Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial
Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial
复制标题
DOI：
10.1093/eurheartj/ehv481
复制
发表时间：
2016-01-21
影响因子：
39.3
通讯作者：
Vicaut, Eric
中科院分区：
文献类型：
--
作者：
Helft, Gerard;Steg, Philippe Gabriel;Vicaut, Eric
目的 这项开放标签、随机、多中心试验检验了以下假设：在阿司匹林背景下，在药物洗脱支架 (DES) 植入后 12 个月继续服用氯吡格雷优于停止服用氯吡格雷。 方法和结果 因稳定性冠状动脉疾病或急性冠状动脉综合征而接受 >= 1 DES 治疗的患者 (N = 1799) 被纳入 58 个法国研究中心（1 月）。 2009 年至 2013 年 1 月）。无重大心脑血管事件或大出血且支架置入后 12 个月服用阿司匹林和氯吡格雷的患者 (N = 1385) 符合随机化 (1:1) 方案，即继续每天服用 75 mg 氯吡格雷（延长双重抗血小板治疗，DAPT 组）或停用氯吡格雷（阿司匹林组）。主要结局是净不良临床事件，定义为死亡、心肌梗死、中风或大出血的复合事件。随机分组后计划进行至少 6 个月至最长 36 个月的随访。由于招募缓慢，该研究在计划招募 1966 名患者中的 1385 名后停止。支架置入术后的中位随访时间为 33.4 个月。主要结局发生在延长 DAPT 组的 40 名患者（5.8%）和阿司匹林组的 52 名患者（7.5%；风险比 0.75，95% 置信区间 0.50-1.28；P = 0.17）。延长 DAPT 组的死亡率为 2.3%，阿司匹林组的死亡率为 3.5%（HR 0.65，95% CI 0.34-1.22；P = 0.18）。大出血发生率相同（2.0%，P = 0.95）。 结论 与 DES 放置后 12 个月的 DAPT 相比，延长 DAPT 在减少净不良临床事件方面并未取得优势。然而，OPTIDUAL 试验的效力较低，并且由于提前终止入组而降低了效力。
Aim This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation.Methods and results Patients (N = 1799) who had undergone placement of >= 1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009-January 2013). Patients (N = 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1: 1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50-1.28; P = 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34-1.22; P = 0.18). Rates of major bleeding were identical (2.0%, P = 0.95).Conclusions Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment.