital in Bern, Switzerland. "I think it may have long-term benefits that we do not see" with conventional drug-eluting metallic stents. "There is strong evidence for a different way of vessel remodeling when the scaffold disappears," said Dr. Windecker, expressing the widely held but still clinically unproven view that treating patients with stents that disappear once they’ve done their job will be better for patients than are standard metal stents that stay in place forever.
Two Rotterdam BVS registries
Dr. van Geuns did not specify all the criteria his group applied for targeting BVS, aside from saying in an interview that they were younger patients with relatively few comorbidities and a life expectancy of at least 2 years so that they could potentially benefit from long-term advantages after a BVS disappears.
The Thoraxcenter’s 174 BVS-treated patients included 41 patients with a ST-elevation myocardial infarction who entered a separate review, two with prior coronary artery bypass surgery, and 131 who underwent PCI for other reasons who were the focus of Dr. van Geuns’ report. Procedural and clinical success occurred in 126 of the 131 patients (95%). The only complications during median follow-up of 137 days were two cases of stent thrombosis, one myocardial infarction in a nontarget vessel that occurred during the first 30 days after treatment, and one death. The operators generally found BVS to be deliverable, though with longer procedure times, more wires needed, and more predilatation of the PCI vessel, compared with what’s usual for placing metallic coronary stents.
The Polish ACS registry
Two other series reported at the meeting used BVS as the default device in patients with acute coronary syndrome (ACS). The POLAR ACS (Polish Absorb Registry for ACS) enrolled 88 ACS patients who received at least one BVS during November 2012-May 2013 when participating centers used BVS as their default devices for PCI. Treatment also included aspiration thrombectomy in 15 patients (17%), and predilatation of the infarct-related artery in 78 patients (89%).
The BVS intervention had 100% procedural success and produced robust, TIMI grade III flow in all of the treated patients, reported Dr. Dariusz Dudek, professor and head of interventional cardiology at Jagiellonian University in Krakow, Poland. The BVS was "easy to deliver," he said. But after predilatation and before BVS placement, one patient had no reflow and two had slow flow. Following completion of the procedure, one patient continued to have slow flow and four patients needed bail-out placement of another BVS. The only major adverse coronary event during hospitalization was need for PCI outside the target vessel.
"The data indicate at least similar safety and efficacy for BVS as for current drug-eluting stents," said Dr. Dudek, We can start replacing drug-eluting metal stents with BVS in many cases, especially for focal stenoses in younger patients."
But Dr. Chaim Lotan voiced concern about the incidence of low and slow blood flow during and after the ACS procedures. "Reduction of flow predicts mortality," he warned. "I think this is related to the aggressive vessel preparation," said Dr. Lotan, director of the heart institute at Hadassah Medical Center in Jerusalem.
Dr. Dudek acknowledged that the predilatation with a noncompliant balloon that BVS requires can trigger slow or no flow in the infarct vessel.
In response, Dr. Ron Waksman defended the BVS concept. "We see 4% restenosis after 3 years, and 6% after 4 years" with conventional drug-eluting metal stents. "These are unacceptable numbers. BVS is a new technology that guarantees that after 3 years there is no stent," said Dr. Waksman, associate director of cardiology at MedStar Washington Hospital Center.
The Czech STEMI registry
A third European registry of default BVS that began late last year focused on patients treated for ST-elevation MI at a participating center in the Czech Republic during December 2012-May 2013. Of the 87 patients who presented at participating centers with STEMI, 22 patients (25%) met prespecified criteria for undergoing BVS treatment, a BVS penetration level similar to the rate in the Thoraxcenter series. One eligibility criteria was life expectancy of at least 3 years. The 21-treated patients received 27 of 28 BVS successfully; one BVS could not be placed because of vessel tortuosity. Nineteen of the 21-BVS-treated patients achieved TIMI III grade coronary flow after PCI, with the other two patients reaching grade II flow, reported Dr. Petr Widimský, professor and head of the cardiocenter at Charles University in Prague. Common reasons why STEMI patients did not receive a BVS included no stent needed; a vessel too wide (more than 4.0 mm) to be treated by existing BVS sizes; or the presence of pulmonary edema or shock. During follow-up, one patient had a reinfarction caused by BVS thrombosis 3 days after stopping ticagrelor, but no patients had any episodes of clinical restenosis during follow-up of up to 5 months.
Based on the experience so far in three reported programs using BVS to treat patients with STEMI the key for successful use in these patients seems to be treating appropriately-sized coronary arteries because the possibility to post-dilate the BVS without breaking it is limited, said Dr. van Geuns.
Despite limited experience so far using BVS in routine practice, experts see the penetration the devices have made so far as a model for the future of interventional cardiology. During one panel discussion on BVS at the meeting, the widely shared consensus was that within a decade BVS numbers will surpass metallic stents for PCI and truly be the default device, with use in three-quarters or more of PCI patients.
A larger BVS registry
A larger record of BVS performance reported at the meeting came from a registry of 450 patients followed for 1 year after receiving one or two BVS at centers that participated in the ABSORB EXTEND trial. Average lesion length treated was just under 12 mm, and 93% of patients had a single lesion. During 12 months of follow-up, patients had one death, 13 myocardial infarctions, and eight instances of ischemia-driven target-vessel revascularization, for an overall major adverse event rate of 4.2%, reported Dr. Patrick W. Serruys, professor of interventional cardiology at the Thoraxcenter. Four cases of scaffold thrombosis (0.9%) occurred during 1 year follow-up.
Dr. Serruys showed how the BVS outcomes from the 450 patients in this registry compared with a historical series of patients who received the Xience V everolimus-eluting coronary stent in the SPIRIT II (Eurointervention 2007;3:315-20) and SPIRIT III (JAMA 2008:299:1903-13) trials. The 12-month major adverse cardiac events (MACE) rate of 4.2%, scaffold thrombosis rate of 0.9%, and the 2.9% MI rate seen with the Absorb BVS in the registry compared well with the 5.3% MACE rate, 0.7% definite stent thrombosis rate, and 2.3% MI rate seen with Xience V in the two older trials, Dr. Serruys noted. The BVS had no significant safety and efficacy differences, compared with historic results from a drug-eluting, metallic stent comparator, but with the added potential benefit of disappearing from the patient.
High expectations for BVS
"The noninferiority of BVS has been well established in patients with simple [coronary] disease, but in patients with diffuse disease, BVS may well be superior," said Dr. Ibrahim Al-Rashdan, director of the cardiac catheterization laboratory at in Kuwait Heart Center. "We can use BVS to avoid a metal jacket with diffuse disease. But lesion preparation and good vessel sizing is mandatory. And if the vessel is calcified you must use a rotablator; if you have any doubt, use a rotablator." Another limitation of BVS is that because they are made from polymers, they break when overexpanded, and the currently available models are bulkier than metallic stents and their bulkiness demands predilatation of the artery receiving a BVS. "There is consensus to use BVS for long lesions, and for patients with diabetes," said Dr. van Geuns.
But despite this support for BVS, their reception may be tepid so far at the grassroots’ level. "People are afraid of BVS because it’s a plastic stent," said Dr. Dudek. But while he conceded that BVS use requires precautions, "the technique is not so different from a regular DES [drug-eluting stent]," he said.
"The ideal lesions for BVS are soft, with no calcifications, and enough compliance of the vessel wall to accommodate the device so you don’t need to worry about full stent expansion. With BVS, there is hope to have therapeutic benefit with possible vessel remodeling." said Dr. Windecker. "There is strong evidence for a different way of vessel remodeling" with lesion regression. "This may also happen with metal stents, but with a metal stent, the remodeling won’t benefit the lumen because of the metallic wires. We have preliminary data from coronary imaging that the coronary seems to grow" around a BVS "in a way that does not compromise the lumen," Dr. Windecker said in an interview.
A focus for continued BVS development will be patients with diabetes because of the "clear limitation of drug-eluting stents" in these patients, he said. Future studies will also try to establish that BVS can prevent plaque rupture.
Dr. van Geuns said that he has been a consultant to and received honoraria from Stentys and Abbott Vascular. Dr. Windecker said that he has received grant support from Abbott, Biotronik, Boston Scientific, and several other companies. Dr. Dudek said that he has been a consultant to Biotronik, Abbott, Medtronic, and Boston Scientific. Dr. Lotan said that he has been a consultant to and stockholder in InspireMD and that he has received honoraria from Medtronic and other companies. Dr. Waksman said that he has been a consultant to Biotronik, Abbott Vascular, Boston Scientific, and Medtronic. Dr. Widimský said that he has been a consultant to Abbott Vascular, Boston Scientific, Medtronic, and several other companies. Dr. Serruys said that he had no disclosures. Dr. Al-Rashdan said that he had no disclosures.
On Twitter @mitchelzoler
PARIS – Bioresorbable coronary stents programmed to disappear look like they are here to stay.
Late last year, interventional cardiology began its slow but inexorable shift from metallic coronary stents to bioresorbable scaffolds that disappear from arteries within a couple of years, and in newer models, within several months.
The first bioresorbable coronary stent, called a bioresorbable vascular scaffold (BVS), came out for routine use in Europe last September under the brand name Absorb. While the U.S. pivotal trial for this BVS launched only in January, as early as last September interventionalists at a few European centers felt so convinced by the BVS concept that they designated it their "default" device for percutaneous coronary interventions (PCI). While early European results from more than 200 patients treated with default BVS were generally encouraging, although not without a problem, default BVS currently operates with enough exclusions and caveats to warrant a big asterisk.
A major lesson from "default" use of BVS is that they are clearly not for everyone right now. The largest default bioresorbable program reported so far includes 176 BVS placed by PCI in 174 patients during September 2012 through April 2013 at the Thoraxcenter in Rotterdam. Those 176 interventions were out of 1,018 procedures done in 958 patients during the same 8-month period. Despite having declared their default device, Thoraxcenter interventionalists decided that they needed something other than a BVS for more than 80% of their PCI patients, Dr. Robert-Jan van Geuns reported at the annual meeting of the European Association of Percutaneous Coronary Interventions.
The data so far are limited, "from small registries," not the sort of evidence that changes practice, admitted Dr. van Geuns, "but I think we are seeing where we are going" with BVS.
"With BVS, there is the hope for therapeutic benefit with possible vessel remodeling," said Dr. Stephan Windecker, professor and chief of cardiology at University Hospital in Bern, Switzerland. "I think it may have long-term benefits that we do not see" with conventional drug-eluting metallic stents. "There is strong evidence for a different way of vessel remodeling when the scaffold disappears," said Dr. Windecker, expressing the widely held but still clinically unproven view that treating patients with stents that disappear once they’ve done their job will be better for patients than are standard metal stents that stay in place forever.
Two Rotterdam BVS registries
Dr. van Geuns did not specify all the criteria his group applied for targeting BVS, aside from saying in an interview that they were younger patients with relatively few comorbidities and a life expectancy of at least 2 years so that they could potentially benefit from long-term advantages after a BVS disappears.
The Thoraxcenter’s 174 BVS-treated patients included 41 patients with a ST-elevation myocardial infarction who entered a separate review, two with prior coronary artery bypass surgery, and 131 who underwent PCI for other reasons who were the focus of Dr. van Geuns’ report. Procedural and clinical success occurred in 126 of the 131 patients (95%). The only complications during median follow-up of 137 days were two cases of stent thrombosis, one myocardial infarction in a nontarget vessel that occurred during the first 30 days after treatment, and one death. The operators generally found BVS to be deliverable, though with longer procedure times, more wires needed, and more predilatation of the PCI vessel, compared with what’s usual for placing metallic coronary stents.
The Polish ACS registry
Two other series reported at the meeting used BVS as the default device in patients with acute coronary syndrome (ACS). The POLAR ACS (Polish Absorb Registry for ACS) enrolled 88 ACS patients who received at least one BVS during November 2012-May 2013 when participating centers used BVS as their default devices for PCI. Treatment also included aspiration thrombectomy in 15 patients (17%), and predilatation of the infarct-related artery in 78 patients (89%).
The BVS intervention had 100% procedural success and produced robust, TIMI grade III flow in all of the treated patients, reported Dr. Dariusz Dudek, professor and head of interventional cardiology at Jagiellonian University in Krakow, Poland. The BVS was "easy to deliver," he said. But after predilatation and before BVS placement, one patient had no reflow and two had slow flow. Following completion of the procedure, one patient continued to have slow flow and four patients needed bail-out placement of another BVS. The only major adverse coronary event during hospitalization was need for PCI outside the target vessel.
"The data indicate at least similar safety and efficacy for BVS as for current drug-eluting stents," said Dr. Dudek, We can start replacing drug-eluting metal stents with BVS in many cases, especially for focal stenoses in younger patients."
But Dr. Chaim Lotan voiced concern about the incidence of low and slow blood flow during and after the ACS procedures. "Reduction of flow predicts mortality," he warned. "I think this is related to the aggressive vessel preparation," said Dr. Lotan, director of the heart institute at Hadassah Medical Center in Jerusalem.
Dr. Dudek acknowledged that the predilatation with a noncompliant balloon that BVS requires can trigger slow or no flow in the infarct vessel.
In response, Dr. Ron Waksman defended the BVS concept. "We see 4% restenosis after 3 years, and 6% after 4 years" with conventional drug-eluting metal stents. "These are unacceptable numbers. BVS is a new technology that guarantees that after 3 years there is no stent," said Dr. Waksman, associate director of cardiology at MedStar Washington Hospital Center.
The Czech STEMI registry
A third European registry of default BVS that began late last year focused on patients treated for ST-elevation MI at a participating center in the Czech Republic during December 2012-May 2013. Of the 87 patients who presented at participating centers with STEMI, 22 patients (25%) met prespecified criteria for undergoing BVS treatment, a BVS penetration level similar to the rate in the Thoraxcenter series. One eligibility criteria was life expectancy of at least 3 years. The 21-treated patients received 27 of 28 BVS successfully; one BVS could not be placed because of vessel tortuosity. Nineteen of the 21-BVS-treated patients achieved TIMI III grade coronary flow after PCI, with the other two patients reaching grade II flow, reported Dr. Petr Widimský, professor and head of the cardiocenter at Charles University in Prague. Common reasons why STEMI patients did not receive a BVS included no stent needed; a vessel too wide (more than 4.0 mm) to be treated by existing BVS sizes; or the presence of pulmonary edema or shock. During follow-up, one patient had a reinfarction caused by BVS thrombosis 3 days after stopping ticagrelor, but no patients had any episodes of clinical restenosis during follow-up of up to 5 months.
Based on the experience so far in three reported programs using BVS to treat patients with STEMI the key for successful use in these patients seems to be treating appropriately-sized coronary arteries because the possibility to post-dilate the BVS without breaking it is limited, said Dr. van Geuns.
Despite limited experience so far using BVS in routine practice, experts see the penetration the devices have made so far as a model for the future of interventional cardiology. During one panel discussion on BVS at the meeting, the widely shared consensus was that within a decade BVS numbers will surpass metallic stents for PCI and truly be the default device, with use in three-quarters or more of PCI patients.
A larger BVS registry
A larger record of BVS performance reported at the meeting came from a registry of 450 patients followed for 1 year after receiving one or two BVS at centers that participated in the ABSORB EXTEND trial. Average lesion length treated was just under 12 mm, and 93% of patients had a single lesion. During 12 months of follow-up, patients had one death, 13 myocardial infarctions, and eight instances of ischemia-driven target-vessel revascularization, for an overall major adverse event rate of 4.2%, reported Dr. Patrick W. Serruys, professor of interventional cardiology at the Thoraxcenter. Four cases of scaffold thrombosis (0.9%) occurred during 1 year follow-up.
Dr. Serruys showed how the BVS outcomes from the 450 patients in this registry compared with a historical series of patients who received the Xience V everolimus-eluting coronary stent in the SPIRIT II (Eurointervention 2007;3:315-20) and SPIRIT III (JAMA 2008:299:1903-13) trials. The 12-month major adverse cardiac events (MACE) rate of 4.2%, scaffold thrombosis rate of 0.9%, and the 2.9% MI rate seen with the Absorb BVS in the registry compared well with the 5.3% MACE rate, 0.7% definite stent thrombosis rate, and 2.3% MI rate seen with Xience V in the two older trials, Dr. Serruys noted. The BVS had no significant safety and efficacy differences, compared with historic results from a drug-eluting, metallic stent comparator, but with the added potential benefit of disappearing from the patient.
High expectations for BVS
"The noninferiority of BVS has been well established in patients with simple [coronary] disease, but in patients with diffuse disease, BVS may well be superior," said Dr. Ibrahim Al-Rashdan, director of the cardiac catheterization laboratory at in Kuwait Heart Center. "We can use BVS to avoid a metal jacket with diffuse disease. But lesion preparation and good vessel sizing is mandatory. And if the vessel is calcified you must use a rotablator; if you have any doubt, use a rotablator." Another limitation of BVS is that because they are made from polymers, they break when overexpanded, and the currently available models are bulkier than metallic stents and their bulkiness demands predilatation of the artery receiving a BVS. "There is consensus to use BVS for long lesions, and for patients with diabetes," said Dr. van Geuns.
But despite this support for BVS, their reception may be tepid so far at the grassroots’ level. "People are afraid of BVS because it’s a plastic stent," said Dr. Dudek. But while he conceded that BVS use requires precautions, "the technique is not so different from a regular DES [drug-eluting stent]," he said.
"The ideal lesions for BVS are soft, with no calcifications, and enough compliance of the vessel wall to accommodate the device so you don’t need to worry about full stent expansion. With BVS, there is hope to have therapeutic benefit with possible vessel remodeling." said Dr. Windecker. "There is strong evidence for a different way of vessel remodeling" with lesion regression. "This may also happen with metal stents, but with a metal stent, the remodeling won’t benefit the lumen because of the metallic wires. We have preliminary data from coronary imaging that the coronary seems to grow" around a BVS "in a way that does not compromise the lumen," Dr. Windecker said in an interview.
A focus for continued BVS development will be patients with diabetes because of the "clear limitation of drug-eluting stents" in these patients, he said. Future studies will also try to establish that BVS can prevent plaque rupture.
Dr. van Geuns said that he has been a consultant to and received honoraria from Stentys and Abbott Vascular. Dr. Windecker said that he has received grant support from Abbott, Biotronik, Boston Scientific, and several other companies. Dr. Dudek said that he has been a consultant to Biotronik, Abbott, Medtronic, and Boston Scientific. Dr. Lotan said that he has been a consultant to and stockholder in InspireMD and that he has received honoraria from Medtronic and other companies. Dr. Waksman said that he has been a consultant to Biotronik, Abbott Vascular, Boston Scientific, and Medtronic. Dr. Widimský said that he has been a consultant to Abbott Vascular, Boston Scientific, Medtronic, and several other companies. Dr. Serruys said that he had no disclosures. Dr. Al-Rashdan said that he had no disclosures.
On Twitter @mitchelzoler
PARIS – Bioresorbable coronary stents programmed to disappear look like they are here to stay.
Late last year, interventional cardiology began its slow but inexorable shift from metallic coronary stents to bioresorbable scaffolds that disappear from arteries within a couple of years, and in newer models, within several months.
The first bioresorbable coronary stent, called a bioresorbable vascular scaffold (BVS), came out for routine use in Europe last September under the brand name Absorb. While the U.S. pivotal trial for this BVS launched only in January, as early as last September interventionalists at a few European centers felt so convinced by the BVS concept that they designated it their "default" device for percutaneous coronary interventions (PCI). While early European results from more than 200 patients treated with default BVS were generally encouraging, although not without a problem, default BVS currently operates with enough exclusions and caveats to warrant a big asterisk.
A major lesson from "default" use of BVS is that they are clearly not for everyone right now. The largest default bioresorbable program reported so far includes 176 BVS placed by PCI in 174 patients during September 2012 through April 2013 at the Thoraxcenter in Rotterdam. Those 176 interventions were out of 1,018 procedures done in 958 patients during the same 8-month period. Despite having declared their default device, Thoraxcenter interventionalists decided that they needed something other than a BVS for more than 80% of their PCI patients, Dr. Robert-Jan van Geuns reported at the annual meeting of the European Association of Percutaneous Coronary Interventions.
The data so far are limited, "from small registries," not the sort of evidence that changes practice, admitted Dr. van Geuns, "but I think we are seeing where we are going" with BVS.
"With BVS, there is the hope for therapeutic benefit with possible vessel remodeling," said Dr. Stephan Windecker, professor and chief of cardiology at University Hospital in Bern, Switzerland. "I think it may have long-term benefits that we do not see" with conventional drug-eluting metallic stents. "There is strong evidence for a different way of vessel remodeling when the scaffold disappears," said Dr. Windecker, expressing the widely held but still clinically unproven view that treating patients with stents that disappear once they’ve done their job will be better for patients than are standard metal stents that stay in place forever.
Two Rotterdam BVS registries
Dr. van Geuns did not specify all the criteria his group applied for targeting BVS, aside from saying in an interview that they were younger patients with relatively few comorbidities and a life expectancy of at least 2 years so that they could potentially benefit from long-term advantages after a BVS disappears.
The Thoraxcenter’s 174 BVS-treated patients included 41 patients with a ST-elevation myocardial infarction who entered a separate review, two with prior coronary artery bypass surgery, and 131 who underwent PCI for other reasons who were the focus of Dr. van Geuns’ report. Procedural and clinical success occurred in 126 of the 131 patients (95%). The only complications during median follow-up of 137 days were two cases of stent thrombosis, one myocardial infarction in a nontarget vessel that occurred during the first 30 days after treatment, and one death. The operators generally found BVS to be deliverable, though with longer procedure times, more wires needed, and more predilatation of the PCI vessel, compared with what’s usual for placing metallic coronary stents.
The Polish ACS registry
Two other series reported at the meeting used BVS as the default device in patients with acute coronary syndrome (ACS). The POLAR ACS (Polish Absorb Registry for ACS) enrolled 88 ACS patients who received at least one BVS during November 2012-May 2013 when participating centers used BVS as their default devices for PCI. Treatment also included aspiration thrombectomy in 15 patients (17%), and predilatation of the infarct-related artery in 78 patients (89%).
The BVS intervention had 100% procedural success and produced robust, TIMI grade III flow in all of the treated patients, reported Dr. Dariusz Dudek, professor and head of interventional cardiology at Jagiellonian University in Krakow, Poland. The BVS was "easy to deliver," he said. But after predilatation and before BVS placement, one patient had no reflow and two had slow flow. Following completion of the procedure, one patient continued to have slow flow and four patients needed bail-out placement of another BVS. The only major adverse coronary event during hospitalization was need for PCI outside the target vessel.
"The data indicate at least similar safety and efficacy for BVS as for current drug-eluting stents," said Dr. Dudek, We can start replacing drug-eluting metal stents with BVS in many cases, especially for focal stenoses in younger patients."
But Dr. Chaim Lotan voiced concern about the incidence of low and slow blood flow during and after the ACS procedures. "Reduction of flow predicts mortality," he warned. "I think this is related to the aggressive vessel preparation," said Dr. Lotan, director of the heart institute at Hadassah Medical Center in Jerusalem.
Dr. Dudek acknowledged that the predilatation with a noncompliant balloon that BVS requires can trigger slow or no flow in the infarct vessel.
In response, Dr. Ron Waksman defended the BVS concept. "We see 4% restenosis after 3 years, and 6% after 4 years" with conventional drug-eluting metal stents. "These are unacceptable numbers. BVS is a new technology that guarantees that after 3 years there is no stent," said Dr. Waksman, associate director of cardiology at MedStar Washington Hospital Center.
The Czech STEMI registry
A third European registry of default BVS that began late last year focused on patients treated for ST-elevation MI at a participating center in the Czech Republic during December 2012-May 2013. Of the 87 patients who presented at participating centers with STEMI, 22 patients (25%) met prespecified criteria for undergoing BVS treatment, a BVS penetration level similar to the rate in the Thoraxcenter series. One eligibility criteria was life expectancy of at least 3 years. The 21-treated patients received 27 of 28 BVS successfully; one BVS could not be placed because of vessel tortuosity. Nineteen of the 21-BVS-treated patients achieved TIMI III grade coronary flow after PCI, with the other two patients reaching grade II flow, reported Dr. Petr Widimský, professor and head of the cardiocenter at Charles University in Prague. Common reasons why STEMI patients did not receive a BVS included no stent needed; a vessel too wide (more than 4.0 mm) to be treated by existing BVS sizes; or the presence of pulmonary edema or shock. During follow-up, one patient had a reinfarction caused by BVS thrombosis 3 days after stopping ticagrelor, but no patients had any episodes of clinical restenosis during follow-up of up to 5 months.
Based on the experience so far in three reported programs using BVS to treat patients with STEMI the key for successful use in these patients seems to be treating appropriately-sized coronary arteries because the possibility to post-dilate the BVS without breaking it is limited, said Dr. van Geuns.
Despite limited experience so far using BVS in routine practice, experts see the penetration the devices have made so far as a model for the future of interventional cardiology. During one panel discussion on BVS at the meeting, the widely shared consensus was that within a decade BVS numbers will surpass metallic stents for PCI and truly be the default device, with use in three-quarters or more of PCI patients.
A larger BVS registry
A larger record of BVS performance reported at the meeting came from a registry of 450 patients followed for 1 year after receiving one or two BVS at centers that participated in the ABSORB EXTEND trial. Average lesion length treated was just under 12 mm, and 93% of patients had a single lesion. During 12 months of follow-up, patients had one death, 13 myocardial infarctions, and eight instances of ischemia-driven target-vessel revascularization, for an overall major adverse event rate of 4.2%, reported Dr. Patrick W. Serruys, professor of interventional cardiology at the Thoraxcenter. Four cases of scaffold thrombosis (0.9%) occurred during 1 year follow-up.
Dr. Serruys showed how the BVS outcomes from the 450 patients in this registry compared with a historical series of patients who received the Xience V everolimus-eluting coronary stent in the SPIRIT II (Eurointervention 2007;3:315-20) and SPIRIT III (JAMA 2008:299:1903-13) trials. The 12-month major adverse cardiac events (MACE) rate of 4.2%, scaffold thrombosis rate of 0.9%, and the 2.9% MI rate seen with the Absorb BVS in the registry compared well with the 5.3% MACE rate, 0.7% definite stent thrombosis rate, and 2.3% MI rate seen with Xience V in the two older trials, Dr. Serruys noted. The BVS had no significant safety and efficacy differences, compared with historic results from a drug-eluting, metallic stent comparator, but with the added potential benefit of disappearing from the patient.
High expectations for BVS
"The noninferiority of BVS has been well established in patients with simple [coronary] disease, but in patients with diffuse disease, BVS may well be superior," said Dr. Ibrahim Al-Rashdan, director of the cardiac catheterization laboratory at in Kuwait Heart Center. "We can use BVS to avoid a metal jacket with diffuse disease. But lesion preparation and good vessel sizing is mandatory. And if the vessel is calcified you must use a rotablator; if you have any doubt, use a rotablator." Another limitation of BVS is that because they are made from polymers, they break when overexpanded, and the currently available models are bulkier than metallic stents and their bulkiness demands predilatation of the artery receiving a BVS. "There is consensus to use BVS for long lesions, and for patients with diabetes," said Dr. van Geuns.
But despite this support for BVS, their reception may be tepid so far at the grassroots’ level. "People are afraid of BVS because it’s a plastic stent," said Dr. Dudek. But while he conceded that BVS use requires precautions, "the technique is not so different from a regular DES [drug-eluting stent]," he said.
"The ideal lesions for BVS are soft, with no calcifications, and enough compliance of the vessel wall to accommodate the device so you don’t need to worry about full stent expansion. With BVS, there is hope to have therapeutic benefit with possible vessel remodeling." said Dr. Windecker. "There is strong evidence for a different way of vessel remodeling" with lesion regression. "This may also happen with metal stents, but with a metal stent, the remodeling won’t benefit the lumen because of the metallic wires. We have preliminary data from coronary imaging that the coronary seems to grow" around a BVS "in a way that does not compromise the lumen," Dr. Windecker said in an interview.
A focus for continued BVS development will be patients with diabetes because of the "clear limitation of drug-eluting stents" in these patients, he said. Future studies will also try to establish that BVS can prevent plaque rupture.
Dr. van Geuns said that he has been a consultant to and received honoraria from Stentys and Abbott Vascular. Dr. Windecker said that he has received grant support from Abbott, Biotronik, Boston Scientific, and several other companies. Dr. Dudek said that he has been a consultant to Biotronik, Abbott, Medtronic, and Boston Scientific. Dr. Lotan said that he has been a consultant to and stockholder in InspireMD and that he has received honoraria from Medtronic and other companies. Dr. Waksman said that he has been a consultant to Biotronik, Abbott Vascular, Boston Scientific, and Medtronic. Dr. Widimský said that he has been a consultant to Abbott Vascular, Boston Scientific, Medtronic, and several other companies. Dr. Serruys said that he had no disclosures. Dr. Al-Rashdan said that he had no disclosures.
On Twitter @mitchelzoler
EXPERT OPINION FROM EUROPCR 2013
DESolve Bioresorbable stent speeds coronary healing
PARIS – The monopoly Absorb has held in Europe since last September as the only bioresorbable vascular scaffold on the market is at an end.
In May, Elixir, a company that makes its own version of a different bioresorbable vascular scaffold (BVS), announced it received permission from the European Commission to market its DESolve BVS.
DESolve differs from Absorb by substantially disappearing within 6 months of placement with full resorption within a year, roughly twice the disappearing speed of Absorb, the first bioresorbable vascular scaffold on the European market.
This difference may have affected performance, said Dr. Alexandre Abizaid, who reported on a multicenter series of 126 patients who received DESolve BVS in a talk at the annual meeting of the European Association of Percutaneous Coronary Interventions.
"We got the same results after 6 months with this device as we see with Absorb after 2 or 3 years," said Dr. Abizaid, chief of coronary interventions at the Dante Pazzanese Cardiology Institute in São Paulo, Brazil."We saw the benefit from a BVS early on, with lumen enlargement and vessel enlargement.
"I would use this devise on the types of patients included in the study; younger patients with relatively short lesions, about 12 mm; patients who could benefit from vessel restoration; patients who might need coronary artery bypass surgery in the future; and patients with diabetes who seem to get the same results with this BVS as other patients. As we get more confident with the acute and long-term performance, we will expand the indications," Dr. Abizaid said.
Another feature of the DESolve BVS is that the 3.0-mm–diameter model can be balloon expanded to 4.8 mm before breaking, in contrast to the Absorb BVS, which can break when overexpansion surpasses 0.5 mm.
The results Dr. Abizaid reported on DESolve "led to the CE mark for the device. It will surely change our practice," commented Dr. Robert A. Byrne, an interventional cardiologist at the Heart Center in Munich. "When we have more bioresorbable scaffolds in the marketplace, we will see further development of this technology."
The DESolve Nx (notorolimus-eluting) pivotal trial included 126 patients at 13 centers in Brazil, New Zealand, and Europe. The study’s primary endpoint was the late lumen loss at 6 months, which averaged 0.21 mm, a rate that Dr. Byrne called "very good" compared with current standards.
Other measures reported by Dr. Abizaid further documented the extent of healing and vessel growth. "In the first 6 months, we usually see the lumen decrease due to scar tissue, but at 3-12 months we saw luminal enlargement that occurs as the scaffold degrades. There was a clear, statistically significant 17% increase in vessel area at 6 months, with a luminal increase of almost 10%, generally what we see after 3-4 years with Absorb," he said. In addition, imaging showed nearly 99% of all struts covered by tissue at 6 months. "The healing process is essentially complete" by then, he said.
Follow-up also showed low early recoil and no negative remodeling. In-segment binary restenosis occurred in one patient in whom the restenosis was within the scaffold, and in three patients where it occurred at the edge. During follow-up, clinically indicated revascularization was performed in two patients, a target vessel non–Q-wave myocardial infarction occurred in one patient, and cardiac death occurred in another.
"This device does its job to prevent negative remodeling in the first 4 months, and then it uncages the vessel, frees it to allow natural, positive remodeling. The potential advantages of the DESolve BVS are that degradation really happens within 1 year, and it gives you more freedom to postdilate if you need to. Having the device not fracture [during postdilation] is important," Dr. Abizaid said.
The DESolve Nx trial was sponsored by Elixir, which markets the stent. Dr. Abizaid said he has received research grants from Elixir, Abbott Vascular, Boston Scientific, and Medtronic. Dr. Byrne said his institution received research support from Biotronik.
On Twitter @mitchelzoler
PARIS – The monopoly Absorb has held in Europe since last September as the only bioresorbable vascular scaffold on the market is at an end.
In May, Elixir, a company that makes its own version of a different bioresorbable vascular scaffold (BVS), announced it received permission from the European Commission to market its DESolve BVS.
DESolve differs from Absorb by substantially disappearing within 6 months of placement with full resorption within a year, roughly twice the disappearing speed of Absorb, the first bioresorbable vascular scaffold on the European market.
This difference may have affected performance, said Dr. Alexandre Abizaid, who reported on a multicenter series of 126 patients who received DESolve BVS in a talk at the annual meeting of the European Association of Percutaneous Coronary Interventions.
"We got the same results after 6 months with this device as we see with Absorb after 2 or 3 years," said Dr. Abizaid, chief of coronary interventions at the Dante Pazzanese Cardiology Institute in São Paulo, Brazil."We saw the benefit from a BVS early on, with lumen enlargement and vessel enlargement.
"I would use this devise on the types of patients included in the study; younger patients with relatively short lesions, about 12 mm; patients who could benefit from vessel restoration; patients who might need coronary artery bypass surgery in the future; and patients with diabetes who seem to get the same results with this BVS as other patients. As we get more confident with the acute and long-term performance, we will expand the indications," Dr. Abizaid said.
Another feature of the DESolve BVS is that the 3.0-mm–diameter model can be balloon expanded to 4.8 mm before breaking, in contrast to the Absorb BVS, which can break when overexpansion surpasses 0.5 mm.
The results Dr. Abizaid reported on DESolve "led to the CE mark for the device. It will surely change our practice," commented Dr. Robert A. Byrne, an interventional cardiologist at the Heart Center in Munich. "When we have more bioresorbable scaffolds in the marketplace, we will see further development of this technology."
The DESolve Nx (notorolimus-eluting) pivotal trial included 126 patients at 13 centers in Brazil, New Zealand, and Europe. The study’s primary endpoint was the late lumen loss at 6 months, which averaged 0.21 mm, a rate that Dr. Byrne called "very good" compared with current standards.
Other measures reported by Dr. Abizaid further documented the extent of healing and vessel growth. "In the first 6 months, we usually see the lumen decrease due to scar tissue, but at 3-12 months we saw luminal enlargement that occurs as the scaffold degrades. There was a clear, statistically significant 17% increase in vessel area at 6 months, with a luminal increase of almost 10%, generally what we see after 3-4 years with Absorb," he said. In addition, imaging showed nearly 99% of all struts covered by tissue at 6 months. "The healing process is essentially complete" by then, he said.
Follow-up also showed low early recoil and no negative remodeling. In-segment binary restenosis occurred in one patient in whom the restenosis was within the scaffold, and in three patients where it occurred at the edge. During follow-up, clinically indicated revascularization was performed in two patients, a target vessel non–Q-wave myocardial infarction occurred in one patient, and cardiac death occurred in another.
"This device does its job to prevent negative remodeling in the first 4 months, and then it uncages the vessel, frees it to allow natural, positive remodeling. The potential advantages of the DESolve BVS are that degradation really happens within 1 year, and it gives you more freedom to postdilate if you need to. Having the device not fracture [during postdilation] is important," Dr. Abizaid said.
The DESolve Nx trial was sponsored by Elixir, which markets the stent. Dr. Abizaid said he has received research grants from Elixir, Abbott Vascular, Boston Scientific, and Medtronic. Dr. Byrne said his institution received research support from Biotronik.
On Twitter @mitchelzoler
PARIS – The monopoly Absorb has held in Europe since last September as the only bioresorbable vascular scaffold on the market is at an end.
In May, Elixir, a company that makes its own version of a different bioresorbable vascular scaffold (BVS), announced it received permission from the European Commission to market its DESolve BVS.
DESolve differs from Absorb by substantially disappearing within 6 months of placement with full resorption within a year, roughly twice the disappearing speed of Absorb, the first bioresorbable vascular scaffold on the European market.
This difference may have affected performance, said Dr. Alexandre Abizaid, who reported on a multicenter series of 126 patients who received DESolve BVS in a talk at the annual meeting of the European Association of Percutaneous Coronary Interventions.
"We got the same results after 6 months with this device as we see with Absorb after 2 or 3 years," said Dr. Abizaid, chief of coronary interventions at the Dante Pazzanese Cardiology Institute in São Paulo, Brazil."We saw the benefit from a BVS early on, with lumen enlargement and vessel enlargement.
"I would use this devise on the types of patients included in the study; younger patients with relatively short lesions, about 12 mm; patients who could benefit from vessel restoration; patients who might need coronary artery bypass surgery in the future; and patients with diabetes who seem to get the same results with this BVS as other patients. As we get more confident with the acute and long-term performance, we will expand the indications," Dr. Abizaid said.
Another feature of the DESolve BVS is that the 3.0-mm–diameter model can be balloon expanded to 4.8 mm before breaking, in contrast to the Absorb BVS, which can break when overexpansion surpasses 0.5 mm.
The results Dr. Abizaid reported on DESolve "led to the CE mark for the device. It will surely change our practice," commented Dr. Robert A. Byrne, an interventional cardiologist at the Heart Center in Munich. "When we have more bioresorbable scaffolds in the marketplace, we will see further development of this technology."
The DESolve Nx (notorolimus-eluting) pivotal trial included 126 patients at 13 centers in Brazil, New Zealand, and Europe. The study’s primary endpoint was the late lumen loss at 6 months, which averaged 0.21 mm, a rate that Dr. Byrne called "very good" compared with current standards.
Other measures reported by Dr. Abizaid further documented the extent of healing and vessel growth. "In the first 6 months, we usually see the lumen decrease due to scar tissue, but at 3-12 months we saw luminal enlargement that occurs as the scaffold degrades. There was a clear, statistically significant 17% increase in vessel area at 6 months, with a luminal increase of almost 10%, generally what we see after 3-4 years with Absorb," he said. In addition, imaging showed nearly 99% of all struts covered by tissue at 6 months. "The healing process is essentially complete" by then, he said.
Follow-up also showed low early recoil and no negative remodeling. In-segment binary restenosis occurred in one patient in whom the restenosis was within the scaffold, and in three patients where it occurred at the edge. During follow-up, clinically indicated revascularization was performed in two patients, a target vessel non–Q-wave myocardial infarction occurred in one patient, and cardiac death occurred in another.
"This device does its job to prevent negative remodeling in the first 4 months, and then it uncages the vessel, frees it to allow natural, positive remodeling. The potential advantages of the DESolve BVS are that degradation really happens within 1 year, and it gives you more freedom to postdilate if you need to. Having the device not fracture [during postdilation] is important," Dr. Abizaid said.
The DESolve Nx trial was sponsored by Elixir, which markets the stent. Dr. Abizaid said he has received research grants from Elixir, Abbott Vascular, Boston Scientific, and Medtronic. Dr. Byrne said his institution received research support from Biotronik.
On Twitter @mitchelzoler
AT EUROPCR 2013
Major finding: Patients averaged a 0.21-mm late lumen loss 6 months after receiving a DESolve bioresorbable vascular scaffold.
Data source: The DESolve Nx study in 126 patients with single lesions at 13 worldwide centers.
Disclosures: The DESolve Nx study was sponsored by Elixir, the company that markets the DESolve device. Dr. Abizaid said he has received research grants from Elixir, Abbott Vascular, Boston Scientific, and Medtronic. Dr. Byrne said his institution received research support from Biotronik.
Orbital atherectomy shown safe, effective in coronaries
PARIS – An atherectomy device already on the U.S. market for treating calcified lesions in peripheral arteries showed safety and efficacy for treating severely calcified coronary arteries in preparation for stenting in a pivotal, multicenter study with 443 patients.
"We believe that the orbital atherectomy system is a unique technology that appears to address an unmet need in this difficult-to-treat patient population," Dr. Jeffrey W. Chambers said at the annual meeting of the European Association of Percutaneous Cardiovascular Intervention.
Based on the data collected in the new study, Cardiovascular Systems, the company that markets the orbital atherectomy system (OAS) Diamondback 360° applied to the Food and Drug Administration in March for approval to add severe coronary artery calcification as an indication for the device. The device received FDA approval for treating peripheral arteries in 2007.
The study met its primary safety and efficacy endpoints "by a significant margin," said Dr. Chambers, director of the cardiac catheterization laboratory at the Metropolitan Heart and Vascular Institute of Allina Mercy Hospital in Minneapolis. OAS treatment resulted in a 10% rate of major adverse coronary events during 30 days following treatment, significantly less than the 17% prespecified performance goal. The procedural success rate of 89% also significantly surpassed the 82% prespecified efficacy performance goal.
"This study is very important and clinically relevant," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium, who cochaired the session where Dr. Chambers gave his report.
The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial enrolled 443 patients at 49 U.S. sites. All participants had severely calcified coronary lesions that were at least 15 mm long. The patients averaged 71 years old, and two-thirds were men. The mean lesion length was almost 19 mm, with an average stenosis rate of 84%.
Patients had a cumulative 7% rate of severe angiographic complications following OAS treatment, which included type C dissections, perforations, abrupt closures, or slow or no reflow. The only significant clinical factor associated with the occurrence of one of these complications was lesion length: The longer the lesion, the more likely a complication. The complication rates for OAS seen in this study were similar to or less than the rates reported from past studies of rotational atherectomy for treating coronary arteries, Dr. Chambers said.
Safety was defined as the combined rate of cardiac death, myocardial infarction, or need for target vessel or lesion revascularization during the 30 days after treatment. The most common of these adverse events was non–Q-wave myocardial infarction, which occurred in nearly 9% of patients. Procedural success was defined as successful stent delivery, which occurred in almost 98% of patients, minus the rate of major adverse coronary events during hospitalization.
ORBIT II’s original design called for comparing OAS with rotational atherectomy, but that plan was abandoned because rotational atherectomy devices are not approved for treating severely calcified lesions, Dr. Chambers said. "The FDA felt that no other devices do this," which led to the uncontrolled study design.
The OAS uses a special guide wire that allows direct crossing of "almost all lesions," he said. The system works by removing calcium to improve arterial compliance and allow full stent expansion; the goal of OAS treatment is not debulking or plaque removal, Dr. Chambers said. The microparticles produced during the procedure are "smaller than with rotational ablation," small enough to safely pass through capillaries.
"There is a relatively easy learning curve of a couple of cases if you have used rotational ablation," he said. "The device has a leading edge that guides you into the lesion, acting as a pathfinder. The OAS is designed to engage the hard components of plaque and flex the soft components out of the way."
The ORBIT II study was sponsored by Cardiovascular Systems, which markets the OAS. Dr. Chambers is a consultant to Cardiovascular Systems and Boston Scientific. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but he had no disclosures related to Cardiovascular Systems; he has received honoraria and research grants from Boston Scientific, which markets a rotational ablation device.
On Twitter @mitchelzoler
PARIS – An atherectomy device already on the U.S. market for treating calcified lesions in peripheral arteries showed safety and efficacy for treating severely calcified coronary arteries in preparation for stenting in a pivotal, multicenter study with 443 patients.
"We believe that the orbital atherectomy system is a unique technology that appears to address an unmet need in this difficult-to-treat patient population," Dr. Jeffrey W. Chambers said at the annual meeting of the European Association of Percutaneous Cardiovascular Intervention.
Based on the data collected in the new study, Cardiovascular Systems, the company that markets the orbital atherectomy system (OAS) Diamondback 360° applied to the Food and Drug Administration in March for approval to add severe coronary artery calcification as an indication for the device. The device received FDA approval for treating peripheral arteries in 2007.
The study met its primary safety and efficacy endpoints "by a significant margin," said Dr. Chambers, director of the cardiac catheterization laboratory at the Metropolitan Heart and Vascular Institute of Allina Mercy Hospital in Minneapolis. OAS treatment resulted in a 10% rate of major adverse coronary events during 30 days following treatment, significantly less than the 17% prespecified performance goal. The procedural success rate of 89% also significantly surpassed the 82% prespecified efficacy performance goal.
"This study is very important and clinically relevant," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium, who cochaired the session where Dr. Chambers gave his report.
The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial enrolled 443 patients at 49 U.S. sites. All participants had severely calcified coronary lesions that were at least 15 mm long. The patients averaged 71 years old, and two-thirds were men. The mean lesion length was almost 19 mm, with an average stenosis rate of 84%.
Patients had a cumulative 7% rate of severe angiographic complications following OAS treatment, which included type C dissections, perforations, abrupt closures, or slow or no reflow. The only significant clinical factor associated with the occurrence of one of these complications was lesion length: The longer the lesion, the more likely a complication. The complication rates for OAS seen in this study were similar to or less than the rates reported from past studies of rotational atherectomy for treating coronary arteries, Dr. Chambers said.
Safety was defined as the combined rate of cardiac death, myocardial infarction, or need for target vessel or lesion revascularization during the 30 days after treatment. The most common of these adverse events was non–Q-wave myocardial infarction, which occurred in nearly 9% of patients. Procedural success was defined as successful stent delivery, which occurred in almost 98% of patients, minus the rate of major adverse coronary events during hospitalization.
ORBIT II’s original design called for comparing OAS with rotational atherectomy, but that plan was abandoned because rotational atherectomy devices are not approved for treating severely calcified lesions, Dr. Chambers said. "The FDA felt that no other devices do this," which led to the uncontrolled study design.
The OAS uses a special guide wire that allows direct crossing of "almost all lesions," he said. The system works by removing calcium to improve arterial compliance and allow full stent expansion; the goal of OAS treatment is not debulking or plaque removal, Dr. Chambers said. The microparticles produced during the procedure are "smaller than with rotational ablation," small enough to safely pass through capillaries.
"There is a relatively easy learning curve of a couple of cases if you have used rotational ablation," he said. "The device has a leading edge that guides you into the lesion, acting as a pathfinder. The OAS is designed to engage the hard components of plaque and flex the soft components out of the way."
The ORBIT II study was sponsored by Cardiovascular Systems, which markets the OAS. Dr. Chambers is a consultant to Cardiovascular Systems and Boston Scientific. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but he had no disclosures related to Cardiovascular Systems; he has received honoraria and research grants from Boston Scientific, which markets a rotational ablation device.
On Twitter @mitchelzoler
PARIS – An atherectomy device already on the U.S. market for treating calcified lesions in peripheral arteries showed safety and efficacy for treating severely calcified coronary arteries in preparation for stenting in a pivotal, multicenter study with 443 patients.
"We believe that the orbital atherectomy system is a unique technology that appears to address an unmet need in this difficult-to-treat patient population," Dr. Jeffrey W. Chambers said at the annual meeting of the European Association of Percutaneous Cardiovascular Intervention.
Based on the data collected in the new study, Cardiovascular Systems, the company that markets the orbital atherectomy system (OAS) Diamondback 360° applied to the Food and Drug Administration in March for approval to add severe coronary artery calcification as an indication for the device. The device received FDA approval for treating peripheral arteries in 2007.
The study met its primary safety and efficacy endpoints "by a significant margin," said Dr. Chambers, director of the cardiac catheterization laboratory at the Metropolitan Heart and Vascular Institute of Allina Mercy Hospital in Minneapolis. OAS treatment resulted in a 10% rate of major adverse coronary events during 30 days following treatment, significantly less than the 17% prespecified performance goal. The procedural success rate of 89% also significantly surpassed the 82% prespecified efficacy performance goal.
"This study is very important and clinically relevant," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium, who cochaired the session where Dr. Chambers gave his report.
The ORBIT II (Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions) trial enrolled 443 patients at 49 U.S. sites. All participants had severely calcified coronary lesions that were at least 15 mm long. The patients averaged 71 years old, and two-thirds were men. The mean lesion length was almost 19 mm, with an average stenosis rate of 84%.
Patients had a cumulative 7% rate of severe angiographic complications following OAS treatment, which included type C dissections, perforations, abrupt closures, or slow or no reflow. The only significant clinical factor associated with the occurrence of one of these complications was lesion length: The longer the lesion, the more likely a complication. The complication rates for OAS seen in this study were similar to or less than the rates reported from past studies of rotational atherectomy for treating coronary arteries, Dr. Chambers said.
Safety was defined as the combined rate of cardiac death, myocardial infarction, or need for target vessel or lesion revascularization during the 30 days after treatment. The most common of these adverse events was non–Q-wave myocardial infarction, which occurred in nearly 9% of patients. Procedural success was defined as successful stent delivery, which occurred in almost 98% of patients, minus the rate of major adverse coronary events during hospitalization.
ORBIT II’s original design called for comparing OAS with rotational atherectomy, but that plan was abandoned because rotational atherectomy devices are not approved for treating severely calcified lesions, Dr. Chambers said. "The FDA felt that no other devices do this," which led to the uncontrolled study design.
The OAS uses a special guide wire that allows direct crossing of "almost all lesions," he said. The system works by removing calcium to improve arterial compliance and allow full stent expansion; the goal of OAS treatment is not debulking or plaque removal, Dr. Chambers said. The microparticles produced during the procedure are "smaller than with rotational ablation," small enough to safely pass through capillaries.
"There is a relatively easy learning curve of a couple of cases if you have used rotational ablation," he said. "The device has a leading edge that guides you into the lesion, acting as a pathfinder. The OAS is designed to engage the hard components of plaque and flex the soft components out of the way."
The ORBIT II study was sponsored by Cardiovascular Systems, which markets the OAS. Dr. Chambers is a consultant to Cardiovascular Systems and Boston Scientific. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but he had no disclosures related to Cardiovascular Systems; he has received honoraria and research grants from Boston Scientific, which markets a rotational ablation device.
On Twitter @mitchelzoler
AT EUROPCR 2013
Major finding: Orbital atherectomy had an 89% procedural success rate and a 10% rate of major adverse coronary events during 30 days after treatment.
Data source: The ORBIT II study, an uncontrolled, open-label study of orbital atherectomy in 443 patients with severely calcified coronary arteries at 49 U.S. sites.
Disclosures: The ORBIT II study was sponsored by Cardiovascular Systems, which markets the orbital atherectomy system. Dr. Chambers said he is a consultant to Cardiovascular Systems and Boston Scientific. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but he had no disclosures related to Cardiovascular Systems; he has received honoraria and research grants from Boston Scientific, which markets a rotational ablation device.
Twice daily regimen eases aspirin resistance in diabetes
PARIS – Twice-daily dosing with aspirin worked substantially better for blocking platelet aggregation than did once-daily treatment with the same total dosage, in patients with diabetes and coronary artery disease in a single-center crossover study with 92 patients.
Patients with diabetes are often less responsive to aspirin treatment for secondary prevention of cardiovascular events than are patients without diabetes, apparently because of faster platelet turnover in patients with diabetes, Dr. Jean-Guillaume Dillinger said at the annual meeting of the European Association for Percutaneous Cardiovascular Interventions. Because aspirin levels sufficient to dampen platelet aggregation persist only for about 2 hours following a dose, faster platelet turnover leads to fewer platelets exposed to an adequate aspirin level, increased aspirin resistance, and greater thrombotic potential.
"The results of our study offer a new option to overcome biological aspirin resistance in patients with diabetes," said Dr. Dillinger, a cardiologist at Lariboisière Hospital in Paris. But Dr. Dillinger also cautioned that "large, prospective trials are needed to test if aspirin twice daily can decrease the rate of atherothrombotic events without increasing side effects such as gastrointestinal toxicity." Another potential drawback of twice-daily dosing is that patient compliance with the regimen may be reduced.
Dr. Dillinger also stressed that his study specifically enrolled patients with diabetes with at least one additional risk factor for loss of aspirin efficacy: They were either smokers or had elevated inflammatory markers, and hence, "the results cannot be extrapolated to the whole population of patients with diabetes and coronary artery disease." But he estimated that more than half of patients with diabetes and coronary artery disease (CAD) likely have at least one of these increased-risk factors.
"The results from Dr. Dillinger’s pharmacodynamic study show that a twice-daily regimen may offer greater antiplatelet effects than once daily and are in line with the results from prior investigations," commented Dr. Dominick J. Angiolillo, director of the Cardiovascular Research and Thrombosis Research Center at the University of Florida in Jacksonville. "The data support that [a twice-daily] regimen can be an effective strategy to improve response profiles, but this was a pharmacodynamic study and no conclusions can be made from the results on its clinical efficacy of safety. Clinical studies are warranted to support a change in practice," he said in an interview.
Dr. Dillinger and his associates enrolled 92 patients with diabetes and angiography-confirmed CAD who were already on aspirin treatment. All patients had been first diagnosed with diabetes after they were 30 years old, and they had not received insulin as their initial diabetes treatment unless their treatment had begun during an episode of acute coronary syndrome. In addition, all enrolled patients had at least one of these additional risk factors: current smoker, a high-sensitivity C-reaction protein (hsCRP) level of more than 4 mg/L, a fibrinogen level of more than 4 g/L, or a platelet count of more than 270,000/mm3.
The patients averaged 64 years old, 85% were men, and they entered the study an average of 12 years following their diabetes diagnosis. Of the 92 patients, 48% had one high-risk marker, 30% had two, 15% had three, and 7% had all four of the high-risk markers. Forty-eight (52%) of the patients entered the study on a daily clopidogrel regimen, and that treatment continued.
Patients were randomized to receive either 150 mg aspirin once daily taken every morning for 7-14 days before blood sampling, or 75 mg of aspirin taken twice daily, once in the morning and once in the evening for 7-14 days before their blood was drawn. Following the blood draw, they immediately switched to the alternative regimen that again continued for 7-14 days before the researchers took a second blood sample.
They assessed aspirin resistance by measuring platelet aggregation of each blood specimen using light transmission aggregometry. Specimens that produced a maximum aggregation intensity of at least 20% were considered to indicate aspirin resistance.
Testing revealed aspirin resistance in 39 (42%) patients when the study group received aspirin once daily, and in 16 patients (17%) when they were on the twice-daily regimen, a statistically significant difference.
When the 39 patients who showed aspirin resistance on the once-daily dosage were switched to twice-daily, 24 became aspirin responders on the twice-daily schedule. In contrast, among the 16 patients who were aspirin resistant on twice-daily treatment, 1 patient became responsive on the once-daily regimen, Dr. Dillinger reported.
The researchers also applied a second measure of platelet function – global platelet reactivity – using a platelet function analyzer. By this measure, they found that 38 (41%) of patients had normal platelet reactivity with once-daily aspirin, compared with 27 (29%) when patients were on twice-daily treatment. Within the subgroup of 27 patients who were resistant on either of the two regimens but not the other, 19 (70%) became responders when switched to the bid regimen, with 8 (30%) becoming responders when switched to once daily, a statistically significant difference between the two regimens.
Clopidogrel treatment had no discernable impact on the links between dosing frequency and aspirin’s antiplatelet effects.
A multivariate analysis of factors potentially affecting aspirin’s antiplatelet effect found that twice-daily treatment linked with a statistically significant 79% cut in the likelihood of aspirin resistance, compared with once daily. The only other parameter measured with a significant impact on aspirin resistance in this analysis was level of hsCRP. Every 1 mg/L rise in hsCRP linked with a 15% increased rate of resistance.
Dr. Dillinger also reported these findings in a published article (Am. Heart J. 2012;164:600-6)
Dr. Dillinger had no disclosures. Dr. Angiolillo said that he has received honoraria from several drug and device companies including Bristol Myers Squibb, Sanofi-Aventis, Eli Lilly, and others. He has also received research grants from several companies
On Twitter @mitchelzoler
PARIS – Twice-daily dosing with aspirin worked substantially better for blocking platelet aggregation than did once-daily treatment with the same total dosage, in patients with diabetes and coronary artery disease in a single-center crossover study with 92 patients.
Patients with diabetes are often less responsive to aspirin treatment for secondary prevention of cardiovascular events than are patients without diabetes, apparently because of faster platelet turnover in patients with diabetes, Dr. Jean-Guillaume Dillinger said at the annual meeting of the European Association for Percutaneous Cardiovascular Interventions. Because aspirin levels sufficient to dampen platelet aggregation persist only for about 2 hours following a dose, faster platelet turnover leads to fewer platelets exposed to an adequate aspirin level, increased aspirin resistance, and greater thrombotic potential.
"The results of our study offer a new option to overcome biological aspirin resistance in patients with diabetes," said Dr. Dillinger, a cardiologist at Lariboisière Hospital in Paris. But Dr. Dillinger also cautioned that "large, prospective trials are needed to test if aspirin twice daily can decrease the rate of atherothrombotic events without increasing side effects such as gastrointestinal toxicity." Another potential drawback of twice-daily dosing is that patient compliance with the regimen may be reduced.
Dr. Dillinger also stressed that his study specifically enrolled patients with diabetes with at least one additional risk factor for loss of aspirin efficacy: They were either smokers or had elevated inflammatory markers, and hence, "the results cannot be extrapolated to the whole population of patients with diabetes and coronary artery disease." But he estimated that more than half of patients with diabetes and coronary artery disease (CAD) likely have at least one of these increased-risk factors.
"The results from Dr. Dillinger’s pharmacodynamic study show that a twice-daily regimen may offer greater antiplatelet effects than once daily and are in line with the results from prior investigations," commented Dr. Dominick J. Angiolillo, director of the Cardiovascular Research and Thrombosis Research Center at the University of Florida in Jacksonville. "The data support that [a twice-daily] regimen can be an effective strategy to improve response profiles, but this was a pharmacodynamic study and no conclusions can be made from the results on its clinical efficacy of safety. Clinical studies are warranted to support a change in practice," he said in an interview.
Dr. Dillinger and his associates enrolled 92 patients with diabetes and angiography-confirmed CAD who were already on aspirin treatment. All patients had been first diagnosed with diabetes after they were 30 years old, and they had not received insulin as their initial diabetes treatment unless their treatment had begun during an episode of acute coronary syndrome. In addition, all enrolled patients had at least one of these additional risk factors: current smoker, a high-sensitivity C-reaction protein (hsCRP) level of more than 4 mg/L, a fibrinogen level of more than 4 g/L, or a platelet count of more than 270,000/mm3.
The patients averaged 64 years old, 85% were men, and they entered the study an average of 12 years following their diabetes diagnosis. Of the 92 patients, 48% had one high-risk marker, 30% had two, 15% had three, and 7% had all four of the high-risk markers. Forty-eight (52%) of the patients entered the study on a daily clopidogrel regimen, and that treatment continued.
Patients were randomized to receive either 150 mg aspirin once daily taken every morning for 7-14 days before blood sampling, or 75 mg of aspirin taken twice daily, once in the morning and once in the evening for 7-14 days before their blood was drawn. Following the blood draw, they immediately switched to the alternative regimen that again continued for 7-14 days before the researchers took a second blood sample.
They assessed aspirin resistance by measuring platelet aggregation of each blood specimen using light transmission aggregometry. Specimens that produced a maximum aggregation intensity of at least 20% were considered to indicate aspirin resistance.
Testing revealed aspirin resistance in 39 (42%) patients when the study group received aspirin once daily, and in 16 patients (17%) when they were on the twice-daily regimen, a statistically significant difference.
When the 39 patients who showed aspirin resistance on the once-daily dosage were switched to twice-daily, 24 became aspirin responders on the twice-daily schedule. In contrast, among the 16 patients who were aspirin resistant on twice-daily treatment, 1 patient became responsive on the once-daily regimen, Dr. Dillinger reported.
The researchers also applied a second measure of platelet function – global platelet reactivity – using a platelet function analyzer. By this measure, they found that 38 (41%) of patients had normal platelet reactivity with once-daily aspirin, compared with 27 (29%) when patients were on twice-daily treatment. Within the subgroup of 27 patients who were resistant on either of the two regimens but not the other, 19 (70%) became responders when switched to the bid regimen, with 8 (30%) becoming responders when switched to once daily, a statistically significant difference between the two regimens.
Clopidogrel treatment had no discernable impact on the links between dosing frequency and aspirin’s antiplatelet effects.
A multivariate analysis of factors potentially affecting aspirin’s antiplatelet effect found that twice-daily treatment linked with a statistically significant 79% cut in the likelihood of aspirin resistance, compared with once daily. The only other parameter measured with a significant impact on aspirin resistance in this analysis was level of hsCRP. Every 1 mg/L rise in hsCRP linked with a 15% increased rate of resistance.
Dr. Dillinger also reported these findings in a published article (Am. Heart J. 2012;164:600-6)
Dr. Dillinger had no disclosures. Dr. Angiolillo said that he has received honoraria from several drug and device companies including Bristol Myers Squibb, Sanofi-Aventis, Eli Lilly, and others. He has also received research grants from several companies
On Twitter @mitchelzoler
PARIS – Twice-daily dosing with aspirin worked substantially better for blocking platelet aggregation than did once-daily treatment with the same total dosage, in patients with diabetes and coronary artery disease in a single-center crossover study with 92 patients.
Patients with diabetes are often less responsive to aspirin treatment for secondary prevention of cardiovascular events than are patients without diabetes, apparently because of faster platelet turnover in patients with diabetes, Dr. Jean-Guillaume Dillinger said at the annual meeting of the European Association for Percutaneous Cardiovascular Interventions. Because aspirin levels sufficient to dampen platelet aggregation persist only for about 2 hours following a dose, faster platelet turnover leads to fewer platelets exposed to an adequate aspirin level, increased aspirin resistance, and greater thrombotic potential.
"The results of our study offer a new option to overcome biological aspirin resistance in patients with diabetes," said Dr. Dillinger, a cardiologist at Lariboisière Hospital in Paris. But Dr. Dillinger also cautioned that "large, prospective trials are needed to test if aspirin twice daily can decrease the rate of atherothrombotic events without increasing side effects such as gastrointestinal toxicity." Another potential drawback of twice-daily dosing is that patient compliance with the regimen may be reduced.
Dr. Dillinger also stressed that his study specifically enrolled patients with diabetes with at least one additional risk factor for loss of aspirin efficacy: They were either smokers or had elevated inflammatory markers, and hence, "the results cannot be extrapolated to the whole population of patients with diabetes and coronary artery disease." But he estimated that more than half of patients with diabetes and coronary artery disease (CAD) likely have at least one of these increased-risk factors.
"The results from Dr. Dillinger’s pharmacodynamic study show that a twice-daily regimen may offer greater antiplatelet effects than once daily and are in line with the results from prior investigations," commented Dr. Dominick J. Angiolillo, director of the Cardiovascular Research and Thrombosis Research Center at the University of Florida in Jacksonville. "The data support that [a twice-daily] regimen can be an effective strategy to improve response profiles, but this was a pharmacodynamic study and no conclusions can be made from the results on its clinical efficacy of safety. Clinical studies are warranted to support a change in practice," he said in an interview.
Dr. Dillinger and his associates enrolled 92 patients with diabetes and angiography-confirmed CAD who were already on aspirin treatment. All patients had been first diagnosed with diabetes after they were 30 years old, and they had not received insulin as their initial diabetes treatment unless their treatment had begun during an episode of acute coronary syndrome. In addition, all enrolled patients had at least one of these additional risk factors: current smoker, a high-sensitivity C-reaction protein (hsCRP) level of more than 4 mg/L, a fibrinogen level of more than 4 g/L, or a platelet count of more than 270,000/mm3.
The patients averaged 64 years old, 85% were men, and they entered the study an average of 12 years following their diabetes diagnosis. Of the 92 patients, 48% had one high-risk marker, 30% had two, 15% had three, and 7% had all four of the high-risk markers. Forty-eight (52%) of the patients entered the study on a daily clopidogrel regimen, and that treatment continued.
Patients were randomized to receive either 150 mg aspirin once daily taken every morning for 7-14 days before blood sampling, or 75 mg of aspirin taken twice daily, once in the morning and once in the evening for 7-14 days before their blood was drawn. Following the blood draw, they immediately switched to the alternative regimen that again continued for 7-14 days before the researchers took a second blood sample.
They assessed aspirin resistance by measuring platelet aggregation of each blood specimen using light transmission aggregometry. Specimens that produced a maximum aggregation intensity of at least 20% were considered to indicate aspirin resistance.
Testing revealed aspirin resistance in 39 (42%) patients when the study group received aspirin once daily, and in 16 patients (17%) when they were on the twice-daily regimen, a statistically significant difference.
When the 39 patients who showed aspirin resistance on the once-daily dosage were switched to twice-daily, 24 became aspirin responders on the twice-daily schedule. In contrast, among the 16 patients who were aspirin resistant on twice-daily treatment, 1 patient became responsive on the once-daily regimen, Dr. Dillinger reported.
The researchers also applied a second measure of platelet function – global platelet reactivity – using a platelet function analyzer. By this measure, they found that 38 (41%) of patients had normal platelet reactivity with once-daily aspirin, compared with 27 (29%) when patients were on twice-daily treatment. Within the subgroup of 27 patients who were resistant on either of the two regimens but not the other, 19 (70%) became responders when switched to the bid regimen, with 8 (30%) becoming responders when switched to once daily, a statistically significant difference between the two regimens.
Clopidogrel treatment had no discernable impact on the links between dosing frequency and aspirin’s antiplatelet effects.
A multivariate analysis of factors potentially affecting aspirin’s antiplatelet effect found that twice-daily treatment linked with a statistically significant 79% cut in the likelihood of aspirin resistance, compared with once daily. The only other parameter measured with a significant impact on aspirin resistance in this analysis was level of hsCRP. Every 1 mg/L rise in hsCRP linked with a 15% increased rate of resistance.
Dr. Dillinger also reported these findings in a published article (Am. Heart J. 2012;164:600-6)
Dr. Dillinger had no disclosures. Dr. Angiolillo said that he has received honoraria from several drug and device companies including Bristol Myers Squibb, Sanofi-Aventis, Eli Lilly, and others. He has also received research grants from several companies
On Twitter @mitchelzoler
AT EUROPCR 2013
Major finding: Aspirin resistance occurred in 42% of patients receiving 150 mg aspirin once daily and in 17% on 75 mg twice daily.
Data source: A single-center crossover study of 92 patients with diabetes and coronary artery disease.
Disclosures: Dr. Dillinger had no disclosures. Dr. Angiolillo said that he has received honoraria from several drug and device companies including Bristol Myers Squibb, Sanofi-Aventis, Eli Lilly, and others. He has also received research grants from several companies.
Renal denervation benefits moderate-hypertension patients
PARIS – Renal denervation may help lower blood pressure in patients with moderate hypertension that is resistant to drug treatment, a study has shown.
In a pilot, uncontrolled study with 54 patients at one German center, renal denervation was safe and reasonably effective for patients with treatment-resistant hypertension and an average baseline blood pressure of 151/82 mm Hg.
The patients in the study had persistent office blood pressure measures of at least 140/90 mm Hg but less than 160/100 mm Hg, despite stable treatment with at least three antihypertensive drugs, including one diuretic. To enter the study, patients also needed 24-hour blood pressure monitoring showing consistent blood pressure levels of at least 130/80 mm Hg.
A total of 51% of the patients reached their target blood pressure of less than 140/90 mm Hg at 6 months after renal denervation treatment, Dr. Roland E. Schmieder said at the annual meeting of the European Association of Percutaneous Cardiovascular Intervention.
The percentage of patients reaching their goal pressure in the new study surpassed the outcome reported in the Symplicity HTN-2 trial, which showed that 39% of patients with severe treatment-resistant hypertension reached their goal pressure 6 months after renal denervation (Lancet 2010;376:1903-9).
Patients in the new study had their blood pressure fall by substantially less than in the Symplicity HTN-2 study, by an average of 12.5/7.5 mm Hg after 6 months in the new study, compared with 32/12 mm Hg in the renal denervation arm of Symplicity HTN-2. However, the smaller reduction was expected because patients in the new study entered treatment with much lower blood pressures than did patients in the older trial.
"The lower the starting blood pressure, the less the response" to renal denervation, explained Dr. Schmieder, professor and head of the clinical research center of hypertension and vascular medicine at University Hospital in Erlangen, Germany. Several years of study on the effect of renal denervation clearly established this relationship, he noted.
The new study enrolled patients with a mean age of 64 years who all underwent standard renal denervation treatment using the Symplicity Flex system. The procedures produced no complications, and in addition to reducing office blood pressure measurements, the treatment produced an average reduction in heart rate of 4 bpm after 6 months. The reported changes in blood pressure occurred even though 37% of the patients in the study reduced their antihypertensive treatment regimen, despite instructions from their physicians to continue their usual treatment dosages. Moreover, none of the patients received an increase in their hypertension treatment medications during follow-up, Dr. Schmieder said.
"Our data are encouraging" for using renal denervation to treat moderate treatment-resistant hypertension, he concluded. Researchers will soon start a multicenter, controlled study to more definitively assess the safety and efficacy of renal denervation in patients with resistant hypertension with systolic blood pressures of 140-159 mm Hg, Dr. Schmieder said.
The study received no commercial support. Dr. Schmieder said he has been a consultant to and has received research support from Medtronic, the company that markets the Symplicity renal denervation systems.
On Twitter @mitchelzoler
PARIS – Renal denervation may help lower blood pressure in patients with moderate hypertension that is resistant to drug treatment, a study has shown.
In a pilot, uncontrolled study with 54 patients at one German center, renal denervation was safe and reasonably effective for patients with treatment-resistant hypertension and an average baseline blood pressure of 151/82 mm Hg.
The patients in the study had persistent office blood pressure measures of at least 140/90 mm Hg but less than 160/100 mm Hg, despite stable treatment with at least three antihypertensive drugs, including one diuretic. To enter the study, patients also needed 24-hour blood pressure monitoring showing consistent blood pressure levels of at least 130/80 mm Hg.
A total of 51% of the patients reached their target blood pressure of less than 140/90 mm Hg at 6 months after renal denervation treatment, Dr. Roland E. Schmieder said at the annual meeting of the European Association of Percutaneous Cardiovascular Intervention.
The percentage of patients reaching their goal pressure in the new study surpassed the outcome reported in the Symplicity HTN-2 trial, which showed that 39% of patients with severe treatment-resistant hypertension reached their goal pressure 6 months after renal denervation (Lancet 2010;376:1903-9).
Patients in the new study had their blood pressure fall by substantially less than in the Symplicity HTN-2 study, by an average of 12.5/7.5 mm Hg after 6 months in the new study, compared with 32/12 mm Hg in the renal denervation arm of Symplicity HTN-2. However, the smaller reduction was expected because patients in the new study entered treatment with much lower blood pressures than did patients in the older trial.
"The lower the starting blood pressure, the less the response" to renal denervation, explained Dr. Schmieder, professor and head of the clinical research center of hypertension and vascular medicine at University Hospital in Erlangen, Germany. Several years of study on the effect of renal denervation clearly established this relationship, he noted.
The new study enrolled patients with a mean age of 64 years who all underwent standard renal denervation treatment using the Symplicity Flex system. The procedures produced no complications, and in addition to reducing office blood pressure measurements, the treatment produced an average reduction in heart rate of 4 bpm after 6 months. The reported changes in blood pressure occurred even though 37% of the patients in the study reduced their antihypertensive treatment regimen, despite instructions from their physicians to continue their usual treatment dosages. Moreover, none of the patients received an increase in their hypertension treatment medications during follow-up, Dr. Schmieder said.
"Our data are encouraging" for using renal denervation to treat moderate treatment-resistant hypertension, he concluded. Researchers will soon start a multicenter, controlled study to more definitively assess the safety and efficacy of renal denervation in patients with resistant hypertension with systolic blood pressures of 140-159 mm Hg, Dr. Schmieder said.
The study received no commercial support. Dr. Schmieder said he has been a consultant to and has received research support from Medtronic, the company that markets the Symplicity renal denervation systems.
On Twitter @mitchelzoler
PARIS – Renal denervation may help lower blood pressure in patients with moderate hypertension that is resistant to drug treatment, a study has shown.
In a pilot, uncontrolled study with 54 patients at one German center, renal denervation was safe and reasonably effective for patients with treatment-resistant hypertension and an average baseline blood pressure of 151/82 mm Hg.
The patients in the study had persistent office blood pressure measures of at least 140/90 mm Hg but less than 160/100 mm Hg, despite stable treatment with at least three antihypertensive drugs, including one diuretic. To enter the study, patients also needed 24-hour blood pressure monitoring showing consistent blood pressure levels of at least 130/80 mm Hg.
A total of 51% of the patients reached their target blood pressure of less than 140/90 mm Hg at 6 months after renal denervation treatment, Dr. Roland E. Schmieder said at the annual meeting of the European Association of Percutaneous Cardiovascular Intervention.
The percentage of patients reaching their goal pressure in the new study surpassed the outcome reported in the Symplicity HTN-2 trial, which showed that 39% of patients with severe treatment-resistant hypertension reached their goal pressure 6 months after renal denervation (Lancet 2010;376:1903-9).
Patients in the new study had their blood pressure fall by substantially less than in the Symplicity HTN-2 study, by an average of 12.5/7.5 mm Hg after 6 months in the new study, compared with 32/12 mm Hg in the renal denervation arm of Symplicity HTN-2. However, the smaller reduction was expected because patients in the new study entered treatment with much lower blood pressures than did patients in the older trial.
"The lower the starting blood pressure, the less the response" to renal denervation, explained Dr. Schmieder, professor and head of the clinical research center of hypertension and vascular medicine at University Hospital in Erlangen, Germany. Several years of study on the effect of renal denervation clearly established this relationship, he noted.
The new study enrolled patients with a mean age of 64 years who all underwent standard renal denervation treatment using the Symplicity Flex system. The procedures produced no complications, and in addition to reducing office blood pressure measurements, the treatment produced an average reduction in heart rate of 4 bpm after 6 months. The reported changes in blood pressure occurred even though 37% of the patients in the study reduced their antihypertensive treatment regimen, despite instructions from their physicians to continue their usual treatment dosages. Moreover, none of the patients received an increase in their hypertension treatment medications during follow-up, Dr. Schmieder said.
"Our data are encouraging" for using renal denervation to treat moderate treatment-resistant hypertension, he concluded. Researchers will soon start a multicenter, controlled study to more definitively assess the safety and efficacy of renal denervation in patients with resistant hypertension with systolic blood pressures of 140-159 mm Hg, Dr. Schmieder said.
The study received no commercial support. Dr. Schmieder said he has been a consultant to and has received research support from Medtronic, the company that markets the Symplicity renal denervation systems.
On Twitter @mitchelzoler
AT EUROPCR 2013
Major finding: Renal denervation led to attainment of goal blood pressure in 51% of patients with moderate, treatment-resistant hypertension.
Data source: A single-center uncontrolled study with 54 patients.
Disclosures: The study received no commercial support. Dr. Schmieder said he has been a consultant to and has received research support from Medtronic, the company that markets the Symplicity renal denervation systems.
New TAVR device cuts aortic regurgitation
PARIS – A next-generation system for transcatheter aortic valve replacement produced substantially less aortic regurgitation, compared with the historical performance of marketed, percutaneous valve-replacement systems in a pilot, multicenter, uncontrolled study with 60 patients.
At 30 days after transcatheter aortic valve replacement (TAVR) using the investigational Lotus valve system, 1 of 53 patients assessed had moderate aortic regurgitation and no patients had severe regurgitation, Dr. Ian T. Meredith said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions. In addition, 10 patients (19%) had mild regurgitation, 5 patients (9%) had trace regurgitation, and 37 patients, 70%, had no regurgitation.
By contrast, results from one of the most recent TAVR studies reported using the Sapien valve systems now on the worldwide market in more than 400 patients (the Placement of Aortic Transcatheter Valves [PARTNER] II cohort B trial) showed a roughly 20% incidence of severe or moderate aortic regurgitation 30 days after TAVR, with about 40% of patients having mild regurgitation and fewer than 20% of patients with no regurgitation.
Dr. Meredith attributed the superior regurgitation performance with the new device to a key feature of the Lotus valve, an adaptive seal around the valve that he likened to "cling wrap" that fills most or all of the small spaces around the valve after it’s placed. This produces a tight seal and prevents regurgitation, said Dr. Meredith, professor and director of MonasHeart at Monash University in Victoria, Australia.
The other major feature of the new valve is that it is easily retrievable after deployment, allowing operators to reposition it if needed following initial deployment. In the 60 cases reported by Dr. Meredith operators took advantage of the retrievable feature in 16 cases: 12 times to reposition the valve, and in 4 cases, they completely removed the first valve and replaced it with a different-size (the valves used in the study came in two different sizes).
The REPRISE (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System–Evaluation of Safety and Performance) II trial enrolled 60 patients with severe, calcific aortic stenosis at seven centers in Australia and France during October 2012-January 2013. The patients averaged 86 years of age, and their average Society of Thoracic Surgeons risk score was 6.4%. At baseline their average aortic valve gradient was 47.5 mm Hg.
Valves were placed successfully in all 60 patients. The study’s primary performance endpoint was to produce an average aortic valve gradient of 18 mm Hg or less measured 30 days after valve placement. Actual performance was an average aortic valve gradient of 11.3 mm Hg in 52 patients measured at 30 days. In addition, one patient died, two patients had a disabling stroke, three had a nondisabling stroke, and five had a life-threatening bleed. The overall 30-day safety composite-event rate was 19%.
Valve calcification is the main cause of regurgitation following TAVR, Dr. Meredith said in an interview. The calcium in the aortic annulus appears in various shapes and sizes and can be difficult to flatten so that a simple valve seal could still be subject to leaks. The adaptive seal of the Lotus valve is better able to stop leaks, he said.
The study was sponsored by Boston Scientific, which is developing the Lotus valve system. Dr. Meredith said that he has been a consultant to and has received honoraria from Boston Scientific and Medtronic.
On Twitter @mitchelzoler
PARIS – A next-generation system for transcatheter aortic valve replacement produced substantially less aortic regurgitation, compared with the historical performance of marketed, percutaneous valve-replacement systems in a pilot, multicenter, uncontrolled study with 60 patients.
At 30 days after transcatheter aortic valve replacement (TAVR) using the investigational Lotus valve system, 1 of 53 patients assessed had moderate aortic regurgitation and no patients had severe regurgitation, Dr. Ian T. Meredith said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions. In addition, 10 patients (19%) had mild regurgitation, 5 patients (9%) had trace regurgitation, and 37 patients, 70%, had no regurgitation.
By contrast, results from one of the most recent TAVR studies reported using the Sapien valve systems now on the worldwide market in more than 400 patients (the Placement of Aortic Transcatheter Valves [PARTNER] II cohort B trial) showed a roughly 20% incidence of severe or moderate aortic regurgitation 30 days after TAVR, with about 40% of patients having mild regurgitation and fewer than 20% of patients with no regurgitation.
Dr. Meredith attributed the superior regurgitation performance with the new device to a key feature of the Lotus valve, an adaptive seal around the valve that he likened to "cling wrap" that fills most or all of the small spaces around the valve after it’s placed. This produces a tight seal and prevents regurgitation, said Dr. Meredith, professor and director of MonasHeart at Monash University in Victoria, Australia.
The other major feature of the new valve is that it is easily retrievable after deployment, allowing operators to reposition it if needed following initial deployment. In the 60 cases reported by Dr. Meredith operators took advantage of the retrievable feature in 16 cases: 12 times to reposition the valve, and in 4 cases, they completely removed the first valve and replaced it with a different-size (the valves used in the study came in two different sizes).
The REPRISE (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System–Evaluation of Safety and Performance) II trial enrolled 60 patients with severe, calcific aortic stenosis at seven centers in Australia and France during October 2012-January 2013. The patients averaged 86 years of age, and their average Society of Thoracic Surgeons risk score was 6.4%. At baseline their average aortic valve gradient was 47.5 mm Hg.
Valves were placed successfully in all 60 patients. The study’s primary performance endpoint was to produce an average aortic valve gradient of 18 mm Hg or less measured 30 days after valve placement. Actual performance was an average aortic valve gradient of 11.3 mm Hg in 52 patients measured at 30 days. In addition, one patient died, two patients had a disabling stroke, three had a nondisabling stroke, and five had a life-threatening bleed. The overall 30-day safety composite-event rate was 19%.
Valve calcification is the main cause of regurgitation following TAVR, Dr. Meredith said in an interview. The calcium in the aortic annulus appears in various shapes and sizes and can be difficult to flatten so that a simple valve seal could still be subject to leaks. The adaptive seal of the Lotus valve is better able to stop leaks, he said.
The study was sponsored by Boston Scientific, which is developing the Lotus valve system. Dr. Meredith said that he has been a consultant to and has received honoraria from Boston Scientific and Medtronic.
On Twitter @mitchelzoler
PARIS – A next-generation system for transcatheter aortic valve replacement produced substantially less aortic regurgitation, compared with the historical performance of marketed, percutaneous valve-replacement systems in a pilot, multicenter, uncontrolled study with 60 patients.
At 30 days after transcatheter aortic valve replacement (TAVR) using the investigational Lotus valve system, 1 of 53 patients assessed had moderate aortic regurgitation and no patients had severe regurgitation, Dr. Ian T. Meredith said at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions. In addition, 10 patients (19%) had mild regurgitation, 5 patients (9%) had trace regurgitation, and 37 patients, 70%, had no regurgitation.
By contrast, results from one of the most recent TAVR studies reported using the Sapien valve systems now on the worldwide market in more than 400 patients (the Placement of Aortic Transcatheter Valves [PARTNER] II cohort B trial) showed a roughly 20% incidence of severe or moderate aortic regurgitation 30 days after TAVR, with about 40% of patients having mild regurgitation and fewer than 20% of patients with no regurgitation.
Dr. Meredith attributed the superior regurgitation performance with the new device to a key feature of the Lotus valve, an adaptive seal around the valve that he likened to "cling wrap" that fills most or all of the small spaces around the valve after it’s placed. This produces a tight seal and prevents regurgitation, said Dr. Meredith, professor and director of MonasHeart at Monash University in Victoria, Australia.
The other major feature of the new valve is that it is easily retrievable after deployment, allowing operators to reposition it if needed following initial deployment. In the 60 cases reported by Dr. Meredith operators took advantage of the retrievable feature in 16 cases: 12 times to reposition the valve, and in 4 cases, they completely removed the first valve and replaced it with a different-size (the valves used in the study came in two different sizes).
The REPRISE (Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Valve System–Evaluation of Safety and Performance) II trial enrolled 60 patients with severe, calcific aortic stenosis at seven centers in Australia and France during October 2012-January 2013. The patients averaged 86 years of age, and their average Society of Thoracic Surgeons risk score was 6.4%. At baseline their average aortic valve gradient was 47.5 mm Hg.
Valves were placed successfully in all 60 patients. The study’s primary performance endpoint was to produce an average aortic valve gradient of 18 mm Hg or less measured 30 days after valve placement. Actual performance was an average aortic valve gradient of 11.3 mm Hg in 52 patients measured at 30 days. In addition, one patient died, two patients had a disabling stroke, three had a nondisabling stroke, and five had a life-threatening bleed. The overall 30-day safety composite-event rate was 19%.
Valve calcification is the main cause of regurgitation following TAVR, Dr. Meredith said in an interview. The calcium in the aortic annulus appears in various shapes and sizes and can be difficult to flatten so that a simple valve seal could still be subject to leaks. The adaptive seal of the Lotus valve is better able to stop leaks, he said.
The study was sponsored by Boston Scientific, which is developing the Lotus valve system. Dr. Meredith said that he has been a consultant to and has received honoraria from Boston Scientific and Medtronic.
On Twitter @mitchelzoler
AT EUROPCR 2013
Major finding: The Lotus valve had a 79% rate of no or trace aortic-valve regurgitation 30 days after transcatheter aortic valve replacement.
Data source: An uncontrolled, multicenter study with 60 patients.
Disclosures: The study was sponsored by Boston Scientific, which is developing the Lotus valve system. Dr. Meredith said that he has been a consultant to and has received honoraria from Boston Scientific and Medtronic.
Weighing a TAVR outcome
Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?
That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.
Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.
But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.
Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.
But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.
Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.
Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?
That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.
Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.
But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.
Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.
But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.
Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.
Is mild aortic regurgitation following transcatheter aortic valve replacement okay, or do patients face an unacceptably high risk for death when their procedure has that outcome?
That’s a question dogging transcatheter aortic valve replacement (TAVR) right now that will only get answered as more patients undergo TAVR and follow-up times increase. But it is also a question that probably comes up almost every day in cath labs performing TAVR.
Last month during EuroPCR, I heard the wrap-up for a just-completed TAVR case. After the replacement valve was placed, the patient had mild aortic regurgitation, and a key decision of the case was whether or not to try to fiddle with the valve to improve on that. Given the valvular calcification and the frailty of the patient, the physicians in the lab as well as those on the panel in the hall uniformly agreed that stopping at mild regurgitation was the best option for this case.
But hearing that, I also recalled the comment in March from Dr. Friederich-Wilhelm Mohr when he was reporting the most recent results from the German national TAVR registry. Dr. Mohr looked at the outcomes of patients with mild regurgitation and concluded that "regurgitation matters, whether is it mild or severe." In the German 1-year outcome results from nearly 2,700 patients who underwent transvascular TAVR, those who emerged with mild aortic regurgitation had a 25% 1-year mortality rate, compared with a 21% rate among patients who had no regurgitation flowing TAVR, and compared with a 50% rate in the small number of patients who emerged from TAVR with severe regurgitation. Dr. Mohr did not say whether he applied statistical analysis to those 21% and 25% results to determine if it was a significant difference.
Back to the case, is that possible 4% absolute difference in 1-year mortality worth the risk of possible clinical complications that fiddling with the valve might cause and with no guarantee of getting an improved result? The interventionalists thought that in this patient, the answer was to leave well enough alone.
But in the bigger picture, the answer lies in better TAVR devices that produce higher rates of patients with no regurgitation. In the German registry using 2011 TAVR technology, 56% of the transvascular TAVR patients had mild aortic regurgitation after their procedure finished. Dr. Mohr said that rate was too high.
Also at EuroPCR was a report from Dr. Ian Meredith from Melbourne on 60 patients treated with a new TAVR system designed to allow easy repositioning of the valve. Also, surrounding the valve as it gets placed in the patient’s heart is a layer of something Dr. Meredith likened to cling wrap, to fill and seal the small crevices around the new valve. In 53 patients with 30-day follow-up, one patient (2%) had moderate regurgitation, 10 patients (19%) had mild regurgitation, 13 (25%) had trace regurgitation, and 29 (55%) had no regurgitation. If those rates hold up with wider and longer use, it would be an advance, though still room for further improvement. By comparison, typical reported rates using the approved Sapien TAVR device show 15% moderate or severe regurgitation at 30 days following TAVR, 45% mild, and less than 20% with none.
Pressure wire sharpens CAD diagnosis
PARIS – Pressure wire assessment of ischemia in patients with stable angina changed the management strategy for these patients 27% of the time compared with decisions based solely on coronary anatomy information from angiography, in a prospective, multicenter British study with 200 patients.
Basing management of patients with stable angina on an angiogram alone is a "flawed" strategy, Dr. Nick Curzen said at the annual congress of the European Association of Percutaneous Cardiovascular Intervention. "Management of patients would be improved by routine use of fractional flow reserve [FFR] assessment at the diagnostic stage," he said.
Dr. Curzen stressed that this was a pilot study, and said that he is now trying to gather the funding needed to start a large-scale randomized trial to compare management decisions made with angiography alone with those made by routine ischemia assessment using a pressure wire to measure FFR throughout the main coronary branches of patients with stable angina suspected to be of coronary origin. Another limitation of the current results is "we have no idea whether this approach will be cost effective," he said.
Although results from three prior studies – DEFER (J. Am Coll. Cardiol. 2007;49:2105-11), FAME (N. Engl. J. Med. 2009;360:213-24), and FAME 2 (N. Engl. J. Med. 2012;367:991-1001) – together established definitively that measuring FFR with a pressure wire benefited patients by allowing interventionalists to identify clinically important coronary stenoses during percutaneous coronary intervention (PCI), the new study moved the time of pressure wire use earlier in the course of patient management.
"We pushed the time for FFR back to the diagnostic stage, not during PCI itself," said Dr. Curzen, professor of interventional cardiology at the University Hospital in Southampton (England)."The limitation of prior studies is that they did not take into account the options of medical management or coronary artery bypass grafting."
"This is a very, very important study. So far, measurement of fractional flow reserve has only been in patients already committed to undergoing PCI. But these data suggest that adding a pressure wire assessment at the diagnostic stage is potentially disruptive for current practice, it could potentially be very important for allocating resources, it may reduce the need for noninvasive testing, and it may also improve outcomes. I’m a big believer in the importance of ischemia," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium.
"We now need results from a prospective study to establish a link between this approach and improved outcomes," Dr. Wijns added.
The RIPCORD (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?) study enrolled 200 stable angina patients at 10 British centers. All patients underwent diagnostic angiography, and then the cardiologists recorded their treatment recommendation based on the anatomic information only, choosing among medical treatment, PCI, coronary bypass surgery, or need for additional, noninvasive testing, usually an exercise stress test. While the patients remained in the catheterization laboratory, they underwent pressure wire assessment for ischemia. Those findings were presented to the cardiologist, who could then change the initially recommended treatment if necessary based on this additional information.
Taking the FFR information into account changed recommended management for 53 of the 200 patients (27%). The changes led to more aggressive management in some patients and less aggressive treatments for others. For example, among the 90 patients initially flagged for PCI on the basis of their coronary anatomy, the attending cardiologists changed their recommendations to medical management for 24 patients after they found that none of the coronary lesions in these 24 patients caused clinically significant ischemia. On the other hand, among the 72 patients initially slotted for medical management based on their angiogram, the cardiologists found 9 patients whom they realized needed revascularization with PCI (6 patients) or coronary surgery (3 patients), Dr. Curzen reported.
Another result from the FFR assessment was a sharp drop in the number of patients with ambiguous results who required further testing. The number of cases that the cardiologists felt needed further testing dropped from 15 after angiography alone to a single patient once the FFR results were also available.
The study’s secondary endpoint was the change in the number of coronaries identified within each patient with significant stenoses that required treatment. Adding in the FFR information changed this designation for 64 of the 200 patients (32%). For example, angiography identified 84 patients with single-vessel disease, but with the pressure wire results, 24 of these patients were downgraded to having no affected coronary arteries, 6 patients got upgraded to having two-vessel disease, and an additional patient was identified with significant left-main disease that had been missed by angiography.
The study received an unrestricted research grant from St. Jude, which markets a pressure wire (PressureWire). Dr. Curzen said he has been a speaker on behalf of, and a consultant to, St. Jude, but was not reimbursed for the current study. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but had no disclosures related to St. Jude.
On Twitter @mitchelzoler
PARIS – Pressure wire assessment of ischemia in patients with stable angina changed the management strategy for these patients 27% of the time compared with decisions based solely on coronary anatomy information from angiography, in a prospective, multicenter British study with 200 patients.
Basing management of patients with stable angina on an angiogram alone is a "flawed" strategy, Dr. Nick Curzen said at the annual congress of the European Association of Percutaneous Cardiovascular Intervention. "Management of patients would be improved by routine use of fractional flow reserve [FFR] assessment at the diagnostic stage," he said.
Dr. Curzen stressed that this was a pilot study, and said that he is now trying to gather the funding needed to start a large-scale randomized trial to compare management decisions made with angiography alone with those made by routine ischemia assessment using a pressure wire to measure FFR throughout the main coronary branches of patients with stable angina suspected to be of coronary origin. Another limitation of the current results is "we have no idea whether this approach will be cost effective," he said.
Although results from three prior studies – DEFER (J. Am Coll. Cardiol. 2007;49:2105-11), FAME (N. Engl. J. Med. 2009;360:213-24), and FAME 2 (N. Engl. J. Med. 2012;367:991-1001) – together established definitively that measuring FFR with a pressure wire benefited patients by allowing interventionalists to identify clinically important coronary stenoses during percutaneous coronary intervention (PCI), the new study moved the time of pressure wire use earlier in the course of patient management.
"We pushed the time for FFR back to the diagnostic stage, not during PCI itself," said Dr. Curzen, professor of interventional cardiology at the University Hospital in Southampton (England)."The limitation of prior studies is that they did not take into account the options of medical management or coronary artery bypass grafting."
"This is a very, very important study. So far, measurement of fractional flow reserve has only been in patients already committed to undergoing PCI. But these data suggest that adding a pressure wire assessment at the diagnostic stage is potentially disruptive for current practice, it could potentially be very important for allocating resources, it may reduce the need for noninvasive testing, and it may also improve outcomes. I’m a big believer in the importance of ischemia," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium.
"We now need results from a prospective study to establish a link between this approach and improved outcomes," Dr. Wijns added.
The RIPCORD (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?) study enrolled 200 stable angina patients at 10 British centers. All patients underwent diagnostic angiography, and then the cardiologists recorded their treatment recommendation based on the anatomic information only, choosing among medical treatment, PCI, coronary bypass surgery, or need for additional, noninvasive testing, usually an exercise stress test. While the patients remained in the catheterization laboratory, they underwent pressure wire assessment for ischemia. Those findings were presented to the cardiologist, who could then change the initially recommended treatment if necessary based on this additional information.
Taking the FFR information into account changed recommended management for 53 of the 200 patients (27%). The changes led to more aggressive management in some patients and less aggressive treatments for others. For example, among the 90 patients initially flagged for PCI on the basis of their coronary anatomy, the attending cardiologists changed their recommendations to medical management for 24 patients after they found that none of the coronary lesions in these 24 patients caused clinically significant ischemia. On the other hand, among the 72 patients initially slotted for medical management based on their angiogram, the cardiologists found 9 patients whom they realized needed revascularization with PCI (6 patients) or coronary surgery (3 patients), Dr. Curzen reported.
Another result from the FFR assessment was a sharp drop in the number of patients with ambiguous results who required further testing. The number of cases that the cardiologists felt needed further testing dropped from 15 after angiography alone to a single patient once the FFR results were also available.
The study’s secondary endpoint was the change in the number of coronaries identified within each patient with significant stenoses that required treatment. Adding in the FFR information changed this designation for 64 of the 200 patients (32%). For example, angiography identified 84 patients with single-vessel disease, but with the pressure wire results, 24 of these patients were downgraded to having no affected coronary arteries, 6 patients got upgraded to having two-vessel disease, and an additional patient was identified with significant left-main disease that had been missed by angiography.
The study received an unrestricted research grant from St. Jude, which markets a pressure wire (PressureWire). Dr. Curzen said he has been a speaker on behalf of, and a consultant to, St. Jude, but was not reimbursed for the current study. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but had no disclosures related to St. Jude.
On Twitter @mitchelzoler
PARIS – Pressure wire assessment of ischemia in patients with stable angina changed the management strategy for these patients 27% of the time compared with decisions based solely on coronary anatomy information from angiography, in a prospective, multicenter British study with 200 patients.
Basing management of patients with stable angina on an angiogram alone is a "flawed" strategy, Dr. Nick Curzen said at the annual congress of the European Association of Percutaneous Cardiovascular Intervention. "Management of patients would be improved by routine use of fractional flow reserve [FFR] assessment at the diagnostic stage," he said.
Dr. Curzen stressed that this was a pilot study, and said that he is now trying to gather the funding needed to start a large-scale randomized trial to compare management decisions made with angiography alone with those made by routine ischemia assessment using a pressure wire to measure FFR throughout the main coronary branches of patients with stable angina suspected to be of coronary origin. Another limitation of the current results is "we have no idea whether this approach will be cost effective," he said.
Although results from three prior studies – DEFER (J. Am Coll. Cardiol. 2007;49:2105-11), FAME (N. Engl. J. Med. 2009;360:213-24), and FAME 2 (N. Engl. J. Med. 2012;367:991-1001) – together established definitively that measuring FFR with a pressure wire benefited patients by allowing interventionalists to identify clinically important coronary stenoses during percutaneous coronary intervention (PCI), the new study moved the time of pressure wire use earlier in the course of patient management.
"We pushed the time for FFR back to the diagnostic stage, not during PCI itself," said Dr. Curzen, professor of interventional cardiology at the University Hospital in Southampton (England)."The limitation of prior studies is that they did not take into account the options of medical management or coronary artery bypass grafting."
"This is a very, very important study. So far, measurement of fractional flow reserve has only been in patients already committed to undergoing PCI. But these data suggest that adding a pressure wire assessment at the diagnostic stage is potentially disruptive for current practice, it could potentially be very important for allocating resources, it may reduce the need for noninvasive testing, and it may also improve outcomes. I’m a big believer in the importance of ischemia," commented Dr. William Wijns, codirector of the cardiovascular center at OLV Hospital in Aalst, Belgium.
"We now need results from a prospective study to establish a link between this approach and improved outcomes," Dr. Wijns added.
The RIPCORD (Does Routine Pressure Wire Assessment Influence Management Strategy at Coronary Angiography for Diagnosis of Chest Pain?) study enrolled 200 stable angina patients at 10 British centers. All patients underwent diagnostic angiography, and then the cardiologists recorded their treatment recommendation based on the anatomic information only, choosing among medical treatment, PCI, coronary bypass surgery, or need for additional, noninvasive testing, usually an exercise stress test. While the patients remained in the catheterization laboratory, they underwent pressure wire assessment for ischemia. Those findings were presented to the cardiologist, who could then change the initially recommended treatment if necessary based on this additional information.
Taking the FFR information into account changed recommended management for 53 of the 200 patients (27%). The changes led to more aggressive management in some patients and less aggressive treatments for others. For example, among the 90 patients initially flagged for PCI on the basis of their coronary anatomy, the attending cardiologists changed their recommendations to medical management for 24 patients after they found that none of the coronary lesions in these 24 patients caused clinically significant ischemia. On the other hand, among the 72 patients initially slotted for medical management based on their angiogram, the cardiologists found 9 patients whom they realized needed revascularization with PCI (6 patients) or coronary surgery (3 patients), Dr. Curzen reported.
Another result from the FFR assessment was a sharp drop in the number of patients with ambiguous results who required further testing. The number of cases that the cardiologists felt needed further testing dropped from 15 after angiography alone to a single patient once the FFR results were also available.
The study’s secondary endpoint was the change in the number of coronaries identified within each patient with significant stenoses that required treatment. Adding in the FFR information changed this designation for 64 of the 200 patients (32%). For example, angiography identified 84 patients with single-vessel disease, but with the pressure wire results, 24 of these patients were downgraded to having no affected coronary arteries, 6 patients got upgraded to having two-vessel disease, and an additional patient was identified with significant left-main disease that had been missed by angiography.
The study received an unrestricted research grant from St. Jude, which markets a pressure wire (PressureWire). Dr. Curzen said he has been a speaker on behalf of, and a consultant to, St. Jude, but was not reimbursed for the current study. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but had no disclosures related to St. Jude.
On Twitter @mitchelzoler
AT EUROPCR 2013
Major finding: Adding a pressure wire assessment to angiography for coronary disease diagnosis changed management decisions in 27% of patients.
Data source: RIPCORD, a multicenter British study of 200 patients with stable angina referred for coronary artery assessment.
Disclosures: The study received an unrestricted research grant from St. Jude, which markets a pressure wire (PressureWire). Dr. Curzen said he has been a speaker on behalf of, and a consultant to, St. Jude, but was not reimbursed for the current study. Dr. Wijns said he has received honoraria and research grants from several drug and device companies, but had no disclosures related to St. Jude.
Swedish NSTEMI registry suggests comparability of heparin, bivalirudin
PARIS – Heparin treatment may produce survival rates that rival those seen in treatment with bivalirudin in patients with non–ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention, based on analysis of data from more than 40,000 patients collected in a nationwide Swedish registry.
The new finding “questions the superiority of bivalirudin over heparin in the absence of glycoprotein IIb/IIIa blockade” in these patients and produced some doubt about the need for the extra expense of using bivalirudin (Angiomax) to treat these patients, Dr. Oskar Angerås said at the annual meeting of the European Association of Percutaneous Coronary Interventions. The finding prompted him recently to shift his practice and treat non–ST-elevation acute coronary syndrome (NSTE-ACS) with heparin rather than bivalirudin when performing percutaneous coronary intervention (PCI), he said in an interview. It also led him and his associates to plan to soon start a randomized, controlled trial to compare the two treatment options in about 6,000 Swedish patients, a study he hopes will definitely address this issue.
Bivalirudin was the highest-rated anticoagulant for use during PCI in the most recent, 2011 guidelines of American College of Cardiology and American Heart Association (J. Am. Coll. Cardiol. 2011;58:e44-e122), while the European Society of Cardiology’s most recent guidelines on managing patients with NTSE-ACS rated fondaparinux (Arixtra) as the top anticoagulant and put bivalirudin, unfractionated heparin, and low-molecular-weight heparin on equal footing a step below fondaparinux (Eur. Heart J. 2011;32:2999-305zz4).
The role of bivalirudin in this setting largely stems from results of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial (N. Engl. J. Med. 2006;355:2203-16), but the trial has reduced relevance today because of several changes in practice since then, said Dr. Angerås , an interventional cardiologist at Sahlgrenska University Hospital in Gothenburg, Sweden. In ACUITY, all patients received a glycoprotein IIb/IIIa inhibitor, a drug class now infrequently used in these patients. Fewer than 60% of ACUITY patients underwent PCI, fewer than 60% were biomarker positive, and among those who did receive a coronary stent only 6% had their intervention done via radial-artery access, “quite different from our daily practice” today, he said.
Two other published studies also compared bivalirudin and heparin, the Hirulog Angioplasty Study (N. Engl. J. Med. 1995;333:764-9), and the Intracoronary Stenting and Antithrombosis Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 3 trial (N. Engl. J. Med. 2008;359:688-96), but both of those studies only found a difference in bleeding complications in favor of bivalirudin, but no mortality difference between the drugs, he noted.
To assess the impact of the two alternatives on patient survival in more contemporary practice, Dr. Angerås and his associates 41,537 consecutive NSTE-ACS patients who underwent PCI without use of a glycoprotein IIb/IIIa inhibitor at any of the 28 Swedish centers that participate in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2006-2011. The patients averaged about 68 years of age, about 75% were biomarker positive, and about 47% underwent PCI using a radial-artery approach. Nearly 27,000 of these patients received heparin, either in the unfractionated or low-molecular weight form, and about 8,700 received bivalirudin. Data on anticoagulant use were not available for about 6,000 patients.
Among the roughly 35,000 patients with known anticoagulant treatment, those who received bivalirudin had a statistically significant 50% increased 30-day mortality rate, compared with those who receive heparin. After the researchers did a series of statistical adjustments to control for both known and unknown confounders, the mortality rates in the heparin and bivalirudin subgroups became roughly similar, without a statistically significant difference, Dr. Angerås reported. The researchers saw similar mortality rates, regardless of the anticoagulant used; the patient’s age, sex, PCI access site; or the presence or absence of diabetes. The registry data also showed no statistically significant difference in bleeding episodes between the heparin- and bivalirudin-treated patients, but Dr. Angerås said that information on bleeding was not available for all of the years included in the analysis.
Patients who receive heparin and bivalirudin “are two different groups,” commented Dr. Andreas Baumbach, an interventional cardiologist at the Bristol (England) Heart Institute and designated discussant for the study. “It’s no surprise to me that in the group that I would consider to have higher risk,” the patients who received bivalirudin “had more endpoints. When you do all the statistical analysis and make the two groups equal by risk, then you see no difference.”
Dr. Angerås agreed. “We are very cautious about our conclusion,” and he stressed that the issue will not be clearly settled until results from the randomized, controlled study are available.
He also said that he found the result surprising, especially because until recently bivalirudin had been his anticoagulant of choice. Now that he has switched to more routinely using heparin, he has channeled the money he saves on each case into more liberal use of drug-eluting coronary stents in these patients. “Our drug-eluting stent use has risen from about 30% of patients to about 80%,” Dr. Angerås said in an interview. He also acknowledged that bleeding is not a benign complication, but added that bleeding is a surrogate endpoint with less clinical importance if it doesn’t produce increased mortality, and that in the data he reported bleeding rates were roughly equal between the bivalirudin and heparin subgroups.
Dr. Angerås said that he had no disclosures. Dr. Baumbach said that he has received research support from the Medicines Company, which markets bivalirudin (Angiomax).
PARIS – Heparin treatment may produce survival rates that rival those seen in treatment with bivalirudin in patients with non–ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention, based on analysis of data from more than 40,000 patients collected in a nationwide Swedish registry.
The new finding “questions the superiority of bivalirudin over heparin in the absence of glycoprotein IIb/IIIa blockade” in these patients and produced some doubt about the need for the extra expense of using bivalirudin (Angiomax) to treat these patients, Dr. Oskar Angerås said at the annual meeting of the European Association of Percutaneous Coronary Interventions. The finding prompted him recently to shift his practice and treat non–ST-elevation acute coronary syndrome (NSTE-ACS) with heparin rather than bivalirudin when performing percutaneous coronary intervention (PCI), he said in an interview. It also led him and his associates to plan to soon start a randomized, controlled trial to compare the two treatment options in about 6,000 Swedish patients, a study he hopes will definitely address this issue.
Bivalirudin was the highest-rated anticoagulant for use during PCI in the most recent, 2011 guidelines of American College of Cardiology and American Heart Association (J. Am. Coll. Cardiol. 2011;58:e44-e122), while the European Society of Cardiology’s most recent guidelines on managing patients with NTSE-ACS rated fondaparinux (Arixtra) as the top anticoagulant and put bivalirudin, unfractionated heparin, and low-molecular-weight heparin on equal footing a step below fondaparinux (Eur. Heart J. 2011;32:2999-305zz4).
The role of bivalirudin in this setting largely stems from results of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial (N. Engl. J. Med. 2006;355:2203-16), but the trial has reduced relevance today because of several changes in practice since then, said Dr. Angerås , an interventional cardiologist at Sahlgrenska University Hospital in Gothenburg, Sweden. In ACUITY, all patients received a glycoprotein IIb/IIIa inhibitor, a drug class now infrequently used in these patients. Fewer than 60% of ACUITY patients underwent PCI, fewer than 60% were biomarker positive, and among those who did receive a coronary stent only 6% had their intervention done via radial-artery access, “quite different from our daily practice” today, he said.
Two other published studies also compared bivalirudin and heparin, the Hirulog Angioplasty Study (N. Engl. J. Med. 1995;333:764-9), and the Intracoronary Stenting and Antithrombosis Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 3 trial (N. Engl. J. Med. 2008;359:688-96), but both of those studies only found a difference in bleeding complications in favor of bivalirudin, but no mortality difference between the drugs, he noted.
To assess the impact of the two alternatives on patient survival in more contemporary practice, Dr. Angerås and his associates 41,537 consecutive NSTE-ACS patients who underwent PCI without use of a glycoprotein IIb/IIIa inhibitor at any of the 28 Swedish centers that participate in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2006-2011. The patients averaged about 68 years of age, about 75% were biomarker positive, and about 47% underwent PCI using a radial-artery approach. Nearly 27,000 of these patients received heparin, either in the unfractionated or low-molecular weight form, and about 8,700 received bivalirudin. Data on anticoagulant use were not available for about 6,000 patients.
Among the roughly 35,000 patients with known anticoagulant treatment, those who received bivalirudin had a statistically significant 50% increased 30-day mortality rate, compared with those who receive heparin. After the researchers did a series of statistical adjustments to control for both known and unknown confounders, the mortality rates in the heparin and bivalirudin subgroups became roughly similar, without a statistically significant difference, Dr. Angerås reported. The researchers saw similar mortality rates, regardless of the anticoagulant used; the patient’s age, sex, PCI access site; or the presence or absence of diabetes. The registry data also showed no statistically significant difference in bleeding episodes between the heparin- and bivalirudin-treated patients, but Dr. Angerås said that information on bleeding was not available for all of the years included in the analysis.
Patients who receive heparin and bivalirudin “are two different groups,” commented Dr. Andreas Baumbach, an interventional cardiologist at the Bristol (England) Heart Institute and designated discussant for the study. “It’s no surprise to me that in the group that I would consider to have higher risk,” the patients who received bivalirudin “had more endpoints. When you do all the statistical analysis and make the two groups equal by risk, then you see no difference.”
Dr. Angerås agreed. “We are very cautious about our conclusion,” and he stressed that the issue will not be clearly settled until results from the randomized, controlled study are available.
He also said that he found the result surprising, especially because until recently bivalirudin had been his anticoagulant of choice. Now that he has switched to more routinely using heparin, he has channeled the money he saves on each case into more liberal use of drug-eluting coronary stents in these patients. “Our drug-eluting stent use has risen from about 30% of patients to about 80%,” Dr. Angerås said in an interview. He also acknowledged that bleeding is not a benign complication, but added that bleeding is a surrogate endpoint with less clinical importance if it doesn’t produce increased mortality, and that in the data he reported bleeding rates were roughly equal between the bivalirudin and heparin subgroups.
Dr. Angerås said that he had no disclosures. Dr. Baumbach said that he has received research support from the Medicines Company, which markets bivalirudin (Angiomax).
PARIS – Heparin treatment may produce survival rates that rival those seen in treatment with bivalirudin in patients with non–ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention, based on analysis of data from more than 40,000 patients collected in a nationwide Swedish registry.
The new finding “questions the superiority of bivalirudin over heparin in the absence of glycoprotein IIb/IIIa blockade” in these patients and produced some doubt about the need for the extra expense of using bivalirudin (Angiomax) to treat these patients, Dr. Oskar Angerås said at the annual meeting of the European Association of Percutaneous Coronary Interventions. The finding prompted him recently to shift his practice and treat non–ST-elevation acute coronary syndrome (NSTE-ACS) with heparin rather than bivalirudin when performing percutaneous coronary intervention (PCI), he said in an interview. It also led him and his associates to plan to soon start a randomized, controlled trial to compare the two treatment options in about 6,000 Swedish patients, a study he hopes will definitely address this issue.
Bivalirudin was the highest-rated anticoagulant for use during PCI in the most recent, 2011 guidelines of American College of Cardiology and American Heart Association (J. Am. Coll. Cardiol. 2011;58:e44-e122), while the European Society of Cardiology’s most recent guidelines on managing patients with NTSE-ACS rated fondaparinux (Arixtra) as the top anticoagulant and put bivalirudin, unfractionated heparin, and low-molecular-weight heparin on equal footing a step below fondaparinux (Eur. Heart J. 2011;32:2999-305zz4).
The role of bivalirudin in this setting largely stems from results of the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial (N. Engl. J. Med. 2006;355:2203-16), but the trial has reduced relevance today because of several changes in practice since then, said Dr. Angerås , an interventional cardiologist at Sahlgrenska University Hospital in Gothenburg, Sweden. In ACUITY, all patients received a glycoprotein IIb/IIIa inhibitor, a drug class now infrequently used in these patients. Fewer than 60% of ACUITY patients underwent PCI, fewer than 60% were biomarker positive, and among those who did receive a coronary stent only 6% had their intervention done via radial-artery access, “quite different from our daily practice” today, he said.
Two other published studies also compared bivalirudin and heparin, the Hirulog Angioplasty Study (N. Engl. J. Med. 1995;333:764-9), and the Intracoronary Stenting and Antithrombosis Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 3 trial (N. Engl. J. Med. 2008;359:688-96), but both of those studies only found a difference in bleeding complications in favor of bivalirudin, but no mortality difference between the drugs, he noted.
To assess the impact of the two alternatives on patient survival in more contemporary practice, Dr. Angerås and his associates 41,537 consecutive NSTE-ACS patients who underwent PCI without use of a glycoprotein IIb/IIIa inhibitor at any of the 28 Swedish centers that participate in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) during 2006-2011. The patients averaged about 68 years of age, about 75% were biomarker positive, and about 47% underwent PCI using a radial-artery approach. Nearly 27,000 of these patients received heparin, either in the unfractionated or low-molecular weight form, and about 8,700 received bivalirudin. Data on anticoagulant use were not available for about 6,000 patients.
Among the roughly 35,000 patients with known anticoagulant treatment, those who received bivalirudin had a statistically significant 50% increased 30-day mortality rate, compared with those who receive heparin. After the researchers did a series of statistical adjustments to control for both known and unknown confounders, the mortality rates in the heparin and bivalirudin subgroups became roughly similar, without a statistically significant difference, Dr. Angerås reported. The researchers saw similar mortality rates, regardless of the anticoagulant used; the patient’s age, sex, PCI access site; or the presence or absence of diabetes. The registry data also showed no statistically significant difference in bleeding episodes between the heparin- and bivalirudin-treated patients, but Dr. Angerås said that information on bleeding was not available for all of the years included in the analysis.
Patients who receive heparin and bivalirudin “are two different groups,” commented Dr. Andreas Baumbach, an interventional cardiologist at the Bristol (England) Heart Institute and designated discussant for the study. “It’s no surprise to me that in the group that I would consider to have higher risk,” the patients who received bivalirudin “had more endpoints. When you do all the statistical analysis and make the two groups equal by risk, then you see no difference.”
Dr. Angerås agreed. “We are very cautious about our conclusion,” and he stressed that the issue will not be clearly settled until results from the randomized, controlled study are available.
He also said that he found the result surprising, especially because until recently bivalirudin had been his anticoagulant of choice. Now that he has switched to more routinely using heparin, he has channeled the money he saves on each case into more liberal use of drug-eluting coronary stents in these patients. “Our drug-eluting stent use has risen from about 30% of patients to about 80%,” Dr. Angerås said in an interview. He also acknowledged that bleeding is not a benign complication, but added that bleeding is a surrogate endpoint with less clinical importance if it doesn’t produce increased mortality, and that in the data he reported bleeding rates were roughly equal between the bivalirudin and heparin subgroups.
Dr. Angerås said that he had no disclosures. Dr. Baumbach said that he has received research support from the Medicines Company, which markets bivalirudin (Angiomax).
AT EUROPCR 2013
Major finding:NSTE-ACS patients treated with heparin or bivalirudin had similar 30-day
mortality rates following PCI.
Data source: An
analysis of 41,537 patients with non–ST-elevation acute coronary syndrome who
underwent PCI without treatment with a glycoprotein IIb/IIIa inhibitor during
2006-2011 at any of 28 Swedish centers and were enrolled in the Swedish
Coronary Angiography and Angioplasty Registry.
Disclosures:
Dr. Angerås said that he had no disclosures. Dr. Baumbach said that he has
received research support from The Medicines Company, which markets
bivalirudin.
