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.
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.
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