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CT renders transesophageal echo largely avoidable in TAVR
PARIS – Advances in CT scanner technology make cardiac CT a viable alternative to transesophageal echocardiography for preprocedural detection of left atrial appendage thrombus in candidates for transcatheter aortic valve replacement, Dr. Paul D. Williams said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
This strategy helps simplify transcatheter aortic valve replacement (TAVR). That has become a major goal for the field now that TAVR’s safety and effectiveness have been established, said Dr. Williams of James Cook University Hospital in Middlesbrough, England.
“With the use of CT as the preferred method for annular sizing prior to the procedure and the increasing use of conscious sedation, transesophageal echo can be avoided altogether in many patients. And identification of left atrial appendage thrombus [LAAT] on CT may lead to changes in management, including optimization of oral anticoagulation, the use of an embolic protection device, and possibly obtaining consent from patients for a higher risk of procedural stroke,” he added.
Transesophageal echocardiography (TEE) has long been considered the gold standard method for detecting LAAT. But it has several disadvantages: It’s invasive, requires heavy sedation, and poses a small risk of serious complications.
Dr. Williams presented a single-center prospective study involving 198 consecutive patients who underwent dual source CT scanning with retrospective gated acquisition and flash angiographic acquisition during their pre-TAVR workup. The study showed that atrial fibrillation (AF) is very common in TAVR candidates, that LAAT is far more common in the TAVR population with AF than in the general AF population, and that while TAVR can still be performed in patients with LAAT, the periprocedural stroke risk appears to be higher.
Of the 198 TAVR candidates, 32% had AF. Two independent cardiologists with CT expertise rated 11.1% of TAVR candidates as having definite LAAT on the basis of a filling defect in both phases of imaging. Another 83.8% were deemed to definitely not have LAAT, while in 5.1% of cases the CT image quality wasn’t sufficient to render a judgment.
“The literature would suggest only about 5% of patients in the general AF population have LAAT. The rate is much higher in a TAVR population,” the cardiologist observed.
As expected, AF was a strong predictor of LAAT being found on CT, with a 32% prevalence in the AF subgroup, compared with just 1.6% in patients without AF.
Ninety-eight patients with a diagnostic CT also had a TEE. Six of the eight with LAAT on CT also showed LAAT on TEE. Two patients had LAAT on CT but not TEE. Thus, CT had 100% sensitivity, 97.8% specificity, a 75% positive predictive value, and a 100% negative predictive value, Dr. Williams continued.
Of the 198 patients evaluated by CT, 124 actually underwent TAVR. AF was present in 34% of these patients, whose mean CHA2DS2-VASc score was 3.7. CT showed that 8.1% of the patients who had TAVR had definite LAAT, and 84.7% definitely did not.
Six of the 124 patients (4.8%) had a stroke during their hospital stay for TAVR. Two of the six had LAAT on their preprocedural CT; both were being anticoagulated with warfarin at the time. The other four patients with periprocedural stroke didn’t have AF, were negative for LAAT on preprocedural CT, and weren’t being anticoagulated.
“Importantly, in the overall TAVR cohort, 8 of the 10 patients with LAAT on CT did not have a clinically evident periprocedural stroke,” Dr. Williams noted.
Session chair Dr. Rajendra Makkar, director of interventional cardiology at the Cedars-Sinai Heart Institute in Los Angeles, commented, “Your study has very, very important implications for how we actually change the management of some of our patients. You’ve shown LAAT is much more important in TAVR patients than I’d thought. A stroke risk of 20% with LAAT versus 3.8% in patients without LAAT is an impressive difference.”
His take away lesson from the study, Dr. Makkar added, is that if a patient has a preprocedural CT scan that’s negative for LAAT, there’s no need to do a TEE. If CT is positive or nondefinitive, it makes sense to review the patient’s anticoagulation regimen, then bring the patient back a few weeks later for a TEE to see if the LAAT has resolved.
Dr. Williams replied that’s exactly the practice now being followed at his hospital. If CT shows LAAT in a patient with AF who’s already on warfarin, physicians will consider aiming for a higher target INR [international normalized ratio], or they’ll switch to one of the novel oral anticoagulants if there’s a warfarin compliance issue. Then they’ll bring the patient back for a TEE.
“If the TEE is positive for LAAT we will still offer them TAVR, with the use of an embolic protection device if the anatomy is suitable, but we will tell them that potentially they may be at higher risk of stroke,” Dr. Williams said.
He reported having no financial conflicts of interest regarding this study.
PARIS – Advances in CT scanner technology make cardiac CT a viable alternative to transesophageal echocardiography for preprocedural detection of left atrial appendage thrombus in candidates for transcatheter aortic valve replacement, Dr. Paul D. Williams said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
This strategy helps simplify transcatheter aortic valve replacement (TAVR). That has become a major goal for the field now that TAVR’s safety and effectiveness have been established, said Dr. Williams of James Cook University Hospital in Middlesbrough, England.
“With the use of CT as the preferred method for annular sizing prior to the procedure and the increasing use of conscious sedation, transesophageal echo can be avoided altogether in many patients. And identification of left atrial appendage thrombus [LAAT] on CT may lead to changes in management, including optimization of oral anticoagulation, the use of an embolic protection device, and possibly obtaining consent from patients for a higher risk of procedural stroke,” he added.
Transesophageal echocardiography (TEE) has long been considered the gold standard method for detecting LAAT. But it has several disadvantages: It’s invasive, requires heavy sedation, and poses a small risk of serious complications.
Dr. Williams presented a single-center prospective study involving 198 consecutive patients who underwent dual source CT scanning with retrospective gated acquisition and flash angiographic acquisition during their pre-TAVR workup. The study showed that atrial fibrillation (AF) is very common in TAVR candidates, that LAAT is far more common in the TAVR population with AF than in the general AF population, and that while TAVR can still be performed in patients with LAAT, the periprocedural stroke risk appears to be higher.
Of the 198 TAVR candidates, 32% had AF. Two independent cardiologists with CT expertise rated 11.1% of TAVR candidates as having definite LAAT on the basis of a filling defect in both phases of imaging. Another 83.8% were deemed to definitely not have LAAT, while in 5.1% of cases the CT image quality wasn’t sufficient to render a judgment.
“The literature would suggest only about 5% of patients in the general AF population have LAAT. The rate is much higher in a TAVR population,” the cardiologist observed.
As expected, AF was a strong predictor of LAAT being found on CT, with a 32% prevalence in the AF subgroup, compared with just 1.6% in patients without AF.
Ninety-eight patients with a diagnostic CT also had a TEE. Six of the eight with LAAT on CT also showed LAAT on TEE. Two patients had LAAT on CT but not TEE. Thus, CT had 100% sensitivity, 97.8% specificity, a 75% positive predictive value, and a 100% negative predictive value, Dr. Williams continued.
Of the 198 patients evaluated by CT, 124 actually underwent TAVR. AF was present in 34% of these patients, whose mean CHA2DS2-VASc score was 3.7. CT showed that 8.1% of the patients who had TAVR had definite LAAT, and 84.7% definitely did not.
Six of the 124 patients (4.8%) had a stroke during their hospital stay for TAVR. Two of the six had LAAT on their preprocedural CT; both were being anticoagulated with warfarin at the time. The other four patients with periprocedural stroke didn’t have AF, were negative for LAAT on preprocedural CT, and weren’t being anticoagulated.
“Importantly, in the overall TAVR cohort, 8 of the 10 patients with LAAT on CT did not have a clinically evident periprocedural stroke,” Dr. Williams noted.
Session chair Dr. Rajendra Makkar, director of interventional cardiology at the Cedars-Sinai Heart Institute in Los Angeles, commented, “Your study has very, very important implications for how we actually change the management of some of our patients. You’ve shown LAAT is much more important in TAVR patients than I’d thought. A stroke risk of 20% with LAAT versus 3.8% in patients without LAAT is an impressive difference.”
His take away lesson from the study, Dr. Makkar added, is that if a patient has a preprocedural CT scan that’s negative for LAAT, there’s no need to do a TEE. If CT is positive or nondefinitive, it makes sense to review the patient’s anticoagulation regimen, then bring the patient back a few weeks later for a TEE to see if the LAAT has resolved.
Dr. Williams replied that’s exactly the practice now being followed at his hospital. If CT shows LAAT in a patient with AF who’s already on warfarin, physicians will consider aiming for a higher target INR [international normalized ratio], or they’ll switch to one of the novel oral anticoagulants if there’s a warfarin compliance issue. Then they’ll bring the patient back for a TEE.
“If the TEE is positive for LAAT we will still offer them TAVR, with the use of an embolic protection device if the anatomy is suitable, but we will tell them that potentially they may be at higher risk of stroke,” Dr. Williams said.
He reported having no financial conflicts of interest regarding this study.
PARIS – Advances in CT scanner technology make cardiac CT a viable alternative to transesophageal echocardiography for preprocedural detection of left atrial appendage thrombus in candidates for transcatheter aortic valve replacement, Dr. Paul D. Williams said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
This strategy helps simplify transcatheter aortic valve replacement (TAVR). That has become a major goal for the field now that TAVR’s safety and effectiveness have been established, said Dr. Williams of James Cook University Hospital in Middlesbrough, England.
“With the use of CT as the preferred method for annular sizing prior to the procedure and the increasing use of conscious sedation, transesophageal echo can be avoided altogether in many patients. And identification of left atrial appendage thrombus [LAAT] on CT may lead to changes in management, including optimization of oral anticoagulation, the use of an embolic protection device, and possibly obtaining consent from patients for a higher risk of procedural stroke,” he added.
Transesophageal echocardiography (TEE) has long been considered the gold standard method for detecting LAAT. But it has several disadvantages: It’s invasive, requires heavy sedation, and poses a small risk of serious complications.
Dr. Williams presented a single-center prospective study involving 198 consecutive patients who underwent dual source CT scanning with retrospective gated acquisition and flash angiographic acquisition during their pre-TAVR workup. The study showed that atrial fibrillation (AF) is very common in TAVR candidates, that LAAT is far more common in the TAVR population with AF than in the general AF population, and that while TAVR can still be performed in patients with LAAT, the periprocedural stroke risk appears to be higher.
Of the 198 TAVR candidates, 32% had AF. Two independent cardiologists with CT expertise rated 11.1% of TAVR candidates as having definite LAAT on the basis of a filling defect in both phases of imaging. Another 83.8% were deemed to definitely not have LAAT, while in 5.1% of cases the CT image quality wasn’t sufficient to render a judgment.
“The literature would suggest only about 5% of patients in the general AF population have LAAT. The rate is much higher in a TAVR population,” the cardiologist observed.
As expected, AF was a strong predictor of LAAT being found on CT, with a 32% prevalence in the AF subgroup, compared with just 1.6% in patients without AF.
Ninety-eight patients with a diagnostic CT also had a TEE. Six of the eight with LAAT on CT also showed LAAT on TEE. Two patients had LAAT on CT but not TEE. Thus, CT had 100% sensitivity, 97.8% specificity, a 75% positive predictive value, and a 100% negative predictive value, Dr. Williams continued.
Of the 198 patients evaluated by CT, 124 actually underwent TAVR. AF was present in 34% of these patients, whose mean CHA2DS2-VASc score was 3.7. CT showed that 8.1% of the patients who had TAVR had definite LAAT, and 84.7% definitely did not.
Six of the 124 patients (4.8%) had a stroke during their hospital stay for TAVR. Two of the six had LAAT on their preprocedural CT; both were being anticoagulated with warfarin at the time. The other four patients with periprocedural stroke didn’t have AF, were negative for LAAT on preprocedural CT, and weren’t being anticoagulated.
“Importantly, in the overall TAVR cohort, 8 of the 10 patients with LAAT on CT did not have a clinically evident periprocedural stroke,” Dr. Williams noted.
Session chair Dr. Rajendra Makkar, director of interventional cardiology at the Cedars-Sinai Heart Institute in Los Angeles, commented, “Your study has very, very important implications for how we actually change the management of some of our patients. You’ve shown LAAT is much more important in TAVR patients than I’d thought. A stroke risk of 20% with LAAT versus 3.8% in patients without LAAT is an impressive difference.”
His take away lesson from the study, Dr. Makkar added, is that if a patient has a preprocedural CT scan that’s negative for LAAT, there’s no need to do a TEE. If CT is positive or nondefinitive, it makes sense to review the patient’s anticoagulation regimen, then bring the patient back a few weeks later for a TEE to see if the LAAT has resolved.
Dr. Williams replied that’s exactly the practice now being followed at his hospital. If CT shows LAAT in a patient with AF who’s already on warfarin, physicians will consider aiming for a higher target INR [international normalized ratio], or they’ll switch to one of the novel oral anticoagulants if there’s a warfarin compliance issue. Then they’ll bring the patient back for a TEE.
“If the TEE is positive for LAAT we will still offer them TAVR, with the use of an embolic protection device if the anatomy is suitable, but we will tell them that potentially they may be at higher risk of stroke,” Dr. Williams said.
He reported having no financial conflicts of interest regarding this study.
AT EUROPCR 2016
Key clinical point: It’s essential to look for left atrial appendage thrombus in all TAVR candidates, and second-generation CT scanning offers advantages for this purpose.
Major finding: Left atrial appendage thrombus was identified by CT in 11.1% of TAVR candidates.
Data source: A single-center study of 198 consecutive TAVR candidates who underwent CT scanning for detection of left atrial appendage thrombus as well as for annular sizing.
Disclosures: The presenter reported having no financial conflicts of interest regarding his study.
Prasugrel beats clopidogrel for complex PCI in ACS
PARIS – Patients undergoing complex percutaneous intervention for acute coronary syndrome fared significantly better with prasugrel than clopidogrel as antiplatelet therapy in the large, real-world PROMETHEUS registry, Dr. Jaya Chandrasekhar reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
Cumulative 1-year all-cause mortality was 8% with clopidogrel (Plavix), compared with 2% with prasugrel (Effient), for an adjusted 42% relative risk reduction favoring the more potent oral thienopyridine.
Moreover, the 1-year composite MACE (major adverse cardiac events) outcome comprising death, MI, stroke, or unplanned revascularization occurred in 24.3% of the clopidogrel group, compared with 13.3% of the prasugrel group. That translates to an adjusted 22% relative risk reduction, noted Dr. Chandrasekhar of Mount Sinai Medical Center in New York.
Bleeding rates were similar in the prasugrel and clopidogrel groups, she added.
She stressed that these findings must be viewed as hypothesis-generating rather than definitive, since PROMETHEUS was not a randomized clinical trial. Rather, it was a retrospective observational study of 19,914 patients who underwent PCI for ACS at eight major U.S. medical centers, 20% of whom got prasugrel, 80% clopidogrel. Half of the patients had a complex PCI, defined by Dr. Chandrasekhar and coinvestigators as one targeting the left main coronary artery, any bifurcation lesion, any moderate or severely calcified lesion, or an intervention resulting in a total stent length of 30 mm or longer.
The complex PCI patients were significantly older, by just under 2 years. They had higher rates of diabetes, unstable angina, and multivessel disease, and were more likely to receive at least one second-generation drug-eluting stent.
In a multivariate analysis adjusted for these potential confounders as well as race, body mass index, kidney function, hypertension, hemoglobin, previous PCI, and concomitant use of bivalirudin, the benefits of prasugrel over clopidogrel at 1 year remained significant in patients who underwent complex PCI. In contrast, among the 10,179 ACS patients who underwent noncomplex PCI, the trends favoring lower mortality and MACE in the prasugrel group no longer attained statistical significance upon multivariate adjustment, she said.
Discussant Dr. Pascal Meier said that registry data on prasugrel are inevitably biased because physicians don’t give the drug to patients older than 75 or patients who have had a prior stroke, are low weight, or low risk.
“Do you think there’s any way we can adjust for this bias?” asked Dr. Meier of University Hospital, Geneva.
Dr. Chandrasekhar conceded the possibility of unrecognized confounders.
“I think no matter what statistical methods you use, there will be that potential for bias. This is a real-world study. We understand that physicians and operators select their patients very carefully and the healthier ones get prasugrel rather than clopidogrel.”
She reported having no financial conflicts regarding this study. PROMETHEUS was sponsored and funded by Daiichi Sankyo and Eli Lilly.
PARIS – Patients undergoing complex percutaneous intervention for acute coronary syndrome fared significantly better with prasugrel than clopidogrel as antiplatelet therapy in the large, real-world PROMETHEUS registry, Dr. Jaya Chandrasekhar reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
Cumulative 1-year all-cause mortality was 8% with clopidogrel (Plavix), compared with 2% with prasugrel (Effient), for an adjusted 42% relative risk reduction favoring the more potent oral thienopyridine.
Moreover, the 1-year composite MACE (major adverse cardiac events) outcome comprising death, MI, stroke, or unplanned revascularization occurred in 24.3% of the clopidogrel group, compared with 13.3% of the prasugrel group. That translates to an adjusted 22% relative risk reduction, noted Dr. Chandrasekhar of Mount Sinai Medical Center in New York.
Bleeding rates were similar in the prasugrel and clopidogrel groups, she added.
She stressed that these findings must be viewed as hypothesis-generating rather than definitive, since PROMETHEUS was not a randomized clinical trial. Rather, it was a retrospective observational study of 19,914 patients who underwent PCI for ACS at eight major U.S. medical centers, 20% of whom got prasugrel, 80% clopidogrel. Half of the patients had a complex PCI, defined by Dr. Chandrasekhar and coinvestigators as one targeting the left main coronary artery, any bifurcation lesion, any moderate or severely calcified lesion, or an intervention resulting in a total stent length of 30 mm or longer.
The complex PCI patients were significantly older, by just under 2 years. They had higher rates of diabetes, unstable angina, and multivessel disease, and were more likely to receive at least one second-generation drug-eluting stent.
In a multivariate analysis adjusted for these potential confounders as well as race, body mass index, kidney function, hypertension, hemoglobin, previous PCI, and concomitant use of bivalirudin, the benefits of prasugrel over clopidogrel at 1 year remained significant in patients who underwent complex PCI. In contrast, among the 10,179 ACS patients who underwent noncomplex PCI, the trends favoring lower mortality and MACE in the prasugrel group no longer attained statistical significance upon multivariate adjustment, she said.
Discussant Dr. Pascal Meier said that registry data on prasugrel are inevitably biased because physicians don’t give the drug to patients older than 75 or patients who have had a prior stroke, are low weight, or low risk.
“Do you think there’s any way we can adjust for this bias?” asked Dr. Meier of University Hospital, Geneva.
Dr. Chandrasekhar conceded the possibility of unrecognized confounders.
“I think no matter what statistical methods you use, there will be that potential for bias. This is a real-world study. We understand that physicians and operators select their patients very carefully and the healthier ones get prasugrel rather than clopidogrel.”
She reported having no financial conflicts regarding this study. PROMETHEUS was sponsored and funded by Daiichi Sankyo and Eli Lilly.
PARIS – Patients undergoing complex percutaneous intervention for acute coronary syndrome fared significantly better with prasugrel than clopidogrel as antiplatelet therapy in the large, real-world PROMETHEUS registry, Dr. Jaya Chandrasekhar reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
Cumulative 1-year all-cause mortality was 8% with clopidogrel (Plavix), compared with 2% with prasugrel (Effient), for an adjusted 42% relative risk reduction favoring the more potent oral thienopyridine.
Moreover, the 1-year composite MACE (major adverse cardiac events) outcome comprising death, MI, stroke, or unplanned revascularization occurred in 24.3% of the clopidogrel group, compared with 13.3% of the prasugrel group. That translates to an adjusted 22% relative risk reduction, noted Dr. Chandrasekhar of Mount Sinai Medical Center in New York.
Bleeding rates were similar in the prasugrel and clopidogrel groups, she added.
She stressed that these findings must be viewed as hypothesis-generating rather than definitive, since PROMETHEUS was not a randomized clinical trial. Rather, it was a retrospective observational study of 19,914 patients who underwent PCI for ACS at eight major U.S. medical centers, 20% of whom got prasugrel, 80% clopidogrel. Half of the patients had a complex PCI, defined by Dr. Chandrasekhar and coinvestigators as one targeting the left main coronary artery, any bifurcation lesion, any moderate or severely calcified lesion, or an intervention resulting in a total stent length of 30 mm or longer.
The complex PCI patients were significantly older, by just under 2 years. They had higher rates of diabetes, unstable angina, and multivessel disease, and were more likely to receive at least one second-generation drug-eluting stent.
In a multivariate analysis adjusted for these potential confounders as well as race, body mass index, kidney function, hypertension, hemoglobin, previous PCI, and concomitant use of bivalirudin, the benefits of prasugrel over clopidogrel at 1 year remained significant in patients who underwent complex PCI. In contrast, among the 10,179 ACS patients who underwent noncomplex PCI, the trends favoring lower mortality and MACE in the prasugrel group no longer attained statistical significance upon multivariate adjustment, she said.
Discussant Dr. Pascal Meier said that registry data on prasugrel are inevitably biased because physicians don’t give the drug to patients older than 75 or patients who have had a prior stroke, are low weight, or low risk.
“Do you think there’s any way we can adjust for this bias?” asked Dr. Meier of University Hospital, Geneva.
Dr. Chandrasekhar conceded the possibility of unrecognized confounders.
“I think no matter what statistical methods you use, there will be that potential for bias. This is a real-world study. We understand that physicians and operators select their patients very carefully and the healthier ones get prasugrel rather than clopidogrel.”
She reported having no financial conflicts regarding this study. PROMETHEUS was sponsored and funded by Daiichi Sankyo and Eli Lilly.
AT EUROPCR 2016
Key clinical point: One-year outcomes were significantly better following complex PCI for acute coronary syndrome in prasugrel rather than in clopidogrel recipients.
Major finding: The composite rate of mortality, MI, stroke, or unplanned revascularization 1 year after patients underwent complex PCI for ACS was 13.3% in those who received prasugrel, compared with 24.3% in patients given clopidogrel.
Data source: PROMETHEUS, a retrospective observational study of 19,914 patients who underwent PCI for ACS at eight major U.S. medical centers.
Disclosures: Daiichi Sankyo and Eli Lilly sponsored and funded the study. The presenter reported having no conflicts of interest.
Watchman registry provides reassuring answers on device safety
PARIS – Results of the real-world EWOLUTION registry of recipients of the Watchman device for stroke prevention provide reassuring answers to several key questions which have slowed physician uptake of the left atrial appendage closure device, Dr. Martin W. Bergmann said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“EWOLUTION, with more than 1,000 patients, is I think the study that we’ve needed to make this intervention happen in routine practice as a procedure for stroke prevention in atrial fibrillation,” declared Dr. Bergmann of Cardiologicum Hamburg, a large German group practice.
EWOLUTION is a prospective, single-arm, multicenter registry including 1,025 recipients of the first-generation version of the Watchman, a transcatheter device for left atrial appendage closure as a means of stroke prevention in patients with atrial fibrillation (AF). These were high-risk patients: 50% of them had a CHA2DS2-VASc score of 5 or higher, and 72% of participants were deemed unsuitable for warfarin. EWOLUTION was conducted at 47 sites in Europe, the Middle East, and Russia. Dr. Bergmann presented the 3-month outcomes, a key period for device-related complications because protective epithelialization of the device isn’t yet complete. Follow-up will continue at the 1- and 2-year marks.
Among the key findings in the domain of procedural success: The rate of successful device implantation was 98.5%. A complete seal or an echocardiographic color jet of 5 mm or less at the time of implantation was achieved in 99.7% of cases, and this remained the case in 98.9% at 3 months.
With regard to safety, the stroke rate was 0.4%, device embolization occurred in 0.4%, and the pericardial effusion/tamponade rate was 0.7%, all of which are lower rates than in earlier clinical trials.
Just over 4% of patients experienced device-related adverse events with full recovery at the 3-month follow-up. These were mostly bleeding events at the groin access site. More importantly, only 0.5% of patients had device-related serious adverse events that weren’t resolved at 3 months.
“This 0.5% is a major step forward,” Dr. Bergmann said. “This includes all pericardial effusions, all device embolizations, all periprocedural strokes – everything involving the procedure that puts a patient at risk. In fact, that 0.5% risk for left atrial appendage closure with the Watchman is pretty much the same risk as if you refer your patient with AF to an electrophysiologist for pulmonary vein isolation.”
One key question answered by EWOLUTION is, do you need to be an expert in the procedure in order to get excellent results? The answer, Dr. Bergmann said, is emphatically “no.” Interventionalists at the 47 participating sites varied widely in their experience with left atrial appendage occlusion, so investigators divided the sites into quartiles based upon experience and patient volumes contributed to the registry. While cardiologists in the most experienced centers had a significantly higher rate of successful device release on the first try, the most- and least-experienced centers did equally well on the endpoint that really counts: a complete or near-complete seal of the left atrial appendage at follow-up. Complication rates didn’t differ by site experience, either.
Another important practical question that’s been holding up wider adoption of the Watchman concerns how best to handle postimplantation antithrombotic therapy. Here the EWOLUTION registry provides a partial answer: 607 patients were on dual antiplatelet therapy, 113 were on a novel anticoagulant (NOAC), 159 were on warfarin, 67 were on nothing at all, and the rest were on a single antiplatelet agent. And there was no significant difference between any of these groups in the 3-month rates of thrombus on the device, bleeding events, stroke, or other adverse events.
“The main message is there is no difference in serious adverse events between any of the drug regimens. So if you’re in a situation where you can’t give any medication to reduce stroke risk because the bleeding risk is so high, you can go for left atrial appendage closure technology and give them nothing post implant,” according to Dr. Bergmann.
He added that he’d personally try to avoid that strategy: “You want to have some coverage.”
Also noteworthy is that 113 Watchman recipients did well with 3 months of NOAC monotherapy. The appeal of that approach is the short half-life of those agents in the event of a bleeding problem.
Discussant Dr. Farrel Hellig commented that EWOLUTION demonstrates that the Watchman procedure is predictable and safe, with an impressively low complication rate even in inexperienced centers. For that, he added, kudos goes to Boston Scientific, which markets the Watchman, for rolling out an effective physician training program.
“The most important topic to discuss is bleeding, because a bleeding rate of 4.1% at 3 months is certainly not insignificant,” he continued. “It appears, firstly, from EWOLUTION that it’s safe to omit warfarin. I think the most important thing we’d like to know now is could a postprocedure NOAC be the best option, and can aspirin be eliminated in the long term?”
“Is it too early to recommend a NOAC-only for a period of time post procedure? Perhaps. But I think this would be an important next clinical trial: a NOAC-only for a period post procedure with no aspirin to follow. This is the next piece of information we need to complete the puzzle and for left atrial appendage closure to reach its full potential,” according to Dr. Hellig of the University of Cape Town (South Africa).
The EWOLUTION registry is sponsored by Boston Scientific. Dr. Bergmann reported serving as a consultant to Boston Scientific and Biosense Webster and receiving honoraria from more than a half-dozen pharmaceutical and device companies.
PARIS – Results of the real-world EWOLUTION registry of recipients of the Watchman device for stroke prevention provide reassuring answers to several key questions which have slowed physician uptake of the left atrial appendage closure device, Dr. Martin W. Bergmann said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“EWOLUTION, with more than 1,000 patients, is I think the study that we’ve needed to make this intervention happen in routine practice as a procedure for stroke prevention in atrial fibrillation,” declared Dr. Bergmann of Cardiologicum Hamburg, a large German group practice.
EWOLUTION is a prospective, single-arm, multicenter registry including 1,025 recipients of the first-generation version of the Watchman, a transcatheter device for left atrial appendage closure as a means of stroke prevention in patients with atrial fibrillation (AF). These were high-risk patients: 50% of them had a CHA2DS2-VASc score of 5 or higher, and 72% of participants were deemed unsuitable for warfarin. EWOLUTION was conducted at 47 sites in Europe, the Middle East, and Russia. Dr. Bergmann presented the 3-month outcomes, a key period for device-related complications because protective epithelialization of the device isn’t yet complete. Follow-up will continue at the 1- and 2-year marks.
Among the key findings in the domain of procedural success: The rate of successful device implantation was 98.5%. A complete seal or an echocardiographic color jet of 5 mm or less at the time of implantation was achieved in 99.7% of cases, and this remained the case in 98.9% at 3 months.
With regard to safety, the stroke rate was 0.4%, device embolization occurred in 0.4%, and the pericardial effusion/tamponade rate was 0.7%, all of which are lower rates than in earlier clinical trials.
Just over 4% of patients experienced device-related adverse events with full recovery at the 3-month follow-up. These were mostly bleeding events at the groin access site. More importantly, only 0.5% of patients had device-related serious adverse events that weren’t resolved at 3 months.
“This 0.5% is a major step forward,” Dr. Bergmann said. “This includes all pericardial effusions, all device embolizations, all periprocedural strokes – everything involving the procedure that puts a patient at risk. In fact, that 0.5% risk for left atrial appendage closure with the Watchman is pretty much the same risk as if you refer your patient with AF to an electrophysiologist for pulmonary vein isolation.”
One key question answered by EWOLUTION is, do you need to be an expert in the procedure in order to get excellent results? The answer, Dr. Bergmann said, is emphatically “no.” Interventionalists at the 47 participating sites varied widely in their experience with left atrial appendage occlusion, so investigators divided the sites into quartiles based upon experience and patient volumes contributed to the registry. While cardiologists in the most experienced centers had a significantly higher rate of successful device release on the first try, the most- and least-experienced centers did equally well on the endpoint that really counts: a complete or near-complete seal of the left atrial appendage at follow-up. Complication rates didn’t differ by site experience, either.
Another important practical question that’s been holding up wider adoption of the Watchman concerns how best to handle postimplantation antithrombotic therapy. Here the EWOLUTION registry provides a partial answer: 607 patients were on dual antiplatelet therapy, 113 were on a novel anticoagulant (NOAC), 159 were on warfarin, 67 were on nothing at all, and the rest were on a single antiplatelet agent. And there was no significant difference between any of these groups in the 3-month rates of thrombus on the device, bleeding events, stroke, or other adverse events.
“The main message is there is no difference in serious adverse events between any of the drug regimens. So if you’re in a situation where you can’t give any medication to reduce stroke risk because the bleeding risk is so high, you can go for left atrial appendage closure technology and give them nothing post implant,” according to Dr. Bergmann.
He added that he’d personally try to avoid that strategy: “You want to have some coverage.”
Also noteworthy is that 113 Watchman recipients did well with 3 months of NOAC monotherapy. The appeal of that approach is the short half-life of those agents in the event of a bleeding problem.
Discussant Dr. Farrel Hellig commented that EWOLUTION demonstrates that the Watchman procedure is predictable and safe, with an impressively low complication rate even in inexperienced centers. For that, he added, kudos goes to Boston Scientific, which markets the Watchman, for rolling out an effective physician training program.
“The most important topic to discuss is bleeding, because a bleeding rate of 4.1% at 3 months is certainly not insignificant,” he continued. “It appears, firstly, from EWOLUTION that it’s safe to omit warfarin. I think the most important thing we’d like to know now is could a postprocedure NOAC be the best option, and can aspirin be eliminated in the long term?”
“Is it too early to recommend a NOAC-only for a period of time post procedure? Perhaps. But I think this would be an important next clinical trial: a NOAC-only for a period post procedure with no aspirin to follow. This is the next piece of information we need to complete the puzzle and for left atrial appendage closure to reach its full potential,” according to Dr. Hellig of the University of Cape Town (South Africa).
The EWOLUTION registry is sponsored by Boston Scientific. Dr. Bergmann reported serving as a consultant to Boston Scientific and Biosense Webster and receiving honoraria from more than a half-dozen pharmaceutical and device companies.
PARIS – Results of the real-world EWOLUTION registry of recipients of the Watchman device for stroke prevention provide reassuring answers to several key questions which have slowed physician uptake of the left atrial appendage closure device, Dr. Martin W. Bergmann said at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“EWOLUTION, with more than 1,000 patients, is I think the study that we’ve needed to make this intervention happen in routine practice as a procedure for stroke prevention in atrial fibrillation,” declared Dr. Bergmann of Cardiologicum Hamburg, a large German group practice.
EWOLUTION is a prospective, single-arm, multicenter registry including 1,025 recipients of the first-generation version of the Watchman, a transcatheter device for left atrial appendage closure as a means of stroke prevention in patients with atrial fibrillation (AF). These were high-risk patients: 50% of them had a CHA2DS2-VASc score of 5 or higher, and 72% of participants were deemed unsuitable for warfarin. EWOLUTION was conducted at 47 sites in Europe, the Middle East, and Russia. Dr. Bergmann presented the 3-month outcomes, a key period for device-related complications because protective epithelialization of the device isn’t yet complete. Follow-up will continue at the 1- and 2-year marks.
Among the key findings in the domain of procedural success: The rate of successful device implantation was 98.5%. A complete seal or an echocardiographic color jet of 5 mm or less at the time of implantation was achieved in 99.7% of cases, and this remained the case in 98.9% at 3 months.
With regard to safety, the stroke rate was 0.4%, device embolization occurred in 0.4%, and the pericardial effusion/tamponade rate was 0.7%, all of which are lower rates than in earlier clinical trials.
Just over 4% of patients experienced device-related adverse events with full recovery at the 3-month follow-up. These were mostly bleeding events at the groin access site. More importantly, only 0.5% of patients had device-related serious adverse events that weren’t resolved at 3 months.
“This 0.5% is a major step forward,” Dr. Bergmann said. “This includes all pericardial effusions, all device embolizations, all periprocedural strokes – everything involving the procedure that puts a patient at risk. In fact, that 0.5% risk for left atrial appendage closure with the Watchman is pretty much the same risk as if you refer your patient with AF to an electrophysiologist for pulmonary vein isolation.”
One key question answered by EWOLUTION is, do you need to be an expert in the procedure in order to get excellent results? The answer, Dr. Bergmann said, is emphatically “no.” Interventionalists at the 47 participating sites varied widely in their experience with left atrial appendage occlusion, so investigators divided the sites into quartiles based upon experience and patient volumes contributed to the registry. While cardiologists in the most experienced centers had a significantly higher rate of successful device release on the first try, the most- and least-experienced centers did equally well on the endpoint that really counts: a complete or near-complete seal of the left atrial appendage at follow-up. Complication rates didn’t differ by site experience, either.
Another important practical question that’s been holding up wider adoption of the Watchman concerns how best to handle postimplantation antithrombotic therapy. Here the EWOLUTION registry provides a partial answer: 607 patients were on dual antiplatelet therapy, 113 were on a novel anticoagulant (NOAC), 159 were on warfarin, 67 were on nothing at all, and the rest were on a single antiplatelet agent. And there was no significant difference between any of these groups in the 3-month rates of thrombus on the device, bleeding events, stroke, or other adverse events.
“The main message is there is no difference in serious adverse events between any of the drug regimens. So if you’re in a situation where you can’t give any medication to reduce stroke risk because the bleeding risk is so high, you can go for left atrial appendage closure technology and give them nothing post implant,” according to Dr. Bergmann.
He added that he’d personally try to avoid that strategy: “You want to have some coverage.”
Also noteworthy is that 113 Watchman recipients did well with 3 months of NOAC monotherapy. The appeal of that approach is the short half-life of those agents in the event of a bleeding problem.
Discussant Dr. Farrel Hellig commented that EWOLUTION demonstrates that the Watchman procedure is predictable and safe, with an impressively low complication rate even in inexperienced centers. For that, he added, kudos goes to Boston Scientific, which markets the Watchman, for rolling out an effective physician training program.
“The most important topic to discuss is bleeding, because a bleeding rate of 4.1% at 3 months is certainly not insignificant,” he continued. “It appears, firstly, from EWOLUTION that it’s safe to omit warfarin. I think the most important thing we’d like to know now is could a postprocedure NOAC be the best option, and can aspirin be eliminated in the long term?”
“Is it too early to recommend a NOAC-only for a period of time post procedure? Perhaps. But I think this would be an important next clinical trial: a NOAC-only for a period post procedure with no aspirin to follow. This is the next piece of information we need to complete the puzzle and for left atrial appendage closure to reach its full potential,” according to Dr. Hellig of the University of Cape Town (South Africa).
The EWOLUTION registry is sponsored by Boston Scientific. Dr. Bergmann reported serving as a consultant to Boston Scientific and Biosense Webster and receiving honoraria from more than a half-dozen pharmaceutical and device companies.
AT EUROPCR 2016
Key clinical point: You don’t have to be an expert at implanting the Watchman left atrial appendage closure device to achieve the same sort of sky-high procedural success and low complication rates the experts do.
Major finding: The Watchman device successfully sealed off the left atrial appendage in 98.9% of cases at 3 months follow-up, with rates closely similar at the least- and most-experienced centers.
Data source: EWOLUTION is a prospective, multicenter, real-world registry of 1,025 recipients of the Watchman left atrial appendage closure device at 47 sites in Europe, the Middle East, and Russia.
Disclosures: The EWOLUTION registry is sponsored by Boston Scientific. The presenter reported serving as a consultant to Boston Scientific and Biosense Webster and receiving honoraria from more than a half-dozen pharmaceutical and device companies.
Upper extremity dysfunction from transradial PCI underappreciated
PARIS – Fully 75% of patients experience clinically significant upper extremity dysfunction in one or more key domains upon formal testing 2 weeks after transradial artery access percutaneous coronary intervention, according to an interim analysis of what’s believed to be the first-ever prospective multicenter observational study to examine this procedural complication.
Moreover, 7.3% of all patients who underwent transradial PCI and 1 in 10 of those who developed upper extremity dysfunction were found to have radial artery occlusion upon echo Doppler examination, performed routinely as part of the extensive testing in this study, Dr. Eva M. Zwaan said in presenting the preliminary findings at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“Based upon what we’ve found, I think that for people who use their hands for their profession, like musicians, I would advise that they avoid transradial PCI in favor of femoral access,” added Dr. Zwaan of Albert Schweitzer Hospital in Dordrecht, The Netherlands.
Jaws were seen to drop among stunned audience members upon seeing Dr. Zwaan’s data. Transradial PCI is far more popular among European and Asian cardiologists than in the United States, and the possibility that the procedure might cause lingering upper extremity dysfunction or disability seems not to have occurred to most practitioners.
“This is a very important study because I think we’ve all taken it for granted that upper extremity function is good after transradial PCI,” said session chair Dr. Ibrahim Al Rashdan of Kuwait Heart Center. He added that in his view this new information is sufficiently compelling that it must be shared with patients in the preprocedural conversation about risks and benefits.
“It feels to me as if you’ve dropped a small hand grenade into the radial access community,” observed discussant Dr. David Kettles of St. Dominic’s Private Hospital in East London, South Africa. “I think your 6-month follow-up data will be absolutely key.”
Dr. Zwaan concurred. Even though the 2-week follow-up is the primary study endpoint, the same rigorous multidimensional testing of hand, wrist, arm, and shoulder function will take place at 1 and 6 months. By 6 months, she noted, the acute phase of injury is over, all hematomas should have been resorbed, and investigators will have a much clearer picture of the true long-term consequences.
“These are very interesting findings, but we still have a lot to do,” she said.
She reported on the first 191 patients to complete the upper extremity assessment 2 weeks after transradial PCI. Enrollment continues in the ongoing multicenter prospective study, planned for 500 patients. Investigators will look at whether the new slender PCI systems result in less upper extremity dysfunction. They also plan to conduct a substudy of the impact of early referral of affected patients to a hand rehabilitation specialist for treatment.
With input provided by distinguished Dutch hand surgeons, the investigators are assessing multiple domains of hand function pre- and post treatment. These include range of motion, coordination, sensation, absence of pain, anatomic integrity, and strength.
In addition to echo Doppler, the assessment includes volumetric measurements of hand and forearm swelling, fingertip sensation as measured by the Weinstein Enhanced Sensory Test, palmar grip and key strength tested by dynamometer, isometric strength at the wrist and elbow, the Disabilities of the Arm, Shoulder, and Hand Questionnaire, the Boston Carpal Tunnel Questionnaire, and a visual analog pain assessment. The tests are repeated on the uninvolved upper extremity as a control arm. Patients were classified as having clinically meaningful upper extremity dysfunction if they scored positive on any 2 or more of 14 test variables.
There were three main drivers of upper extremity dysfunction: diminished wrist strength, increased hand swelling, and decreased sensation, Dr. Zwaan continued.
Interestingly, a popular entertainment at EuroPCR 2016 was a self-congratulatory sort of mocking of what is widely viewed by European and Asian cardiologists as the laggardly low transradial PCR rates in the United States. At one session, a speaker asked for an audience show of hands as to what percentage of their PCIs are performed transradially. At 70% or more, virtually every arm in the room shot up. At 90%, plenty of hands remained in the air. “Well, I guess there are no American cardiologists in the audience,” the speaker quipped.
Dr. Zwaan had no financial conflicts of interest regarding this study, conducted free of commercial support.
PARIS – Fully 75% of patients experience clinically significant upper extremity dysfunction in one or more key domains upon formal testing 2 weeks after transradial artery access percutaneous coronary intervention, according to an interim analysis of what’s believed to be the first-ever prospective multicenter observational study to examine this procedural complication.
Moreover, 7.3% of all patients who underwent transradial PCI and 1 in 10 of those who developed upper extremity dysfunction were found to have radial artery occlusion upon echo Doppler examination, performed routinely as part of the extensive testing in this study, Dr. Eva M. Zwaan said in presenting the preliminary findings at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“Based upon what we’ve found, I think that for people who use their hands for their profession, like musicians, I would advise that they avoid transradial PCI in favor of femoral access,” added Dr. Zwaan of Albert Schweitzer Hospital in Dordrecht, The Netherlands.
Jaws were seen to drop among stunned audience members upon seeing Dr. Zwaan’s data. Transradial PCI is far more popular among European and Asian cardiologists than in the United States, and the possibility that the procedure might cause lingering upper extremity dysfunction or disability seems not to have occurred to most practitioners.
“This is a very important study because I think we’ve all taken it for granted that upper extremity function is good after transradial PCI,” said session chair Dr. Ibrahim Al Rashdan of Kuwait Heart Center. He added that in his view this new information is sufficiently compelling that it must be shared with patients in the preprocedural conversation about risks and benefits.
“It feels to me as if you’ve dropped a small hand grenade into the radial access community,” observed discussant Dr. David Kettles of St. Dominic’s Private Hospital in East London, South Africa. “I think your 6-month follow-up data will be absolutely key.”
Dr. Zwaan concurred. Even though the 2-week follow-up is the primary study endpoint, the same rigorous multidimensional testing of hand, wrist, arm, and shoulder function will take place at 1 and 6 months. By 6 months, she noted, the acute phase of injury is over, all hematomas should have been resorbed, and investigators will have a much clearer picture of the true long-term consequences.
“These are very interesting findings, but we still have a lot to do,” she said.
She reported on the first 191 patients to complete the upper extremity assessment 2 weeks after transradial PCI. Enrollment continues in the ongoing multicenter prospective study, planned for 500 patients. Investigators will look at whether the new slender PCI systems result in less upper extremity dysfunction. They also plan to conduct a substudy of the impact of early referral of affected patients to a hand rehabilitation specialist for treatment.
With input provided by distinguished Dutch hand surgeons, the investigators are assessing multiple domains of hand function pre- and post treatment. These include range of motion, coordination, sensation, absence of pain, anatomic integrity, and strength.
In addition to echo Doppler, the assessment includes volumetric measurements of hand and forearm swelling, fingertip sensation as measured by the Weinstein Enhanced Sensory Test, palmar grip and key strength tested by dynamometer, isometric strength at the wrist and elbow, the Disabilities of the Arm, Shoulder, and Hand Questionnaire, the Boston Carpal Tunnel Questionnaire, and a visual analog pain assessment. The tests are repeated on the uninvolved upper extremity as a control arm. Patients were classified as having clinically meaningful upper extremity dysfunction if they scored positive on any 2 or more of 14 test variables.
There were three main drivers of upper extremity dysfunction: diminished wrist strength, increased hand swelling, and decreased sensation, Dr. Zwaan continued.
Interestingly, a popular entertainment at EuroPCR 2016 was a self-congratulatory sort of mocking of what is widely viewed by European and Asian cardiologists as the laggardly low transradial PCR rates in the United States. At one session, a speaker asked for an audience show of hands as to what percentage of their PCIs are performed transradially. At 70% or more, virtually every arm in the room shot up. At 90%, plenty of hands remained in the air. “Well, I guess there are no American cardiologists in the audience,” the speaker quipped.
Dr. Zwaan had no financial conflicts of interest regarding this study, conducted free of commercial support.
PARIS – Fully 75% of patients experience clinically significant upper extremity dysfunction in one or more key domains upon formal testing 2 weeks after transradial artery access percutaneous coronary intervention, according to an interim analysis of what’s believed to be the first-ever prospective multicenter observational study to examine this procedural complication.
Moreover, 7.3% of all patients who underwent transradial PCI and 1 in 10 of those who developed upper extremity dysfunction were found to have radial artery occlusion upon echo Doppler examination, performed routinely as part of the extensive testing in this study, Dr. Eva M. Zwaan said in presenting the preliminary findings at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“Based upon what we’ve found, I think that for people who use their hands for their profession, like musicians, I would advise that they avoid transradial PCI in favor of femoral access,” added Dr. Zwaan of Albert Schweitzer Hospital in Dordrecht, The Netherlands.
Jaws were seen to drop among stunned audience members upon seeing Dr. Zwaan’s data. Transradial PCI is far more popular among European and Asian cardiologists than in the United States, and the possibility that the procedure might cause lingering upper extremity dysfunction or disability seems not to have occurred to most practitioners.
“This is a very important study because I think we’ve all taken it for granted that upper extremity function is good after transradial PCI,” said session chair Dr. Ibrahim Al Rashdan of Kuwait Heart Center. He added that in his view this new information is sufficiently compelling that it must be shared with patients in the preprocedural conversation about risks and benefits.
“It feels to me as if you’ve dropped a small hand grenade into the radial access community,” observed discussant Dr. David Kettles of St. Dominic’s Private Hospital in East London, South Africa. “I think your 6-month follow-up data will be absolutely key.”
Dr. Zwaan concurred. Even though the 2-week follow-up is the primary study endpoint, the same rigorous multidimensional testing of hand, wrist, arm, and shoulder function will take place at 1 and 6 months. By 6 months, she noted, the acute phase of injury is over, all hematomas should have been resorbed, and investigators will have a much clearer picture of the true long-term consequences.
“These are very interesting findings, but we still have a lot to do,” she said.
She reported on the first 191 patients to complete the upper extremity assessment 2 weeks after transradial PCI. Enrollment continues in the ongoing multicenter prospective study, planned for 500 patients. Investigators will look at whether the new slender PCI systems result in less upper extremity dysfunction. They also plan to conduct a substudy of the impact of early referral of affected patients to a hand rehabilitation specialist for treatment.
With input provided by distinguished Dutch hand surgeons, the investigators are assessing multiple domains of hand function pre- and post treatment. These include range of motion, coordination, sensation, absence of pain, anatomic integrity, and strength.
In addition to echo Doppler, the assessment includes volumetric measurements of hand and forearm swelling, fingertip sensation as measured by the Weinstein Enhanced Sensory Test, palmar grip and key strength tested by dynamometer, isometric strength at the wrist and elbow, the Disabilities of the Arm, Shoulder, and Hand Questionnaire, the Boston Carpal Tunnel Questionnaire, and a visual analog pain assessment. The tests are repeated on the uninvolved upper extremity as a control arm. Patients were classified as having clinically meaningful upper extremity dysfunction if they scored positive on any 2 or more of 14 test variables.
There were three main drivers of upper extremity dysfunction: diminished wrist strength, increased hand swelling, and decreased sensation, Dr. Zwaan continued.
Interestingly, a popular entertainment at EuroPCR 2016 was a self-congratulatory sort of mocking of what is widely viewed by European and Asian cardiologists as the laggardly low transradial PCR rates in the United States. At one session, a speaker asked for an audience show of hands as to what percentage of their PCIs are performed transradially. At 70% or more, virtually every arm in the room shot up. At 90%, plenty of hands remained in the air. “Well, I guess there are no American cardiologists in the audience,” the speaker quipped.
Dr. Zwaan had no financial conflicts of interest regarding this study, conducted free of commercial support.
AT EUROPCR 2016
Key clinical point: Significant hand/wrist dysfunction is common 2 weeks after transradial PCI.
Major finding: Seventy-five percent of 191 patients who underwent PCI by transradial artery access had objective evidence of upper extremity dysfunction 2 weeks afterward.
Data source: An interim analysis of an ongoing multicenter prospective observational study that included 191 patients who underwent comprehensive testing of hand, wrist, arm, and shoulder function before and 2 weeks after transradial PCI.
Disclosures: The presenter reported having no financial conflicts of interest. The study was conducted free of commercial support.
Drug-coated stent sets new standard in ACS patients at high bleeding risk
PARIS – In patients at high bleeding risk undergoing percutaneous coronary intervention for acute coronary syndrome, a unique drug-coated, polymer-free stent backed by just a single month of dual-antiplatelet therapy (DAPT) trounced a bare metal stent in both efficacy and safety at 1 year in a large randomized trial, Dr. Christoph K. Naber reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The BioFreedom stent, coated with a proprietary sirolimus analogue called Biolimus-A9, rapidly transfers the drug to the vessel wall, leaving in place a metallic stent. This drug-coated stent (DCS) provides the antirestenotic benefits of a drug-eluting stent with the advantages of a shorter DAPT requirement and no potential polymer-related adverse events. The device’s performance in this prespecified subgroup analysis of the Leaders Free trial will be practice altering, predicted Dr. Naber of Elisabeth University Hospital in Essen, Germany.
“We believe that current guidelines and clinical practice need to change. Bare-metal stents can no longer be recommended for high–bleeding risk patients presenting with ACS. The Biolimus-A9–coated stent currently has the best supporting evidence for this indication,” he said.
“This was the last chance for bare metal stents to show a good indication. They were thought to be good only in high–bleeding risk patients. Now we see that a drug-coated stent provides better efficacy and is even safer,” the cardiologist continued.
Leaders Free was a randomized double-blind clinical trial in which 2,499 patients at high risk of bleeding who underwent PCI received either the DCS or the Gazelle bare-metal stent (BMS) and 1 month of dual-antiplatelet therapy. The main results, in which the DCS showed superior safety and efficacy at 12 months of follow-up, have been published (N Engl J Med. 2015 Nov 19;373[21]:2038-47).
Dr. Naber presented a prespecified subgroup analysis that included the 659 Leaders Free participants who presented with ACS.
The primary efficacy endpoint – the 12-month rate of clinically driven target lesion revascularization – was 3.9% in the DCS group, compared with 9% in patients randomized to the BMS, for an adjusted 59% relative risk reduction.
The composite safety endpoint was composed of the 1-year rate of cardiac death, acute MI, and definite or probable stent thrombosis. This occurred in 9.3% of the DCS- and 18.5% of the BMS-treated patients, for a relative risk reduction of 52%.
The BioFreedom stent has a selectively microstructured surface coated with Biolimus-A9, a drug that’s far more lipophilic than sirolimus, everolimus, or zotarolimus. As a result, 98% of the drug is transferred to the plaque-laden vessel within 30 days, which is why it’s safe to shorten DAPT to 1 month, Dr. Naber explained.
It’s estimated that up to 20% of patients undergoing PCI are at high bleeding risk for various reasons.
The DCS is marketed in Europe and in clinical trials in the United States aimed at getting Food and Drug Administration approval.
Discussant Dr. Thomas Cuisset of Timone Hospital in Marseille, France, agreed that “in 2016, bare-metal stents are no longer the gold standard in patients at high bleeding risk.”
He added that the Leaders Free ACS substudy leaves unanswered two major remaining questions: What’s the optimal duration of DAPT for DCS in non-ACS patients at high bleeding risk – is 1 month of DAPT as safe as 6 months? And how do contemporary drug-eluting, polymer-based stents compare to the BioFreedom stent for PCI in the setting of high bleeding risk?
In an interview, Dr. Naber said that before a head-to-head comparative clinical trial can even be considered, there will need to be evidence that drug-eluting stents are safe with shortened DAPT. That has yet to be shown.
The study was funded by Biosensors. Dr. Naber reported receiving consultant’s fees from that medical device company and several others. Dr. Cuisset serves as a consultant to or paid lecturer for more than a dozen medical companies.
Simultaneous with Dr. Naber’s presentation at EuroPCR in Paris, the Leaders Free ACS substudy results were published online (Eur Heart J. doi:10.1093/eurheartj/ehw203).
PARIS – In patients at high bleeding risk undergoing percutaneous coronary intervention for acute coronary syndrome, a unique drug-coated, polymer-free stent backed by just a single month of dual-antiplatelet therapy (DAPT) trounced a bare metal stent in both efficacy and safety at 1 year in a large randomized trial, Dr. Christoph K. Naber reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The BioFreedom stent, coated with a proprietary sirolimus analogue called Biolimus-A9, rapidly transfers the drug to the vessel wall, leaving in place a metallic stent. This drug-coated stent (DCS) provides the antirestenotic benefits of a drug-eluting stent with the advantages of a shorter DAPT requirement and no potential polymer-related adverse events. The device’s performance in this prespecified subgroup analysis of the Leaders Free trial will be practice altering, predicted Dr. Naber of Elisabeth University Hospital in Essen, Germany.
“We believe that current guidelines and clinical practice need to change. Bare-metal stents can no longer be recommended for high–bleeding risk patients presenting with ACS. The Biolimus-A9–coated stent currently has the best supporting evidence for this indication,” he said.
“This was the last chance for bare metal stents to show a good indication. They were thought to be good only in high–bleeding risk patients. Now we see that a drug-coated stent provides better efficacy and is even safer,” the cardiologist continued.
Leaders Free was a randomized double-blind clinical trial in which 2,499 patients at high risk of bleeding who underwent PCI received either the DCS or the Gazelle bare-metal stent (BMS) and 1 month of dual-antiplatelet therapy. The main results, in which the DCS showed superior safety and efficacy at 12 months of follow-up, have been published (N Engl J Med. 2015 Nov 19;373[21]:2038-47).
Dr. Naber presented a prespecified subgroup analysis that included the 659 Leaders Free participants who presented with ACS.
The primary efficacy endpoint – the 12-month rate of clinically driven target lesion revascularization – was 3.9% in the DCS group, compared with 9% in patients randomized to the BMS, for an adjusted 59% relative risk reduction.
The composite safety endpoint was composed of the 1-year rate of cardiac death, acute MI, and definite or probable stent thrombosis. This occurred in 9.3% of the DCS- and 18.5% of the BMS-treated patients, for a relative risk reduction of 52%.
The BioFreedom stent has a selectively microstructured surface coated with Biolimus-A9, a drug that’s far more lipophilic than sirolimus, everolimus, or zotarolimus. As a result, 98% of the drug is transferred to the plaque-laden vessel within 30 days, which is why it’s safe to shorten DAPT to 1 month, Dr. Naber explained.
It’s estimated that up to 20% of patients undergoing PCI are at high bleeding risk for various reasons.
The DCS is marketed in Europe and in clinical trials in the United States aimed at getting Food and Drug Administration approval.
Discussant Dr. Thomas Cuisset of Timone Hospital in Marseille, France, agreed that “in 2016, bare-metal stents are no longer the gold standard in patients at high bleeding risk.”
He added that the Leaders Free ACS substudy leaves unanswered two major remaining questions: What’s the optimal duration of DAPT for DCS in non-ACS patients at high bleeding risk – is 1 month of DAPT as safe as 6 months? And how do contemporary drug-eluting, polymer-based stents compare to the BioFreedom stent for PCI in the setting of high bleeding risk?
In an interview, Dr. Naber said that before a head-to-head comparative clinical trial can even be considered, there will need to be evidence that drug-eluting stents are safe with shortened DAPT. That has yet to be shown.
The study was funded by Biosensors. Dr. Naber reported receiving consultant’s fees from that medical device company and several others. Dr. Cuisset serves as a consultant to or paid lecturer for more than a dozen medical companies.
Simultaneous with Dr. Naber’s presentation at EuroPCR in Paris, the Leaders Free ACS substudy results were published online (Eur Heart J. doi:10.1093/eurheartj/ehw203).
PARIS – In patients at high bleeding risk undergoing percutaneous coronary intervention for acute coronary syndrome, a unique drug-coated, polymer-free stent backed by just a single month of dual-antiplatelet therapy (DAPT) trounced a bare metal stent in both efficacy and safety at 1 year in a large randomized trial, Dr. Christoph K. Naber reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
The BioFreedom stent, coated with a proprietary sirolimus analogue called Biolimus-A9, rapidly transfers the drug to the vessel wall, leaving in place a metallic stent. This drug-coated stent (DCS) provides the antirestenotic benefits of a drug-eluting stent with the advantages of a shorter DAPT requirement and no potential polymer-related adverse events. The device’s performance in this prespecified subgroup analysis of the Leaders Free trial will be practice altering, predicted Dr. Naber of Elisabeth University Hospital in Essen, Germany.
“We believe that current guidelines and clinical practice need to change. Bare-metal stents can no longer be recommended for high–bleeding risk patients presenting with ACS. The Biolimus-A9–coated stent currently has the best supporting evidence for this indication,” he said.
“This was the last chance for bare metal stents to show a good indication. They were thought to be good only in high–bleeding risk patients. Now we see that a drug-coated stent provides better efficacy and is even safer,” the cardiologist continued.
Leaders Free was a randomized double-blind clinical trial in which 2,499 patients at high risk of bleeding who underwent PCI received either the DCS or the Gazelle bare-metal stent (BMS) and 1 month of dual-antiplatelet therapy. The main results, in which the DCS showed superior safety and efficacy at 12 months of follow-up, have been published (N Engl J Med. 2015 Nov 19;373[21]:2038-47).
Dr. Naber presented a prespecified subgroup analysis that included the 659 Leaders Free participants who presented with ACS.
The primary efficacy endpoint – the 12-month rate of clinically driven target lesion revascularization – was 3.9% in the DCS group, compared with 9% in patients randomized to the BMS, for an adjusted 59% relative risk reduction.
The composite safety endpoint was composed of the 1-year rate of cardiac death, acute MI, and definite or probable stent thrombosis. This occurred in 9.3% of the DCS- and 18.5% of the BMS-treated patients, for a relative risk reduction of 52%.
The BioFreedom stent has a selectively microstructured surface coated with Biolimus-A9, a drug that’s far more lipophilic than sirolimus, everolimus, or zotarolimus. As a result, 98% of the drug is transferred to the plaque-laden vessel within 30 days, which is why it’s safe to shorten DAPT to 1 month, Dr. Naber explained.
It’s estimated that up to 20% of patients undergoing PCI are at high bleeding risk for various reasons.
The DCS is marketed in Europe and in clinical trials in the United States aimed at getting Food and Drug Administration approval.
Discussant Dr. Thomas Cuisset of Timone Hospital in Marseille, France, agreed that “in 2016, bare-metal stents are no longer the gold standard in patients at high bleeding risk.”
He added that the Leaders Free ACS substudy leaves unanswered two major remaining questions: What’s the optimal duration of DAPT for DCS in non-ACS patients at high bleeding risk – is 1 month of DAPT as safe as 6 months? And how do contemporary drug-eluting, polymer-based stents compare to the BioFreedom stent for PCI in the setting of high bleeding risk?
In an interview, Dr. Naber said that before a head-to-head comparative clinical trial can even be considered, there will need to be evidence that drug-eluting stents are safe with shortened DAPT. That has yet to be shown.
The study was funded by Biosensors. Dr. Naber reported receiving consultant’s fees from that medical device company and several others. Dr. Cuisset serves as a consultant to or paid lecturer for more than a dozen medical companies.
Simultaneous with Dr. Naber’s presentation at EuroPCR in Paris, the Leaders Free ACS substudy results were published online (Eur Heart J. doi:10.1093/eurheartj/ehw203).
AT EUROPCR 2016
Key clinical point: There are no longer any good indications for implanting a bare-metal stent.
Major finding: The cumulative 1-year rate of cardiac death, MI, or definite or probable stent thrombosis in high–bleeding risk patients who underwent PCI for acute coronary syndrome was 9.3% in those randomized to a novel drug-coated stent, compared with 18.5% in those who got a bare-metal stent.
Data source: This was a prespecified subgroup analysis of the Leaders Free trial in which 659 acute coronary syndrome patients with high bleeding risk undergoing PCI for acute coronary syndrome were randomized to a unique drug-coated, polymer-free stent or a bare-metal stent, with 1 month of dual-antiplatelet therapy for all.
Disclosures: The study was funded by Biosensors. The presenter reported receiving consultant fees from that medical device company and several others.
