Dipartimento Cardio-Toraco-Vascolare, University of Bologna, Italy (T.P., A.G.B., D.D.R., M.L.B.-R.).
Department of Cardiology, Brest University, France (M.G.).
Circ Cardiovasc Interv. 2019 Mar;12(3):e007541. doi: 10.1161/CIRCINTERVENTIONS.118.007541.
We sought to determine whether the risks and benefits of prolonging dual-antiplatelet therapy (DAPT) beyond 1 year after drug-eluting stent implantation depend on clinical presentation in a meta-analysis of randomized controlled trials.
Randomized controlled trials comparing ≤1- versus >1-year DAPT after drug-eluting stent placement were searched through MEDLINE, EMBASE, Cochrane databases, and proceedings of international meetings. The primary efficacy end point was myocardial infarction, whereas the primary safety end point was major bleeding. Net clinical benefit was defined as the composite of myocardial infarction or major bleeding. Outcomes were analyzed according to patient presentation with stable ischemic heart disease versus acute coronary syndromes. The meta-analysis included 6 trials with a total of 21 457 patients, including 14 132 with stable ischemic heart disease and 7325 with acute coronary syndrome. After a median follow-up of 19.5 months, ≤1-year DAPT was associated with higher rates of myocardial infarction compared with >1-year DAPT (hazard ratio [HR], 1.63; 95% CI, 1.37-1.95), with no interaction apparent between treatment effect and clinical presentation. Shorter DAPT was associated with reduced rates of major bleeding compared with longer DAPT (HR, 0.64; 95% CI, 0.42-0.99) with no significant interaction between treatment effect and clinical presentation. However, a net clinical benefit of >1-year DAPT was present in patients with acute coronary syndrome (HR of shorter versus longer DAPT, 1.59; 95% CI, 1.24-2.02) but not in those with stable ischemic heart disease (HR, 1.15; 95% CI, 0.89-1.51; P=0.04). Shorter DAPT was also associated with lower rates of noncardiac mortality compared with longer DAPT (HR, 0.71; 95% CI, 0.52-0.96), with no significant interaction between treatment effect and clinical presentation ( P=0.12).
Compared with ≤1-year DAPT, >1-year DAPT reduces the risk of myocardial infarction but increases the risk of major bleeding and noncardiac mortality. A net clinical benefit of extended DAPT was apparent for patients with acute coronary syndrome but not for those with stable ischemic heart disease.
我们旨在通过对随机对照试验的荟萃分析，确定在药物洗脱支架置入后延长双联抗血小板治疗（DAPT）时间超过 1 年的风险和获益是否取决于临床特征。
通过 MEDLINE、EMBASE、Cochrane 数据库和国际会议记录搜索了比较药物洗脱支架置入后≤1 年与＞1 年 DAPT 的随机对照试验。主要疗效终点为心肌梗死，主要安全性终点为大出血。净临床获益定义为心肌梗死或大出血的复合终点。根据稳定型缺血性心脏病与急性冠状动脉综合征患者的临床表现对结局进行分析。该荟萃分析纳入了 6 项临床试验，共计 21457 例患者，其中 14132 例患有稳定型缺血性心脏病，7325 例患有急性冠状动脉综合征。中位随访 19.5 个月后，与＞1 年 DAPT 相比，≤1 年 DAPT 组心肌梗死发生率更高（风险比[HR]，1.63；95%置信区间[CI]，1.37-1.95），但治疗效果与临床表现之间未见明显交互作用。与较长 DAPT 相比，较短 DAPT 与大出血发生率降低相关（HR，0.64；95%CI，0.42-0.99），但治疗效果与临床表现之间无显著交互作用。然而，急性冠状动脉综合征患者中＞1 年 DAPT 具有净临床获益（较短 DAPT 与较长 DAPT 的 HR，1.59；95%CI，1.24-2.02），但稳定型缺血性心脏病患者中则无（HR，1.15；95%CI，0.89-1.51；P=0.04）。与较长 DAPT 相比，较短 DAPT 与非心脏死亡率降低相关（HR，0.71；95%CI，0.52-0.96），但治疗效果与临床表现之间无显著交互作用（P=0.12）。
与≤1 年 DAPT 相比，＞1 年 DAPT 可降低心肌梗死风险，但增加大出血和非心脏死亡率风险。急性冠状动脉综合征患者中延长 DAPT 具有净临床获益，但稳定型缺血性心脏病患者中则无。
