User login
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
DENVER – Treatment of coronary in-stent restenosis using a paclitaxel-eluting balloon proved noninferior to an everolimus-eluting stent in terms of minimal lumen diameter at 6 months in the DARE trial, Jose P.S. Henriques, MD, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
The two forms of device therapy also yielded similar rates of adverse clinical events, including target vessel revascularization, at 12 months, he said.
The DARE (Drug-Eluting Balloon for In-Stent Restenosis) trial included 278 patients with in-stent restenosis (ISR) randomized to the SeQuent Please paclitaxel-eluting balloon or Xience everolimus-eluting stent at high-volume Dutch percutaneous coronary intervention centers. The trial was unique in that it included a mix of patients with in-stent restenosis involving DES and bare-metal stents. Indeed, 44% of participants had ISR in a bare-metal stent. These older-model stents are still used in patients who require a shorter duration of dual-antiplatelet therapy, so the DARE population reflects real-world clinical practice better than do prior studies restricted to ISR in only one stent type or the other, according to the cardiologist.
The primary outcome in this noninferiority trial was the in-segment minimal lumen diameter at 6-month angiographic follow-up. The mean diameter was 1.71 mm in the drug-eluting balloon (DEB) group and closely similar at 1.74 mm in the DES group. There was greater acute gain with the drug-eluting stent, but it was canceled out by greater late loss by 6 months.
Moreover, the 12-month composite clinical event rate composed of death, target vessel MI, and target vessel revascularization was 10.9% in the DEB recipients and 9.2% with the DES, a nonsignificant difference. Of note, target vessel revascularization occurred in 8.8% of the DEB group and was similar at 7.1% in the DES recipients, although the DARE trial wasn’t powered to detect differences in clinical events.
These results confirm the European Society of Cardiology’s class 1A recommendation for DEB as well as DES for ISR, Dr. Henriques said at the meeting sponsored by the Cardiovascular Research Foundation.
U.S. guidelines don’t address DEB for the treatment of coronary ISR. That’s because the devices, which have long been available in Europe, aren’t approved for use in the coronary tree in the United States. They are available in the United States only for treatment of peripheral vascular disease. And no U.S. clinical trials of DEBs in the coronary tree are planned.
“I wish the U.S. Food and Drug Administration was listening to the DARE results because we really would like to see this technology in the U.S.,” said Roxana Mehran, MD, who moderated a press conference where the DARE findings were highlighted.
David J. Cohen, MD, director of cardiovascular research at Saint Luke’s Mid America Heart Institute in Kansas City, Mo., commented, “This type of device, obviously with it being similar in performance to drug-eluting stents, would be a very welcome addition to our armamentarium, because one of the things I don’t like to do as a coronary interventionalist is to line up multiple stents inside each other.”
“Making club sandwiches out of patients’ arteries with stent after stent is not a good idea. We know that,” added Dr. Mehran, professor of medicine and director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine in New York.
Cindy L. Grines, MD, chair of cardiology at the Hofstra Northwell School of Medicine in Hempstead, N.Y., said DEBs “would absolutely be welcome” if they were available to cardiologists in the United States.
“When you have repeated episodes of in-stent restenosis, you can start with a vessel that’s 3 mm in diameter; then when it restenoses and you place a second stent inside there, all of a sudden – even if you have a great stent result – you can be down to 2.25 mm. And then the next time you need to treat it for restenosis, you’re down to a very tiny lumen. That’s the big problem with trying to treat in-stent restenosis with more stents,” she explained.
The DEBs are expensive, and ISR has become so uncommon with the use of the current generation of drug-eluting stents that the device companies have little incentive to do the studies required to be able to market DEBs in the United States.
“I think the FDA should consider in-stent restenosis as an orphan disease. We really should be able to get a drug-eluting balloon approved in this country based on the data over in Europe,” Dr. Grines said.
Dr. Henriques reported receiving research grants from B. Braun, which markets the paclitaxel-eluting stent in Europe, as well as from Abbott Vascular.
AT TCT 2017
Key clinical point:
Major finding: The mean 6-month in-segment minimal lumen diameter following treatment of in-stent restenosis with a paclitaxel-eluting balloon was 1.71 mm and was similar at 1.74 mm in patients treated using an everolimus-eluting stent.
Data source: A prospective, multicenter Dutch randomized trial including 278 patients with in-stent restenosis.
Disclosures: The study was sponsored by the University of Amsterdam and financially supported by a research grant from B. Braun. The presenter reported receiving research grants from that company and Abbott Vascular.