SAN FRANCISCO, CA – October 31, 2013 – According to a new study, patients that do not experience a major cardiac event in the first year after receiving drug-eluting stent (DES) may not need to receive prolonged dual antiplatelet therapy (DAPT). Results from the ARCTIC-INTERRUPTION trial were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
The optimal length of time for DAPT after coronary stenting remains uncertain with an unknown safety to efficacy ratio of prolonged therapy. Currently there are discrepancies between international guidelines and high variability in routine practice. The ARCTIC-INTERRUPTION study was a prospective randomized trial that examined the benefit of the continuation of DAPT for up to two years.
ARCTIC-INTERRUPTION randomly assigned 1,259 patients without major events within the first year after coronary stenting to either a strategy of interruption of DAPT (n=624), or a strategy of continuation for an additional year (n=635). The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization after one year.
The primary endpoint occurred in 3.8 percent of patients in the continuation group, as compared to 4.3 percent in the interruption group. The main secondary endpoint of stent thrombosis or any urgent revascularization occurred in 1.3 percent of patients in the continuation group and 1.6 percent of those in the interruption group. The rate of major bleeding events occurred in 1.1 percent of the patients in the continuation group compared to 0.2 percent in the interruption group.
"The ARCTIC-INTERRUPTION study suggests no ischemic benefit of DAPT continuation beyond one year after stenting in patients that do not experience an adverse event within the first year," said lead investigator Gilles Montalescot, MD, PhD. Dr. Montalescot is Professor of Cardiology at Centre Hospitalier Universitaire Pitié-Salpêtrière in Paris, France.
"Further, the study found significantly more major and minor bleeding events with DAPT continuation."
The ARCTIC-INTERRUPTION trial was sponsored by the ACTION study group. Dr. Montalescot reported research grants to the institution or consulting/lecture fees from Abbott Vascular, Accumetrics, AstraZeneca, Bayer, Biotronik, BMS, Boehringer-Ingelheim, Daiichi-Sankyo, Duke Institute, Eli Lilly and Company, Europa, Fédération Française de Cardiologie, Fondation de France, GSK, INSERM, Institut de France, Iroko, Lead-up, Menarini, Medtronic, Nanospheres, Novartis, Pfizer, ReCor Medical, Roche, Sanofi-Aventis, Stentys, Société Française de Cardiologie, Springer, The Medicines Company, The TIMI group, WebMD, and Wolters.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Celebrating its 25th anniversary this year, TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit http://www.crf.org and http://www.tctconference.com.
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