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J. Am. Coll. Cardiol. · Oct 2012
Randomized Controlled Trial Multicenter Study Comparative StudyA new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation).
- Byeong-Keuk Kim, Myeong-Ki Hong, Dong-Ho Shin, Chung-Mo Nam, Jung-Sun Kim, Young-Guk Ko, Donghoon Choi, Tae-Soo Kang, Byoung-Eun Park, Woong-Chol Kang, Seung-Hwan Lee, Jung-Han Yoon, Bum-Kee Hong, Hyuck-Moon Kwon, Yangsoo Jang, and RESET Investigators.
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
- J. Am. Coll. Cardiol. 2012 Oct 9;60(15):1340-8.
ObjectivesThe goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation.BackgroundThere have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation.MethodsWe randomly assigned 2,117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES+3-month DAPT, n=1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n=1,058). We hypothesized that the E-ZES+3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target\vessel revascularization, or bleeding) at 1 year.ResultsThe primary endpoint occurred in 40 (4.7%) patients assigned to E-ZES+3-month DAPT compared with 41 (4.7%) patients assigned to the standard therapy (difference: 0.0%; 95% confidence interval [CI]: -2.5 to 2.5; p=0.84; p<0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8% and 1.3%, respectively (difference: -0.5%; 95% CI: -1.5 to 0.5; p=0.48). The rates of stent thrombosis were 0.2% and 0.3%, respectively (difference: -0.1%; 95% CI: -0.5 to 0.3; p=0.65) without its further occurrence after cessation of clopidogrel in the E-ZES+3-month DAPT group. The rates of target vessel revascularization were 3.9% and 3.7%, respectively (difference: 0.2%; 95% CI: -2.3 to 2.6; p=0.70).ConclusionsE-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079).Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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