TCT 2015

BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.

“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.

Dr. Patterson had no relevant disclosures.

dchitnis@frontlinemedcom.com

BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.

“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.

Dr. Patterson had no relevant disclosures.

dchitnis@frontlinemedcom.com

BOSTON – When performing pneumonectomy on patients with benign disease, it is important to be aware of specific preexisting conditions that could complicate surgery before bringing patients into the operating room.

“Sometimes the usual, standard operative procedure is not appropriate, given the circumstances of a particular patient, [and] typically, these pneumonectomies for benign disease are very challenging operations because the inflamed lung is usually quite densely adherent to the inside of the chest cavity,” explained Dr. G. Alex Patterson of Washington University in St. Louis.

In an interview at the Focus on Thoracic Surgery: Technical Challenges and Complications meeting sponsored by the American Association for Thoracic Surgeons, Dr. Patterson talked about the challenges associated with pneumonectomies for benign disease and how surgeons can safely navigate them.

Dr. Patterson had no relevant disclosures.

dchitnis@frontlinemedcom.com

SAN FRANCISCO – Drug-coated balloons have become a widely used option in Europe for treating coronary in-stent restenosis, and the scoring-balloon pretreatment tested in ISAR-DESIRE 4 appeared to boost the efficacy of a drug-coated balloon in a clinically meaningful way, Dr. Marco Valgimigli said in an interview at the Transcatheter Cardiovascular Therapeutics annual meeting.

When patients develop restenosis within a coronary stent, many times it’s because the stent was not properly expanded during initial placement. An advantage to a drug-coated balloon is that it pairs well with therapeutic reexpansion of the existing stent to its proper, fully open position.

In addition, this approach spares the patient from receiving a second stent inside the first stent, said Dr. Valgimigli, an interventional cardiologist at Inselspital in Bern, Switzerland.

Often when patients develop in-stent restenosis, it tends to keep recurring. And when that happens, eventually the only remaining option for effective revascularization of the patient’s coronary arteries is coronary bypass surgery.

Pretreating in-stent restenosis with a scoring balloon prior to treatment with a drug-coated balloon improved efficacy in the ISAR-DESIRE 4 trial by a modest amount. But if this treatment strategy can successfully defer or obviate just a few cases that might otherwise require coronary bypass surgery, then using the scoring balloon is a reasonable approach, Dr. Valgimigli said at the meeting, sponsored by the Cardiovascular Research Foundation.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Drug-coated balloons have become a widely used option in Europe for treating coronary in-stent restenosis, and the scoring-balloon pretreatment tested in ISAR-DESIRE 4 appeared to boost the efficacy of a drug-coated balloon in a clinically meaningful way, Dr. Marco Valgimigli said in an interview at the Transcatheter Cardiovascular Therapeutics annual meeting.

When patients develop restenosis within a coronary stent, many times it’s because the stent was not properly expanded during initial placement. An advantage to a drug-coated balloon is that it pairs well with therapeutic reexpansion of the existing stent to its proper, fully open position.

In addition, this approach spares the patient from receiving a second stent inside the first stent, said Dr. Valgimigli, an interventional cardiologist at Inselspital in Bern, Switzerland.

Often when patients develop in-stent restenosis, it tends to keep recurring. And when that happens, eventually the only remaining option for effective revascularization of the patient’s coronary arteries is coronary bypass surgery.

Pretreating in-stent restenosis with a scoring balloon prior to treatment with a drug-coated balloon improved efficacy in the ISAR-DESIRE 4 trial by a modest amount. But if this treatment strategy can successfully defer or obviate just a few cases that might otherwise require coronary bypass surgery, then using the scoring balloon is a reasonable approach, Dr. Valgimigli said at the meeting, sponsored by the Cardiovascular Research Foundation.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Drug-coated balloons have become a widely used option in Europe for treating coronary in-stent restenosis, and the scoring-balloon pretreatment tested in ISAR-DESIRE 4 appeared to boost the efficacy of a drug-coated balloon in a clinically meaningful way, Dr. Marco Valgimigli said in an interview at the Transcatheter Cardiovascular Therapeutics annual meeting.

When patients develop restenosis within a coronary stent, many times it’s because the stent was not properly expanded during initial placement. An advantage to a drug-coated balloon is that it pairs well with therapeutic reexpansion of the existing stent to its proper, fully open position.

In addition, this approach spares the patient from receiving a second stent inside the first stent, said Dr. Valgimigli, an interventional cardiologist at Inselspital in Bern, Switzerland.

Often when patients develop in-stent restenosis, it tends to keep recurring. And when that happens, eventually the only remaining option for effective revascularization of the patient’s coronary arteries is coronary bypass surgery.

Pretreating in-stent restenosis with a scoring balloon prior to treatment with a drug-coated balloon improved efficacy in the ISAR-DESIRE 4 trial by a modest amount. But if this treatment strategy can successfully defer or obviate just a few cases that might otherwise require coronary bypass surgery, then using the scoring balloon is a reasonable approach, Dr. Valgimigli said at the meeting, sponsored by the Cardiovascular Research Foundation.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – The safety and efficacy of transcatheter aortic valve replacement keeps improving, with 1-year follow-up now available for two most-advanced systems on the U.S. market showing unprecedentedly low mortality and stroke rates in high-risk patients.

Continued improvements in safety and efficacy had cardiologists declaring that transcatheter aortic valve replacement (TAVR) is now the preferred strategy over surgery.

TAVR “should have a class I indication for high-risk patients as an alternative to surgery. That change needs to be made” based on the new data reported at the Transcatheter Cardiovascular Therapeutics annual meeting, said Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy of Columbia University in New York. TAVR currently has a class IIa recommendation as a “reasonable alternative” to surgery in patients at high surgical risk in the latest U.S. recommendations for treating aortic stenosis that came out in 2014.

One-year follow-up of 492 high-risk or inoperable patients who underwent TAVR with the SAPIEN 3 device system – the newest model from the SAPIEN series of TAVR systems and one of two next-generation systems now on the U.S. market – showed a 14% overall mortality rate and 2% stroke rate, Dr. Howard C. Herrmann reported at the meeting sponsored by the Cardiovascular Research Foundation. A combination of factors likely explained these strikingly low rates, including more refined patient selection, new device features, improved placement techniques, and more extensive operator experience, said Dr. Herrmann, professor and director of the cardiac catheterization laboratory at the University of Pennsylvania in Philadelphia.

The 1-year mortality rate of 14% in the SAPIEN3 (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve) study ran roughly half the rate seen in the large-scale test of the first-generation SAPIEN TAVR system, a study that began nearly 10 years ago (N Engl J Med. 2011 Jun 9;364[23]:2187-98). The 30-day results from this unblinded series of more than 500 patients treated with the SAPIEN 3 system, reported last Spring, led to Food and Drug Administration approval of the SAPIEN 3 system for U.S. marketing last June.“Our confidence in calling TAVR the preferred strategy just gets stronger when we have data like these,” commented Dr. Jeffrey J. Popma, professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston.

“The data show that TAVR is getting better,” said Dr. Samir Kapadia, professor and head of interventional cardiology at the Cleveland Clinic in Cleveland.

Similar 1-year results, though from many fewer patients, also came out at the meeting for the other next-generation TAVR system on the U.S. market, Evolut R, also approved by the FDA last June. Those data showed a 1-year mortality rate of 7% and a disabling stroke rate of 3% among 60 patients who had been treated with the Evolut R TAVR system.

Another notable finding from the SAPIEN 3 results was a moderate paravalvular leak (PVL) rate of 3% after 30 days and 4% after 1 year. No patients had a severe PVL at either 30 days or 1 year; the mild PVL rate at 1 year was 34%, and 62% had none or trace PVL. “The PVL rates are really dramatic,” commented Dr. Popma.

An analysis that correlated PVL severity at 30 days and mortality at 1 year showed that mild PVL linked with 14% mortality, essentially identical to the 12% mortality in patients with no or trace PVL after 30 days. In contrast, the 16 patients with moderate PVL after 30 days had a substantially increased 38% 1-year mortality, highlighting a patient subset that needs additional interventions.

“We need to look at these cases carefully” and determine what issues are causing more severe PVLs, said Dr. Herrmann. “We need to have no moderate PVLs.”

SAPIEN3 was sponsored by Edwards Lifesciences. Dr. Herrmann has received honoraria and research grants from Edwards as well as research grants from several other companies. He also own equity in Microinterventional Devices. Dr. Popma has been a consultant to Abbott Laboratories, Boston Scientific, and STENTYS, and he has been a speaker for Medtronic, Abbott Laboratories, Boston Scientific, Covidien, Cook Medical, and Direct Flow. Dr. Leon has been a consultant to Edwards. Dr. Kapadia had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – The safety and efficacy of transcatheter aortic valve replacement keeps improving, with 1-year follow-up now available for two most-advanced systems on the U.S. market showing unprecedentedly low mortality and stroke rates in high-risk patients.

Continued improvements in safety and efficacy had cardiologists declaring that transcatheter aortic valve replacement (TAVR) is now the preferred strategy over surgery.

TAVR “should have a class I indication for high-risk patients as an alternative to surgery. That change needs to be made” based on the new data reported at the Transcatheter Cardiovascular Therapeutics annual meeting, said Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy of Columbia University in New York. TAVR currently has a class IIa recommendation as a “reasonable alternative” to surgery in patients at high surgical risk in the latest U.S. recommendations for treating aortic stenosis that came out in 2014.

One-year follow-up of 492 high-risk or inoperable patients who underwent TAVR with the SAPIEN 3 device system – the newest model from the SAPIEN series of TAVR systems and one of two next-generation systems now on the U.S. market – showed a 14% overall mortality rate and 2% stroke rate, Dr. Howard C. Herrmann reported at the meeting sponsored by the Cardiovascular Research Foundation. A combination of factors likely explained these strikingly low rates, including more refined patient selection, new device features, improved placement techniques, and more extensive operator experience, said Dr. Herrmann, professor and director of the cardiac catheterization laboratory at the University of Pennsylvania in Philadelphia.

The 1-year mortality rate of 14% in the SAPIEN3 (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve) study ran roughly half the rate seen in the large-scale test of the first-generation SAPIEN TAVR system, a study that began nearly 10 years ago (N Engl J Med. 2011 Jun 9;364[23]:2187-98). The 30-day results from this unblinded series of more than 500 patients treated with the SAPIEN 3 system, reported last Spring, led to Food and Drug Administration approval of the SAPIEN 3 system for U.S. marketing last June.“Our confidence in calling TAVR the preferred strategy just gets stronger when we have data like these,” commented Dr. Jeffrey J. Popma, professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston.

“The data show that TAVR is getting better,” said Dr. Samir Kapadia, professor and head of interventional cardiology at the Cleveland Clinic in Cleveland.

Similar 1-year results, though from many fewer patients, also came out at the meeting for the other next-generation TAVR system on the U.S. market, Evolut R, also approved by the FDA last June. Those data showed a 1-year mortality rate of 7% and a disabling stroke rate of 3% among 60 patients who had been treated with the Evolut R TAVR system.

Another notable finding from the SAPIEN 3 results was a moderate paravalvular leak (PVL) rate of 3% after 30 days and 4% after 1 year. No patients had a severe PVL at either 30 days or 1 year; the mild PVL rate at 1 year was 34%, and 62% had none or trace PVL. “The PVL rates are really dramatic,” commented Dr. Popma.

An analysis that correlated PVL severity at 30 days and mortality at 1 year showed that mild PVL linked with 14% mortality, essentially identical to the 12% mortality in patients with no or trace PVL after 30 days. In contrast, the 16 patients with moderate PVL after 30 days had a substantially increased 38% 1-year mortality, highlighting a patient subset that needs additional interventions.

“We need to look at these cases carefully” and determine what issues are causing more severe PVLs, said Dr. Herrmann. “We need to have no moderate PVLs.”

SAPIEN3 was sponsored by Edwards Lifesciences. Dr. Herrmann has received honoraria and research grants from Edwards as well as research grants from several other companies. He also own equity in Microinterventional Devices. Dr. Popma has been a consultant to Abbott Laboratories, Boston Scientific, and STENTYS, and he has been a speaker for Medtronic, Abbott Laboratories, Boston Scientific, Covidien, Cook Medical, and Direct Flow. Dr. Leon has been a consultant to Edwards. Dr. Kapadia had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – The safety and efficacy of transcatheter aortic valve replacement keeps improving, with 1-year follow-up now available for two most-advanced systems on the U.S. market showing unprecedentedly low mortality and stroke rates in high-risk patients.

Continued improvements in safety and efficacy had cardiologists declaring that transcatheter aortic valve replacement (TAVR) is now the preferred strategy over surgery.

TAVR “should have a class I indication for high-risk patients as an alternative to surgery. That change needs to be made” based on the new data reported at the Transcatheter Cardiovascular Therapeutics annual meeting, said Dr. Martin B. Leon, director of the Center for Interventional Vascular Therapy of Columbia University in New York. TAVR currently has a class IIa recommendation as a “reasonable alternative” to surgery in patients at high surgical risk in the latest U.S. recommendations for treating aortic stenosis that came out in 2014.

One-year follow-up of 492 high-risk or inoperable patients who underwent TAVR with the SAPIEN 3 device system – the newest model from the SAPIEN series of TAVR systems and one of two next-generation systems now on the U.S. market – showed a 14% overall mortality rate and 2% stroke rate, Dr. Howard C. Herrmann reported at the meeting sponsored by the Cardiovascular Research Foundation. A combination of factors likely explained these strikingly low rates, including more refined patient selection, new device features, improved placement techniques, and more extensive operator experience, said Dr. Herrmann, professor and director of the cardiac catheterization laboratory at the University of Pennsylvania in Philadelphia.

The 1-year mortality rate of 14% in the SAPIEN3 (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve) study ran roughly half the rate seen in the large-scale test of the first-generation SAPIEN TAVR system, a study that began nearly 10 years ago (N Engl J Med. 2011 Jun 9;364[23]:2187-98). The 30-day results from this unblinded series of more than 500 patients treated with the SAPIEN 3 system, reported last Spring, led to Food and Drug Administration approval of the SAPIEN 3 system for U.S. marketing last June.“Our confidence in calling TAVR the preferred strategy just gets stronger when we have data like these,” commented Dr. Jeffrey J. Popma, professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston.

“The data show that TAVR is getting better,” said Dr. Samir Kapadia, professor and head of interventional cardiology at the Cleveland Clinic in Cleveland.

Similar 1-year results, though from many fewer patients, also came out at the meeting for the other next-generation TAVR system on the U.S. market, Evolut R, also approved by the FDA last June. Those data showed a 1-year mortality rate of 7% and a disabling stroke rate of 3% among 60 patients who had been treated with the Evolut R TAVR system.

Another notable finding from the SAPIEN 3 results was a moderate paravalvular leak (PVL) rate of 3% after 30 days and 4% after 1 year. No patients had a severe PVL at either 30 days or 1 year; the mild PVL rate at 1 year was 34%, and 62% had none or trace PVL. “The PVL rates are really dramatic,” commented Dr. Popma.

An analysis that correlated PVL severity at 30 days and mortality at 1 year showed that mild PVL linked with 14% mortality, essentially identical to the 12% mortality in patients with no or trace PVL after 30 days. In contrast, the 16 patients with moderate PVL after 30 days had a substantially increased 38% 1-year mortality, highlighting a patient subset that needs additional interventions.

“We need to look at these cases carefully” and determine what issues are causing more severe PVLs, said Dr. Herrmann. “We need to have no moderate PVLs.”

SAPIEN3 was sponsored by Edwards Lifesciences. Dr. Herrmann has received honoraria and research grants from Edwards as well as research grants from several other companies. He also own equity in Microinterventional Devices. Dr. Popma has been a consultant to Abbott Laboratories, Boston Scientific, and STENTYS, and he has been a speaker for Medtronic, Abbott Laboratories, Boston Scientific, Covidien, Cook Medical, and Direct Flow. Dr. Leon has been a consultant to Edwards. Dr. Kapadia had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Food and Drug Administration approval of the SAPIEN XT transcatheter aortic valve for the valve-in-valve indication in high–surgical risk patients means that, officially, there are now two options for transcatheter replacement of a faulty prosthetic aortic valve.

CoreValve, the competing device for transcatheter aortic valve replacement (TAVR) in U.S. practice, received FDA approval for the valve-in-valve indication in March.

Mitchel L. Zoler/Frontline Medical News

Researchers reported the data behind SAPIEN XT’s approval from two U.S. registries with a total of 197 high-risk patients at the Transcatheter Cardiovascular Therapeutics annual meeting on Oct. 16, the same day the FDA approval was announced by Edwards Lifesciences. The mortality rate was 4% after 30 days and 13% after 1 year, and the 1-year stroke rate was 4%, Dr. Danny Dvir said at the meeting.

One feature of the 1-year survival data that Dr. Dvir called “quite amazing” was the absence of any deaths during the first 30 days post TAVR with the SAPIEN XT system, and 7% at 1 year among the 100 patients treated during the final 8 months of the registry, who comprised the second half of patients enrolled in the registry. “I think we learned how to choose the right patients for this procedure,” said Dr. Dvir, an interventional cardiologist at St. Paul’s Hospital in Vancouver, B.C.

Mitchel L. Zoler/Frontline Medical News

Given the risk from replacing a failed bioprosthetic valve by open surgery, “TAVR is becoming the preferred approach to valve-in-valve,” commented Dr. Ajay J. Kirtane, director of the cardiac catheterization laboratories at Columbia University in New York.

The registry results also highlighted a key limitation of the SAPIEN XT valve: patients with a bioprosthetic valve with a relatively narrow inner diameter of 21 mm or less.

Because the SAPIEN series of valves are balloon expandable and designed to sit directly in the aortic-valve annulus, the inner diameter of an existing bioprothesis can limit the TAVR options. The CoreValve, self-expanding valves sit in a supravalvular location and better fit through a narrow-frame existing valve.

This geometric limitation means that SAPIEN XT cannot work in patients with existing valves less than 21 mm in inner diameter, and the registry excluded such patients, who generally comprise about 10% of all patients with severe aortic stenosis.

In addition, among the 28% of patients enrolled in the registry who had an existing valve diameter of 21 mm, the 1-year mortality rate was strikingly high – 20% – compared with an 11% mortality rate in patients with existing valve diameters of 23 or 25 mm, Dr. Dvir reported.

Mitchel L. Zoler/Frontline Medical News

“If a patient had a smaller inner diameter I’d definitely go with the supravalvular valve. For a bigger valve you have more choices,” commented Dr. Axel H.P. Linke, codirector of cardiology at the Heart Center at the University of Leipzig (Germany).

“It’s not fair to extrapolate these findings with SAPIEN XT to smaller [existing bioprosthetic] valves. There is the ability to go to lower inner diameters” using CoreValve, commented Dr. Jeffrey J. Popma, who led the U.S. CoreValve studies and is professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston.

Mitchel L. Zoler/Frontline Medical News

The two sequential valve-in-valve U.S. registries for SAPIEN XT ran as part of the PARTNER 2 trial, designed to test the safety and efficacy of SAPIEN XT in patients undergoing TAVR for a de novo aortic valve. The 197 patients in the full registry averaged 79 years of age, 60% were men, their average Society of Thoracic Surgeons mortality risk score was 9.7%, 50% had atrial fibrillation, 95% had New York Heart Association class III or IV symptoms, and baseline screening identified one-third of the patients as frail.

The PARTNER 2 trial valve-in-valve registry and extended registry are sponsored by Edwards Lifesciences, which markets the SAPIEN XT system. Dr. Dvir has been a consultant to Edwards and to Medtronic, the company that markets the CoreValve systems. Dr. Kirtane has received research grants from Boston Scientific, St. Jude, Eli Lilly, GlaxoSmithKline, Abiomed, and Abbott Vascular. Dr. Linke has been a consultant to Boston Scientific, St. Jude, Bard, Edwards, and Medtronic and owns equity in Claret. Dr. Popma has been principal investigator of the CoreValve studies, has been a consultant to Abbott Vascular, Boston Scientific, and Director Flow; he owns equity in Direct Flow, and he has received research grants from Abbott Vascular, Medtronic, Boston Scientific, and Cook Medical.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Food and Drug Administration approval of the SAPIEN XT transcatheter aortic valve for the valve-in-valve indication in high–surgical risk patients means that, officially, there are now two options for transcatheter replacement of a faulty prosthetic aortic valve.

CoreValve, the competing device for transcatheter aortic valve replacement (TAVR) in U.S. practice, received FDA approval for the valve-in-valve indication in March.

Mitchel L. Zoler/Frontline Medical News

Researchers reported the data behind SAPIEN XT’s approval from two U.S. registries with a total of 197 high-risk patients at the Transcatheter Cardiovascular Therapeutics annual meeting on Oct. 16, the same day the FDA approval was announced by Edwards Lifesciences. The mortality rate was 4% after 30 days and 13% after 1 year, and the 1-year stroke rate was 4%, Dr. Danny Dvir said at the meeting.

One feature of the 1-year survival data that Dr. Dvir called “quite amazing” was the absence of any deaths during the first 30 days post TAVR with the SAPIEN XT system, and 7% at 1 year among the 100 patients treated during the final 8 months of the registry, who comprised the second half of patients enrolled in the registry. “I think we learned how to choose the right patients for this procedure,” said Dr. Dvir, an interventional cardiologist at St. Paul’s Hospital in Vancouver, B.C.

Mitchel L. Zoler/Frontline Medical News

Given the risk from replacing a failed bioprosthetic valve by open surgery, “TAVR is becoming the preferred approach to valve-in-valve,” commented Dr. Ajay J. Kirtane, director of the cardiac catheterization laboratories at Columbia University in New York.

The registry results also highlighted a key limitation of the SAPIEN XT valve: patients with a bioprosthetic valve with a relatively narrow inner diameter of 21 mm or less.

Because the SAPIEN series of valves are balloon expandable and designed to sit directly in the aortic-valve annulus, the inner diameter of an existing bioprothesis can limit the TAVR options. The CoreValve, self-expanding valves sit in a supravalvular location and better fit through a narrow-frame existing valve.

This geometric limitation means that SAPIEN XT cannot work in patients with existing valves less than 21 mm in inner diameter, and the registry excluded such patients, who generally comprise about 10% of all patients with severe aortic stenosis.

In addition, among the 28% of patients enrolled in the registry who had an existing valve diameter of 21 mm, the 1-year mortality rate was strikingly high – 20% – compared with an 11% mortality rate in patients with existing valve diameters of 23 or 25 mm, Dr. Dvir reported.

Mitchel L. Zoler/Frontline Medical News

“If a patient had a smaller inner diameter I’d definitely go with the supravalvular valve. For a bigger valve you have more choices,” commented Dr. Axel H.P. Linke, codirector of cardiology at the Heart Center at the University of Leipzig (Germany).

“It’s not fair to extrapolate these findings with SAPIEN XT to smaller [existing bioprosthetic] valves. There is the ability to go to lower inner diameters” using CoreValve, commented Dr. Jeffrey J. Popma, who led the U.S. CoreValve studies and is professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston.

Mitchel L. Zoler/Frontline Medical News

The two sequential valve-in-valve U.S. registries for SAPIEN XT ran as part of the PARTNER 2 trial, designed to test the safety and efficacy of SAPIEN XT in patients undergoing TAVR for a de novo aortic valve. The 197 patients in the full registry averaged 79 years of age, 60% were men, their average Society of Thoracic Surgeons mortality risk score was 9.7%, 50% had atrial fibrillation, 95% had New York Heart Association class III or IV symptoms, and baseline screening identified one-third of the patients as frail.

The PARTNER 2 trial valve-in-valve registry and extended registry are sponsored by Edwards Lifesciences, which markets the SAPIEN XT system. Dr. Dvir has been a consultant to Edwards and to Medtronic, the company that markets the CoreValve systems. Dr. Kirtane has received research grants from Boston Scientific, St. Jude, Eli Lilly, GlaxoSmithKline, Abiomed, and Abbott Vascular. Dr. Linke has been a consultant to Boston Scientific, St. Jude, Bard, Edwards, and Medtronic and owns equity in Claret. Dr. Popma has been principal investigator of the CoreValve studies, has been a consultant to Abbott Vascular, Boston Scientific, and Director Flow; he owns equity in Direct Flow, and he has received research grants from Abbott Vascular, Medtronic, Boston Scientific, and Cook Medical.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Food and Drug Administration approval of the SAPIEN XT transcatheter aortic valve for the valve-in-valve indication in high–surgical risk patients means that, officially, there are now two options for transcatheter replacement of a faulty prosthetic aortic valve.

CoreValve, the competing device for transcatheter aortic valve replacement (TAVR) in U.S. practice, received FDA approval for the valve-in-valve indication in March.

Mitchel L. Zoler/Frontline Medical News

Researchers reported the data behind SAPIEN XT’s approval from two U.S. registries with a total of 197 high-risk patients at the Transcatheter Cardiovascular Therapeutics annual meeting on Oct. 16, the same day the FDA approval was announced by Edwards Lifesciences. The mortality rate was 4% after 30 days and 13% after 1 year, and the 1-year stroke rate was 4%, Dr. Danny Dvir said at the meeting.

One feature of the 1-year survival data that Dr. Dvir called “quite amazing” was the absence of any deaths during the first 30 days post TAVR with the SAPIEN XT system, and 7% at 1 year among the 100 patients treated during the final 8 months of the registry, who comprised the second half of patients enrolled in the registry. “I think we learned how to choose the right patients for this procedure,” said Dr. Dvir, an interventional cardiologist at St. Paul’s Hospital in Vancouver, B.C.

Mitchel L. Zoler/Frontline Medical News

Given the risk from replacing a failed bioprosthetic valve by open surgery, “TAVR is becoming the preferred approach to valve-in-valve,” commented Dr. Ajay J. Kirtane, director of the cardiac catheterization laboratories at Columbia University in New York.

The registry results also highlighted a key limitation of the SAPIEN XT valve: patients with a bioprosthetic valve with a relatively narrow inner diameter of 21 mm or less.

Because the SAPIEN series of valves are balloon expandable and designed to sit directly in the aortic-valve annulus, the inner diameter of an existing bioprothesis can limit the TAVR options. The CoreValve, self-expanding valves sit in a supravalvular location and better fit through a narrow-frame existing valve.

This geometric limitation means that SAPIEN XT cannot work in patients with existing valves less than 21 mm in inner diameter, and the registry excluded such patients, who generally comprise about 10% of all patients with severe aortic stenosis.

In addition, among the 28% of patients enrolled in the registry who had an existing valve diameter of 21 mm, the 1-year mortality rate was strikingly high – 20% – compared with an 11% mortality rate in patients with existing valve diameters of 23 or 25 mm, Dr. Dvir reported.

Mitchel L. Zoler/Frontline Medical News

“If a patient had a smaller inner diameter I’d definitely go with the supravalvular valve. For a bigger valve you have more choices,” commented Dr. Axel H.P. Linke, codirector of cardiology at the Heart Center at the University of Leipzig (Germany).

“It’s not fair to extrapolate these findings with SAPIEN XT to smaller [existing bioprosthetic] valves. There is the ability to go to lower inner diameters” using CoreValve, commented Dr. Jeffrey J. Popma, who led the U.S. CoreValve studies and is professor at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston.

Mitchel L. Zoler/Frontline Medical News

The two sequential valve-in-valve U.S. registries for SAPIEN XT ran as part of the PARTNER 2 trial, designed to test the safety and efficacy of SAPIEN XT in patients undergoing TAVR for a de novo aortic valve. The 197 patients in the full registry averaged 79 years of age, 60% were men, their average Society of Thoracic Surgeons mortality risk score was 9.7%, 50% had atrial fibrillation, 95% had New York Heart Association class III or IV symptoms, and baseline screening identified one-third of the patients as frail.

The PARTNER 2 trial valve-in-valve registry and extended registry are sponsored by Edwards Lifesciences, which markets the SAPIEN XT system. Dr. Dvir has been a consultant to Edwards and to Medtronic, the company that markets the CoreValve systems. Dr. Kirtane has received research grants from Boston Scientific, St. Jude, Eli Lilly, GlaxoSmithKline, Abiomed, and Abbott Vascular. Dr. Linke has been a consultant to Boston Scientific, St. Jude, Bard, Edwards, and Medtronic and owns equity in Claret. Dr. Popma has been principal investigator of the CoreValve studies, has been a consultant to Abbott Vascular, Boston Scientific, and Director Flow; he owns equity in Direct Flow, and he has received research grants from Abbott Vascular, Medtronic, Boston Scientific, and Cook Medical.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Two sirolimus-eluting stents with differing elution an absorption kinetics were equally effective in the prospective, randomized PANDA III trial.

The sirolimus in the BuMA stent is completely absorbed in 3 months, while that in the Excel stent takes 6-9 months to be absorbed.

The target lesion failure rate, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, was the same at 6.4% in 1,175 patients randomized to receive the BuMA device, and 1,175 randomized to receive the Excel device. Cardiac death occurred in 1.2% and 1.3% of patients in the groups, respectively; target vessel myocardial infarction occurred in 4.3% and 4.9%; and ischemia-driven target lesion revascularization occurred in 1.9% and 1.2%, respectively, Dr. Bo Xu of Fu Wai Hospital, Beijing, explained at the Transcatheter Cardiovascular Therapeutics annual meeting.

However, the definite/probable stent thrombosis rate at 1 year was 0.5% in the BuMA patients, and 1.3% in the Excel patients in the intention to treat population. The difference was statistically significant.

BuMA and Excel – neither of which are available in the United States – are both bioresorbable, polymer-based metallic stents, but they have varying elution and absorption kinetics: The BuMA sirolimus-eluting stent (SES) is a poly lactic-co-glycolic acid (PLGA) polymer-based stent incorporating an electrografting base layer between the polymer and stent strut, securing adhesion for the PLGA coating. The BuMA sirolimus is 100% eluted within 30 days, and the polymer is completely absorbed within 3 months, Dr. Xu said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

“In contrast, the [polylactic acid, or PLA] polymer-based Excel SES elutes sirolimus completely within 180 days, and the PLA polymer is completely absorbed within 6-9 months,” he said.

Both stents elute sirolimus from stainless steel platforms, which means that major differences in effects are likely attributable to the polymer and elution kinetics, he noted.

In a previous small study (the BuMA-OCT trial, EuroIntervention 2014;10[7]:806-14) involving 80 patients who were randomized to receive either the BuMA or the Excel stent, the BuMA stent was found to be superior at 3 months (strut coverage proportion, 94.2% vs. 90.0%). The current study enrolled all comers to determine whether BuMA is noninferior or superior to the Excel SES for the primary endpoint of 1 year target lesion failure.

The findings demonstrate noninferiority of the BuMA SES. Further, the BuMA SES was associated with a lower incidence of stent thrombosis, compared with the Excel SES, consistent with the previous findings of enhanced strut coverage with this device, Dr. Xu said, adding that longer follow-up is needed to further understand the long-term effects of this emerging stent technology.

Discussant Dr. David J. Cohen of St. Luke’s Mid America Heart Institute, Kansas City, applauded the study design and inclusion of all comers, but noted that the findings don’t have immediate clinical implications in the United States since neither is available here. They do, however, shed some light on the two stents used in the trial, he said.

“The only difference was stent thrombosis, which was somewhat borderline in the intention-to-treat population, and has to at least be taken as a word of caution. We don’t know if this is because the new stent with the bioabsorbable polymer is better than other things we have, or if the comparator stent is worse, since it’s not a comparator that’s widely used, he said.

Panda III was funded by a research grant from SinoMed. Dr. Xu reported having no disclosures.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Two sirolimus-eluting stents with differing elution an absorption kinetics were equally effective in the prospective, randomized PANDA III trial.

The sirolimus in the BuMA stent is completely absorbed in 3 months, while that in the Excel stent takes 6-9 months to be absorbed.

The target lesion failure rate, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, was the same at 6.4% in 1,175 patients randomized to receive the BuMA device, and 1,175 randomized to receive the Excel device. Cardiac death occurred in 1.2% and 1.3% of patients in the groups, respectively; target vessel myocardial infarction occurred in 4.3% and 4.9%; and ischemia-driven target lesion revascularization occurred in 1.9% and 1.2%, respectively, Dr. Bo Xu of Fu Wai Hospital, Beijing, explained at the Transcatheter Cardiovascular Therapeutics annual meeting.

However, the definite/probable stent thrombosis rate at 1 year was 0.5% in the BuMA patients, and 1.3% in the Excel patients in the intention to treat population. The difference was statistically significant.

BuMA and Excel – neither of which are available in the United States – are both bioresorbable, polymer-based metallic stents, but they have varying elution and absorption kinetics: The BuMA sirolimus-eluting stent (SES) is a poly lactic-co-glycolic acid (PLGA) polymer-based stent incorporating an electrografting base layer between the polymer and stent strut, securing adhesion for the PLGA coating. The BuMA sirolimus is 100% eluted within 30 days, and the polymer is completely absorbed within 3 months, Dr. Xu said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

“In contrast, the [polylactic acid, or PLA] polymer-based Excel SES elutes sirolimus completely within 180 days, and the PLA polymer is completely absorbed within 6-9 months,” he said.

Both stents elute sirolimus from stainless steel platforms, which means that major differences in effects are likely attributable to the polymer and elution kinetics, he noted.

In a previous small study (the BuMA-OCT trial, EuroIntervention 2014;10[7]:806-14) involving 80 patients who were randomized to receive either the BuMA or the Excel stent, the BuMA stent was found to be superior at 3 months (strut coverage proportion, 94.2% vs. 90.0%). The current study enrolled all comers to determine whether BuMA is noninferior or superior to the Excel SES for the primary endpoint of 1 year target lesion failure.

The findings demonstrate noninferiority of the BuMA SES. Further, the BuMA SES was associated with a lower incidence of stent thrombosis, compared with the Excel SES, consistent with the previous findings of enhanced strut coverage with this device, Dr. Xu said, adding that longer follow-up is needed to further understand the long-term effects of this emerging stent technology.

Discussant Dr. David J. Cohen of St. Luke’s Mid America Heart Institute, Kansas City, applauded the study design and inclusion of all comers, but noted that the findings don’t have immediate clinical implications in the United States since neither is available here. They do, however, shed some light on the two stents used in the trial, he said.

“The only difference was stent thrombosis, which was somewhat borderline in the intention-to-treat population, and has to at least be taken as a word of caution. We don’t know if this is because the new stent with the bioabsorbable polymer is better than other things we have, or if the comparator stent is worse, since it’s not a comparator that’s widely used, he said.

Panda III was funded by a research grant from SinoMed. Dr. Xu reported having no disclosures.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Two sirolimus-eluting stents with differing elution an absorption kinetics were equally effective in the prospective, randomized PANDA III trial.

The sirolimus in the BuMA stent is completely absorbed in 3 months, while that in the Excel stent takes 6-9 months to be absorbed.

The target lesion failure rate, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, was the same at 6.4% in 1,175 patients randomized to receive the BuMA device, and 1,175 randomized to receive the Excel device. Cardiac death occurred in 1.2% and 1.3% of patients in the groups, respectively; target vessel myocardial infarction occurred in 4.3% and 4.9%; and ischemia-driven target lesion revascularization occurred in 1.9% and 1.2%, respectively, Dr. Bo Xu of Fu Wai Hospital, Beijing, explained at the Transcatheter Cardiovascular Therapeutics annual meeting.

However, the definite/probable stent thrombosis rate at 1 year was 0.5% in the BuMA patients, and 1.3% in the Excel patients in the intention to treat population. The difference was statistically significant.

BuMA and Excel – neither of which are available in the United States – are both bioresorbable, polymer-based metallic stents, but they have varying elution and absorption kinetics: The BuMA sirolimus-eluting stent (SES) is a poly lactic-co-glycolic acid (PLGA) polymer-based stent incorporating an electrografting base layer between the polymer and stent strut, securing adhesion for the PLGA coating. The BuMA sirolimus is 100% eluted within 30 days, and the polymer is completely absorbed within 3 months, Dr. Xu said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

“In contrast, the [polylactic acid, or PLA] polymer-based Excel SES elutes sirolimus completely within 180 days, and the PLA polymer is completely absorbed within 6-9 months,” he said.

Both stents elute sirolimus from stainless steel platforms, which means that major differences in effects are likely attributable to the polymer and elution kinetics, he noted.

In a previous small study (the BuMA-OCT trial, EuroIntervention 2014;10[7]:806-14) involving 80 patients who were randomized to receive either the BuMA or the Excel stent, the BuMA stent was found to be superior at 3 months (strut coverage proportion, 94.2% vs. 90.0%). The current study enrolled all comers to determine whether BuMA is noninferior or superior to the Excel SES for the primary endpoint of 1 year target lesion failure.

The findings demonstrate noninferiority of the BuMA SES. Further, the BuMA SES was associated with a lower incidence of stent thrombosis, compared with the Excel SES, consistent with the previous findings of enhanced strut coverage with this device, Dr. Xu said, adding that longer follow-up is needed to further understand the long-term effects of this emerging stent technology.

Discussant Dr. David J. Cohen of St. Luke’s Mid America Heart Institute, Kansas City, applauded the study design and inclusion of all comers, but noted that the findings don’t have immediate clinical implications in the United States since neither is available here. They do, however, shed some light on the two stents used in the trial, he said.

“The only difference was stent thrombosis, which was somewhat borderline in the intention-to-treat population, and has to at least be taken as a word of caution. We don’t know if this is because the new stent with the bioabsorbable polymer is better than other things we have, or if the comparator stent is worse, since it’s not a comparator that’s widely used, he said.

Panda III was funded by a research grant from SinoMed. Dr. Xu reported having no disclosures.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.

The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.

The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.

Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.

“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.

The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.

The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.

Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.

The TUXEDO-India trial was supported by Boston Scientific.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.

The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.

The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.

Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.

“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.

The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.

The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.

Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.

The TUXEDO-India trial was supported by Boston Scientific.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Everolimus-eluting stents were more effective than were paclitaxel-eluting stents in diabetes patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) in the randomized, multicenter TUXEDO-India trial.

The everolimus-eluting stents were shown to be superior to paclitaxel-eluting stents on several endpoints, including target-vessel failure, myocardial infarction, and stent thrombosis at 1 year Dr. Upendra Kaul reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Target vessel failure – the study’s primary endpoint, defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization – occurred in 5.6% of 914 patients randomized to the paclitaxel-eluting stent group, compared with 2.9% of 916 randomized to the everolimus-eluting stent group (relative risk, 1.89), Dr. Kaul of Fortis Escorts Heart Institute, New Delhi, reported at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The rate of spontaneous MI was 3.2% vs. 1.2% in the groups, respectively, and the rate of stent thrombosis was 2.1% vs. 0.4%. Target-vessel revascularization and target-lesion revascularization rates in both groups were 3.4% vs. 1.2% with paclitaxel- and everolimus-eluting stents, respectively, he said, noting that the superiority of everolimus-eluting stents was maintained in insulin-requiring patients.

The findings, which were published online simultaneously (N Engl J Med. 2015 Oct. 14;doi: 10.1056/NEJMoa1510188), effectively end the debate regarding whether paclitaxel-eluting stents are the better choice in diabetes patients with coronary artery disease.

Paclitaxel-eluting stents are generally accepted to be inferior to limus-eluting stents in most patients, but data from numerous trials have been conflicting as to whether that is true in diabetes patients.

“In the absence of a dedicated adequately powered study, a definitive answer is not possible,” Dr. Kaul said.

The findings from TUXEDO, the largest trial to compare paclitaxel- and everolimus-eluting stents head to head in diabetes patients, support “the current worldwide practice of use of new-generation limus-eluting stents, even in patients with insulin-requiring diabetes,” he said.

The findings raise questions about the results of prior coronary artery bypass grafting vs. stenting trials that show superiority of CABG, because first-generation stents, which are inferior to everolimus-eluting stents, were used as comparators in those trials, he noted.

Indeed, current guidelines for bypass surgery and PCI are based upon the findings of those trials, and while the TUXEDO findings don’t invalidate those prior studies, they do raise questions about whether the differences in favor of bypass surgery are much smaller than believed in the setting of modern stent use, commented Dr. Bernard J. Gersh of the Mayo Clinic, Rochester, Minn.

The TUXEDO-India trial was supported by Boston Scientific.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Drug-coated balloons are an option in Europe for treating in-stent restenosis in coronary arteries, and new results from a randomized trial with 252 German patients showed that the efficacy of a drug-coated balloon for treating restenosis jumped significantly when preceded by prepping the in-stent restenosis with a scoring-balloon inflation.

“Neointimal modification with a scoring balloon significantly improved the antirestenotic efficacy of a paclitaxel-coated balloon” measured by angiography 6-8 months after the intervention, Dr. Robert A. Byrne said at the at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

Using a scoring balloon first led to an average 35% diameter stenosis in the treated segment at follow-up angiography, compared with a 40% average diameter stenosis at follow-up in patients treated with a paclitaxel-coated balloon alone, without the scoring-balloon first.

“We feel that even this modest increased benefit might be relevant for practice,” said Dr. Byrne, an interventional cardiologist at the German Heart Center in Munich. “This is a challenging patient group, particularly patients who develop restenosis inside a drug-eluting stent. Even small gains are worth pursuing.” All patients enrolled in the study had their restenosis inside a drug-eluting stent.

“It was a modest benefit,” but the alternative to treating in-stent restenosis with a drug-eluting balloon is using a stent, which creates a stent-in-stent situation and has relatively poor outcomes, commented Dr. David J. Cohen, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City. Dr. Cohen noted that, as of now, no drug-coated balloon has received approval for U.S. marketing.

“The most important message was that if you treat in-stent restenosis with a drug-coated balloon, then lesion preparation is the most important step,” commented Dr. Bruno Scheller, professor and interventional cardiologist at the University Clinic of Saarland in Homburg, Germany.

The ISAR-DESIRE 4 (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4) trial enrolled 252 patients with restenosis inside a drug-eluting coronary stent at four German centers during June 2012–December 2014. Patients averaged 69 years old, about 85% were men, and about 42% had diabetes. The study randomized patients to pretreatment with either a scoring balloon or a conventional balloon. After that, all lesions received treatment with a paclitaxel-coated balloon (Pantera Lux).

The study’s primary endpoint was average-diameter stenosis on follow-up angiography 6-8 months after treatment. Scoring balloon pretreatment produced a five percentage-point decline in the diameter stenosis at follow-up. In addition, the secondary outcome of binary restenosis – the percentage of patients with at least 50% diameter stenosis at follow-up – occurred at a 19% rate in the 125 patients pretreated with a scoring balloon and a 32% rate in the 127 control patients pretreated with a conventional balloon, Dr. Byrne reported at the meeting, sponsored by the Cardiovascular Research Foundation.

Scoring-balloon pretreatment also produced a trend toward fewer patients undergoing a new revascularization procedure during 1 year of clinical follow-up, with a 17% revascularization rate among patients pretreated with a scoring balloon and a 23% rate among the controls. The primary safety outcome, the combined rate of death and nonfatal MIs during 1-year clinical follow-up, occurred at an identical 3% rate in both treatment arms.

The ISAR-DESIRE 4 trial was cosponsored by Biotronik, which markets the paclitaxel-coated balloon (Pantera Lux) used in the trial. Dr. Byrne said that he has received speaking fees from Biotronik and from Boston Scientific and B. Braun Melsungen. Dr. Cohen has been a consultant to Abbott Vascular and Medtronic, a speaker for AstraZeneca, and he has received research grants from nine companies. Dr. Scheller has several patents involving drug-coated balloons.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Drug-coated balloons are an option in Europe for treating in-stent restenosis in coronary arteries, and new results from a randomized trial with 252 German patients showed that the efficacy of a drug-coated balloon for treating restenosis jumped significantly when preceded by prepping the in-stent restenosis with a scoring-balloon inflation.

“Neointimal modification with a scoring balloon significantly improved the antirestenotic efficacy of a paclitaxel-coated balloon” measured by angiography 6-8 months after the intervention, Dr. Robert A. Byrne said at the at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

Using a scoring balloon first led to an average 35% diameter stenosis in the treated segment at follow-up angiography, compared with a 40% average diameter stenosis at follow-up in patients treated with a paclitaxel-coated balloon alone, without the scoring-balloon first.

“We feel that even this modest increased benefit might be relevant for practice,” said Dr. Byrne, an interventional cardiologist at the German Heart Center in Munich. “This is a challenging patient group, particularly patients who develop restenosis inside a drug-eluting stent. Even small gains are worth pursuing.” All patients enrolled in the study had their restenosis inside a drug-eluting stent.

“It was a modest benefit,” but the alternative to treating in-stent restenosis with a drug-eluting balloon is using a stent, which creates a stent-in-stent situation and has relatively poor outcomes, commented Dr. David J. Cohen, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City. Dr. Cohen noted that, as of now, no drug-coated balloon has received approval for U.S. marketing.

“The most important message was that if you treat in-stent restenosis with a drug-coated balloon, then lesion preparation is the most important step,” commented Dr. Bruno Scheller, professor and interventional cardiologist at the University Clinic of Saarland in Homburg, Germany.

The ISAR-DESIRE 4 (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4) trial enrolled 252 patients with restenosis inside a drug-eluting coronary stent at four German centers during June 2012–December 2014. Patients averaged 69 years old, about 85% were men, and about 42% had diabetes. The study randomized patients to pretreatment with either a scoring balloon or a conventional balloon. After that, all lesions received treatment with a paclitaxel-coated balloon (Pantera Lux).

The study’s primary endpoint was average-diameter stenosis on follow-up angiography 6-8 months after treatment. Scoring balloon pretreatment produced a five percentage-point decline in the diameter stenosis at follow-up. In addition, the secondary outcome of binary restenosis – the percentage of patients with at least 50% diameter stenosis at follow-up – occurred at a 19% rate in the 125 patients pretreated with a scoring balloon and a 32% rate in the 127 control patients pretreated with a conventional balloon, Dr. Byrne reported at the meeting, sponsored by the Cardiovascular Research Foundation.

Scoring-balloon pretreatment also produced a trend toward fewer patients undergoing a new revascularization procedure during 1 year of clinical follow-up, with a 17% revascularization rate among patients pretreated with a scoring balloon and a 23% rate among the controls. The primary safety outcome, the combined rate of death and nonfatal MIs during 1-year clinical follow-up, occurred at an identical 3% rate in both treatment arms.

The ISAR-DESIRE 4 trial was cosponsored by Biotronik, which markets the paclitaxel-coated balloon (Pantera Lux) used in the trial. Dr. Byrne said that he has received speaking fees from Biotronik and from Boston Scientific and B. Braun Melsungen. Dr. Cohen has been a consultant to Abbott Vascular and Medtronic, a speaker for AstraZeneca, and he has received research grants from nine companies. Dr. Scheller has several patents involving drug-coated balloons.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Drug-coated balloons are an option in Europe for treating in-stent restenosis in coronary arteries, and new results from a randomized trial with 252 German patients showed that the efficacy of a drug-coated balloon for treating restenosis jumped significantly when preceded by prepping the in-stent restenosis with a scoring-balloon inflation.

“Neointimal modification with a scoring balloon significantly improved the antirestenotic efficacy of a paclitaxel-coated balloon” measured by angiography 6-8 months after the intervention, Dr. Robert A. Byrne said at the at the Transcatheter Cardiovascular Therapeutics annual meeting.

Mitchel L. Zoler/Frontline Medical News

Using a scoring balloon first led to an average 35% diameter stenosis in the treated segment at follow-up angiography, compared with a 40% average diameter stenosis at follow-up in patients treated with a paclitaxel-coated balloon alone, without the scoring-balloon first.

“We feel that even this modest increased benefit might be relevant for practice,” said Dr. Byrne, an interventional cardiologist at the German Heart Center in Munich. “This is a challenging patient group, particularly patients who develop restenosis inside a drug-eluting stent. Even small gains are worth pursuing.” All patients enrolled in the study had their restenosis inside a drug-eluting stent.

“It was a modest benefit,” but the alternative to treating in-stent restenosis with a drug-eluting balloon is using a stent, which creates a stent-in-stent situation and has relatively poor outcomes, commented Dr. David J. Cohen, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City. Dr. Cohen noted that, as of now, no drug-coated balloon has received approval for U.S. marketing.

“The most important message was that if you treat in-stent restenosis with a drug-coated balloon, then lesion preparation is the most important step,” commented Dr. Bruno Scheller, professor and interventional cardiologist at the University Clinic of Saarland in Homburg, Germany.

The ISAR-DESIRE 4 (Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4) trial enrolled 252 patients with restenosis inside a drug-eluting coronary stent at four German centers during June 2012–December 2014. Patients averaged 69 years old, about 85% were men, and about 42% had diabetes. The study randomized patients to pretreatment with either a scoring balloon or a conventional balloon. After that, all lesions received treatment with a paclitaxel-coated balloon (Pantera Lux).

The study’s primary endpoint was average-diameter stenosis on follow-up angiography 6-8 months after treatment. Scoring balloon pretreatment produced a five percentage-point decline in the diameter stenosis at follow-up. In addition, the secondary outcome of binary restenosis – the percentage of patients with at least 50% diameter stenosis at follow-up – occurred at a 19% rate in the 125 patients pretreated with a scoring balloon and a 32% rate in the 127 control patients pretreated with a conventional balloon, Dr. Byrne reported at the meeting, sponsored by the Cardiovascular Research Foundation.

Scoring-balloon pretreatment also produced a trend toward fewer patients undergoing a new revascularization procedure during 1 year of clinical follow-up, with a 17% revascularization rate among patients pretreated with a scoring balloon and a 23% rate among the controls. The primary safety outcome, the combined rate of death and nonfatal MIs during 1-year clinical follow-up, occurred at an identical 3% rate in both treatment arms.

The ISAR-DESIRE 4 trial was cosponsored by Biotronik, which markets the paclitaxel-coated balloon (Pantera Lux) used in the trial. Dr. Byrne said that he has received speaking fees from Biotronik and from Boston Scientific and B. Braun Melsungen. Dr. Cohen has been a consultant to Abbott Vascular and Medtronic, a speaker for AstraZeneca, and he has received research grants from nine companies. Dr. Scheller has several patents involving drug-coated balloons.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

SAN FRANCISCO – Recanalization of a chronic total occlusion in a noninfarct-related artery within a week after primary percutaneous coronary intervention was safe and feasible but did not improve overall left ventricular ejection fraction or LV end diastolic volume in the randomized, prospective EXPLORE trial.

At 4 months after primary percutaneous coronary intervention (pPCI), cardiac magnetic resonance imaging showed that left ventricular ejection fraction (LVEF) was similar in 136 patients who underwent chronic total occlusion percutaneous coronary intervention (CTO-PCI) and 144 who did not undergo CTO-PCI (44.1 and 44.8, respectively) within 1 week after the pPCI, Dr. Jose P.S. Henriques reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

LV end diastolic volume also was similar in the two groups (215.6 and 212.8, respectively), Dr. Henriques of the Academic Medical Center, Amsterdam, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

A subgroup analysis, however, showed that LVEF did improve significantly with CTO-PCI in 69 patients whose CTOs were located in the left anterior descending (LAD) artery, compared with 211 patients with non-LAD CTOs (treatment effect, 6.8 vs. –3.2), Dr. Henriques said.

Patients enrolled in the EXPLORE trial had a mean age of 60 years, and most were men (89% in the CTO-PCI group and 82% in the non-CTO-PCI group). The two groups were well balanced with respect to clinical and demographic characteristics. Of note, both groups had a high rate of triple-vessel disease with greater than 70% stenosis and high rates of multiple CTOs (9% and 14%), he said.

Of those who underwent CTO-PCI, 6 had multiple CTO arteries treated, 124 were treated using an antegrade-only technique, 23 were treated using a retrograde technique, and 5 were treated using Crossboss/Stingray. The self-reported PCI success rates was 80%, but this was downgraded to 72% based on core lab adjudication.

About 10% of ST-segment–elevation myocardial infarction (STEMI) patients have a noninfarct-related artery CTO, but randomized controlled data on management are lacking.

“We don’t know how to treat them or what to do with these patients. What we do know is that the observed mortality in multivessel-disease patients vs. single vessel–disease patients is mainly driven by confirmed total occlusion. Also, the observed reduced LV function in multivessel-disease patients vs. single vessel–disease patients is also mainly driven by chronic total occlusion,” Dr. Henriques said.

“The EXPLORE trial is the first randomized controlled trial on the impact of PCI of CTO on LV function and clinical outcome in post-STEMI patients,” he said.

The findings suggest that CTO-PCI for a post-STEMI CTO located in the LAD may improve LV function and potentially improve clinical outcome in the long term, he concluded.

Dr. Henriques reported receiving grant or research support from Abbott Vascular, Abiomed, Biotronik, and B.Braun.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Recanalization of a chronic total occlusion in a noninfarct-related artery within a week after primary percutaneous coronary intervention was safe and feasible but did not improve overall left ventricular ejection fraction or LV end diastolic volume in the randomized, prospective EXPLORE trial.

At 4 months after primary percutaneous coronary intervention (pPCI), cardiac magnetic resonance imaging showed that left ventricular ejection fraction (LVEF) was similar in 136 patients who underwent chronic total occlusion percutaneous coronary intervention (CTO-PCI) and 144 who did not undergo CTO-PCI (44.1 and 44.8, respectively) within 1 week after the pPCI, Dr. Jose P.S. Henriques reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

LV end diastolic volume also was similar in the two groups (215.6 and 212.8, respectively), Dr. Henriques of the Academic Medical Center, Amsterdam, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

A subgroup analysis, however, showed that LVEF did improve significantly with CTO-PCI in 69 patients whose CTOs were located in the left anterior descending (LAD) artery, compared with 211 patients with non-LAD CTOs (treatment effect, 6.8 vs. –3.2), Dr. Henriques said.

Patients enrolled in the EXPLORE trial had a mean age of 60 years, and most were men (89% in the CTO-PCI group and 82% in the non-CTO-PCI group). The two groups were well balanced with respect to clinical and demographic characteristics. Of note, both groups had a high rate of triple-vessel disease with greater than 70% stenosis and high rates of multiple CTOs (9% and 14%), he said.

Of those who underwent CTO-PCI, 6 had multiple CTO arteries treated, 124 were treated using an antegrade-only technique, 23 were treated using a retrograde technique, and 5 were treated using Crossboss/Stingray. The self-reported PCI success rates was 80%, but this was downgraded to 72% based on core lab adjudication.

About 10% of ST-segment–elevation myocardial infarction (STEMI) patients have a noninfarct-related artery CTO, but randomized controlled data on management are lacking.

“We don’t know how to treat them or what to do with these patients. What we do know is that the observed mortality in multivessel-disease patients vs. single vessel–disease patients is mainly driven by confirmed total occlusion. Also, the observed reduced LV function in multivessel-disease patients vs. single vessel–disease patients is also mainly driven by chronic total occlusion,” Dr. Henriques said.

“The EXPLORE trial is the first randomized controlled trial on the impact of PCI of CTO on LV function and clinical outcome in post-STEMI patients,” he said.

The findings suggest that CTO-PCI for a post-STEMI CTO located in the LAD may improve LV function and potentially improve clinical outcome in the long term, he concluded.

Dr. Henriques reported receiving grant or research support from Abbott Vascular, Abiomed, Biotronik, and B.Braun.

sworcester@frontlinemedcom.com

SAN FRANCISCO – Recanalization of a chronic total occlusion in a noninfarct-related artery within a week after primary percutaneous coronary intervention was safe and feasible but did not improve overall left ventricular ejection fraction or LV end diastolic volume in the randomized, prospective EXPLORE trial.

At 4 months after primary percutaneous coronary intervention (pPCI), cardiac magnetic resonance imaging showed that left ventricular ejection fraction (LVEF) was similar in 136 patients who underwent chronic total occlusion percutaneous coronary intervention (CTO-PCI) and 144 who did not undergo CTO-PCI (44.1 and 44.8, respectively) within 1 week after the pPCI, Dr. Jose P.S. Henriques reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

LV end diastolic volume also was similar in the two groups (215.6 and 212.8, respectively), Dr. Henriques of the Academic Medical Center, Amsterdam, said at the meeting, which was sponsored by the Cardiovascular Research Foundation.

A subgroup analysis, however, showed that LVEF did improve significantly with CTO-PCI in 69 patients whose CTOs were located in the left anterior descending (LAD) artery, compared with 211 patients with non-LAD CTOs (treatment effect, 6.8 vs. –3.2), Dr. Henriques said.

Patients enrolled in the EXPLORE trial had a mean age of 60 years, and most were men (89% in the CTO-PCI group and 82% in the non-CTO-PCI group). The two groups were well balanced with respect to clinical and demographic characteristics. Of note, both groups had a high rate of triple-vessel disease with greater than 70% stenosis and high rates of multiple CTOs (9% and 14%), he said.

Of those who underwent CTO-PCI, 6 had multiple CTO arteries treated, 124 were treated using an antegrade-only technique, 23 were treated using a retrograde technique, and 5 were treated using Crossboss/Stingray. The self-reported PCI success rates was 80%, but this was downgraded to 72% based on core lab adjudication.

About 10% of ST-segment–elevation myocardial infarction (STEMI) patients have a noninfarct-related artery CTO, but randomized controlled data on management are lacking.

“We don’t know how to treat them or what to do with these patients. What we do know is that the observed mortality in multivessel-disease patients vs. single vessel–disease patients is mainly driven by confirmed total occlusion. Also, the observed reduced LV function in multivessel-disease patients vs. single vessel–disease patients is also mainly driven by chronic total occlusion,” Dr. Henriques said.

“The EXPLORE trial is the first randomized controlled trial on the impact of PCI of CTO on LV function and clinical outcome in post-STEMI patients,” he said.

The findings suggest that CTO-PCI for a post-STEMI CTO located in the LAD may improve LV function and potentially improve clinical outcome in the long term, he concluded.

Dr. Henriques reported receiving grant or research support from Abbott Vascular, Abiomed, Biotronik, and B.Braun.

sworcester@frontlinemedcom.com