A 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, RESET Investigators, 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, RESET Investigators
Abstract
Objectives: The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation.
Background: There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation.
Methods: We 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.
Results: The 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).
Conclusions: E-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.
Source: PubMed