双联与三联抗栓治疗用于行经皮冠状动脉介入治疗的伴有或不伴有急性冠状动脉综合征的心房颤动患者的安全性和有效性：基于新型口服抗凝剂的随机临床试验的协作荟萃分析。

AIMS: Safety and efficacy of antithrombotic regimens in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) may differ based on clinical presentation. We sought to compare double vs. triple antithrombotic therapy (DAT vs. TAT) in AF patients with or without acute coronary syndrome (ACS) undergoing PCI. METHODS AND RESULTS: A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials. Data on subgroups of ACS or elective PCI were obtained by published reports or trial investigators. A total of 10 193 patients from four NOAC trials were analysed, of whom 5675 presenting with ACS (DAT = 3063 vs. TAT = 2612) and 4518 with stable coronary artery disease (SCAD; DAT = 2421 vs. TAT = 2097). The primary safety endpoint of ISTH major bleeding or clinically relevant non-major bleeding was reduced with DAT compared with TAT in both ACS (12.2% vs. 19.4%; RR 0.63, 95% CI 0.56-0.71; P < 0.0001; I2 = 0%) and SCAD (14.6% vs. 22.0%; RR 0.68, 95% CI 0.55-0.85; P = 0.0008; I2 = 66%), without interaction (P-int = 0.54). Findings were consistent for secondary bleeding endpoints, including intra-cranial haemorrhage. In both subgroups, there was no difference between DAT and TAT for all-cause death, major adverse cardiovascular events, or stroke. Myocardial infarction and stent thrombosis were numerically higher with DAT vs. TAT consistently in ACS and SCAD (P-int = 0.60 and 0.86, respectively). Findings were confirmed by multiple sensitivity analyses, including a separate analysis on dabigatran regimens and a restriction to PCI population. CONCLUSIONS: DAT, compared with TAT, is associated with lower bleeding risks, including intra-cranial haemorrhage, and a small non-significant excess of cardiac ischaemic events in both patients with or without ACS.

目的：在接受经皮冠状动脉介入治疗（PCI）的心房颤动（AF）患者中，基于临床特征，抗栓治疗方案的安全性和疗效可能不同。我们旨在比较伴有或不伴有急性冠状动脉综合征（ACS）的 AF 患者接受 PCI 时双联 vs. 三联抗栓治疗（DAT vs. TAT）的疗效。

方法和结果：我们使用 PubMed 进行了系统评价和荟萃分析，以搜索非维生素 K 拮抗剂口服抗凝剂（NOAC）为基础的随机临床试验。通过已发表的报告或试验研究者获得 ACS 或择期 PCI 亚组的数据。对来自四项 NOAC 试验的 10193 例患者进行了分析，其中 5675 例患者表现为 ACS（DAT = 3063 例，TAT = 2612 例），4518 例患者为稳定型冠状动脉疾病（SCAD；DAT = 2421 例，TAT = 2097 例）。与 TAT 相比，DAT 降低了 ACS（12.2% vs. 19.4%；RR 0.63，95%CI 0.56-0.71；P < 0.0001；I2 = 0%）和 SCAD（14.6% vs. 22.0%；RR 0.68，95%CI 0.55-0.85；P = 0.0008；I2 = 66%）患者的 ISTH 主要出血或临床相关非大出血主要安全性终点事件发生率（P 交互 = 0.54）。次要出血终点事件，包括颅内出血，也存在一致的结果。在这两个亚组中，DAT 与 TAT 相比，全因死亡率、主要不良心血管事件或卒中等均无差异。ACS 和 SCAD 中，DAT 与 TAT 相比，心肌梗死和支架血栓形成的发生率也呈上升趋势，但无统计学意义（P 交互 = 0.60 和 0.86）。通过多项敏感性分析证实了这一结果，包括对达比加群方案的单独分析和对 PCI 人群的限制。

结论：与 TAT 相比，DAT 可降低出血风险，包括颅内出血，且伴有或不伴有 ACS 的患者的心脏缺血事件发生率略有升高，但无统计学意义。