Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
J Am Coll Cardiol. 2012 Oct 9;60(15):1340-8. doi: 10.1016/j.jacc.2012.06.043. Epub 2012 Sep 19.
The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation.
There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation.
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.
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).
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).
本研究旨在评估药物洗脱支架（DES）置入后较短时间（3 个月）的双联抗血小板治疗（DAPT）。
很少有前瞻性随机临床试验报告比较 DES 置入后较短时间 DAPT 的安全性和有效性。
我们根据 DAPT 持续时间和支架类型将 2117 例冠状动脉狭窄患者随机分为 2 组：依维莫司洗脱支架（E-ZES）植入后 3 个月 DAPT（E-ZES+3 个月 DAPT，n=1059）与其他 DES 植入后 12 个月 DAPT（标准治疗，n=1058）。我们假设 E-ZES+3 个月 DAPT 与标准治疗相比，在 1 年时主要复合终点（心血管死亡、心肌梗死、支架血栓形成、靶血管血运重建或出血）非劣效。
E-ZES+3 个月 DAPT 组有 40（4.7%）例患者发生主要终点事件，标准治疗组有 41（4.7%）例患者发生主要终点事件（差异：0.0%；95%置信区间[CI]：-2.5 至 2.5；p=0.84；p<0.001 用于非劣效性）。任何死亡、心肌梗死或支架血栓形成的复合发生率分别为 0.8%和 1.3%（差异：-0.5%；95%CI：-1.5 至 0.5；p=0.48）。支架血栓形成的发生率分别为 0.2%和 0.3%（差异：-0.1%；95%CI：-0.5 至 0.3；p=0.65），在 E-ZES+3 个月 DAPT 组停止使用氯吡格雷后未再发生支架血栓形成。靶血管血运重建的发生率分别为 3.9%和 3.7%（差异：0.2%；95%CI：-2.3 至 2.6；p=0.70）。
E-ZES+3 个月 DAPT 与标准治疗相比，主要终点事件的发生率无差异。（依维莫司洗脱支架植入后 3 个月双联抗血小板治疗的真实安全性和有效性研究[RESET]；NCT01145079）。
