Deutsches Herzzentrum, Technische Universität, Lazaretstr. 36, Munich, Germany.
Eur Heart J. 2012 Dec;33(24):3078-87. doi: 10.1093/eurheartj/ehs318. Epub 2012 Oct 22.
The aim of this study was to evaluate benefits and risks of extending dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in the drug-eluting stent era.
We searched electronic databases (Medline, EMBASE, the Cochrane Central Register of Controlled Trials), relevant websites, reference lists, conference abstracts, reviews, chapters in books, and proceedings of advisory panels for the US Food and Drug Administration, for randomized controlled trials investigating the clinical impact of extending DAPT duration in patients undergoing PCI. The primary endpoint was all-cause death. The secondary endpoints were myocardial infarction (MI), stent thrombosis (ST), cerebrovascular accidents (CVAs), and thrombolysis in myocardial infarction (TIMI) major bleeding. We included four trials that randomized 8231 patients (50.2%, extended DAPT duration vs. 49.8%, control duration). A total of 8158 patients (99.1%) were available for final analyses. The median DAPT duration was 16.8 vs. 6.2 months for the extended DAPT and control groups, respectively. At follow-up (median 16.8 months) extending DAPT duration did not reduce all-cause death [odds ratio (95% confidence interval) = 1.15 (0.85-1.54), P = 0.36], MI [0.95 (0.66-1.36), P = 0.77], ST [0.88 (0.43-1.81), P = 0.73], or CVAs [1.51 (0.92-2.47), P = 0.10]. Conversely, extended DAPT duration clearly increased the risk of TIMI major bleeding [2.64 (1.31-5.30), P = 0.006].
The extension of DAPT duration after percutaneous coronary interventions may increase the risk of bleeding without reducing ischaemic events. These results need corroboration from large ongoing trials.
本研究旨在评估药物洗脱支架时代经皮冠状动脉介入治疗（PCI）后延长双联抗血小板治疗（DAPT）的获益和风险。
我们检索了电子数据库（Medline、EMBASE、Cochrane 对照试验中心注册库）、相关网站、参考文献列表、会议摘要、综述、书籍章节和美国食品和药物管理局咨询小组的会议记录，以寻找调查 PCI 患者延长 DAPT 持续时间对临床影响的随机对照试验。主要终点是全因死亡。次要终点是心肌梗死（MI）、支架血栓形成（ST）、脑血管意外（CVA）和心肌梗死溶栓治疗（TIMI）大出血。我们纳入了四项随机分配 8231 名患者（50.2%，延长 DAPT 持续时间与 49.8%，对照组）的试验。共有 8158 名患者（99.1%）可进行最终分析。延长 DAPT 组和对照组的 DAPT 中位持续时间分别为 16.8 个月和 6.2 个月。在随访（中位时间 16.8 个月）时，延长 DAPT 持续时间并未降低全因死亡[比值比（95%置信区间）=1.15（0.85-1.54），P=0.36]、MI[0.95（0.66-1.36），P=0.77]、ST[0.88（0.43-1.81），P=0.73]或 CVA[1.51（0.92-2.47），P=0.10]。相反，延长 DAPT 持续时间明显增加 TIMI 大出血的风险[2.64（1.31-5.30），P=0.006]。
经皮冠状动脉介入治疗后延长 DAPT 持续时间可能会增加出血风险，而不会减少缺血事件。这些结果需要来自正在进行的大型试验的证实。
