Department of Cardiac-Thoracic-Vascular Sciences, University of Padova, Via Giustiniani 2, 35128 Padua, Italy.
Department of Cardiology, ISAResearch, German Heart Center, Lazarettstrasse 36, 80636 Munich, Germany.
Eur Heart J. 2021 Jan 21;42(4):308-319. doi: 10.1093/eurheartj/ehaa739.
After percutaneous coronary intervention (PCI) with second-generation drug-eluting stent (DES), whether short dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with a P2Y12 receptor inhibitor confers benefits compared with prolonged DAPT is unclear.
Multiple electronic databases, including PubMed, Scopus, Web of Sciences, Ovid, and ScienceDirect, were searched to identify randomized clinical trials comparing ≤3 months of DAPT followed by P2Y12 inhibitor SAPT vs. 12 months of DAPT after PCI with second-generation DES implantation. The primary and co-primary outcomes of interest were major bleeding and stent thrombosis 1 year after randomization. Summary hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated by fixed-effect and random-effects models. Multiple sensitivity analyses including random-effects models 95% CI adjustment were applied. A sensitivity analysis comparing trials using P2Y12 inhibitor SAPT with those using aspirin SAPT was performed. A total of five randomized clinical trials (32 145 patients) were available. Major bleeding was significantly lower in the patients assigned to short DAPT followed by P2Y12 inhibitor SAPT compared with those assigned to 12-month DAPT (random-effects model: HR 0.63, 95% 0.45-0.86). No significant differences between groups were observed in terms of stent thrombosis (random-effects model: HR 1.19, 95% CI 0.86-1.65) and the secondary endpoints of all-cause death (random-effects model: HR 0.85, 95% CI 0.70-1.03), myocardial infarction (random-effects model: HR 1.05, 95% CI 0.89-1.23), and stroke (random-effects model: HR 1.08, 95% CI 0.68-1.74). Sensitivity analyses showed overall consistent results. By comparing trials testing ≤3 months of DAPT followed by P2Y12 inhibitor SAPT vs. 12 months of DAPT with trials testing ≤3 months of DAPT followed by aspirin SAPT vs. 12-month of DAPT, there was no treatment-by-subgroup interaction for each endpoint. By combining all these trials, regardless of the type of SAPT, short DAPT was associated with lower major bleeding (random-effects model: HR 0.63, 95% CI 0.48-0.83) and no differences in stent thrombosis, all-cause death, myocardial infarction, and stroke were observed between regimens.
After second-generation DES implantation, 1-3 months of DAPT followed by P2Y12 inhibitor SAPT is associated with lower major bleeding and similar stent thrombosis, all-cause death, myocardial infarction, and stroke compared with prolonged DAPT. Whether P2Y12 inhibitor SAPT is preferable to aspirin SAPT needs further investigation.
经第二代药物洗脱支架（DES）经皮冠状动脉介入治疗（PCI）后，短程双联抗血小板治疗（DAPT）后序贯单药抗血小板治疗（SAPT）与延长 DAPT 相比是否更具优势尚不清楚。
通过检索多个电子数据库，包括 PubMed、Scopus、Web of Sciences、Ovid 和 ScienceDirect，以确定比较 PCI 后植入第二代 DES 后≤3 个月 DAPT 加 P2Y12 受体抑制剂 SAPT 与 12 个月 DAPT 的随机临床试验。主要和联合主要结局为随机分组后 1 年的主要出血和支架血栓形成。采用固定效应和随机效应模型估计汇总风险比（HR）和 95%置信区间（CI）。应用了包括随机效应模型 95%CI 调整的多种敏感性分析。对比较使用 P2Y12 抑制剂 SAPT 和使用阿司匹林 SAPT 的试验进行了敏感性分析。共有五项随机临床试验（32145 例患者）符合纳入标准。与接受 12 个月 DAPT 的患者相比，接受短程 DAPT 序贯 P2Y12 抑制剂 SAPT 的患者主要出血显著降低（随机效应模型：HR 0.63，95%CI 0.45-0.86）。两组在支架血栓形成方面无显著差异（随机效应模型：HR 1.19，95%CI 0.86-1.65）和所有原因死亡的次要终点（随机效应模型：HR 0.85，95%CI 0.70-1.03）、心肌梗死（随机效应模型：HR 1.05，95%CI 0.89-1.23）和卒中（随机效应模型：HR 1.08，95%CI 0.68-1.74）。敏感性分析显示整体结果一致。通过比较≤3 个月 DAPT 序贯 P2Y12 抑制剂 SAPT 与 12 个月 DAPT 的试验与≤3 个月 DAPT 序贯阿司匹林 SAPT 与 12 个月 DAPT 的试验，每个终点均无治疗组间相互作用。综合所有这些试验，无论 SAPT 的类型如何，短程 DAPT 与较低的主要出血相关（随机效应模型：HR 0.63，95%CI 0.48-0.83），支架血栓形成、全因死亡、心肌梗死和卒中无差异。
在第二代 DES 植入后，1-3 个月的 DAPT 加 P2Y12 抑制剂 SAPT 与延长 DAPT 相比，主要出血减少，支架血栓形成、全因死亡、心肌梗死和卒中发生率相似。P2Y12 抑制剂 SAPT 是否优于阿司匹林 SAPT 尚需进一步研究。
