Division of Cardiology, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
JAMA Cardiol. 2020 May 1;5(5):582-589. doi: 10.1001/jamacardio.2019.6175.
IMPORTANCE: Antithrombotic treatment in patients with atrial fibrillation (AF) and percutaneous coronary intervention (PCI) presents a balancing act with regard to bleeding and ischemic risks. OBJECTIVES: To evaluate the safety and efficacy of 4 antithrombotic regimens by conducting an up-to-date network meta-analysis and to identify the optimal treatment for patients with AF undergoing PCI. DATA SOURCES: Online computerized database (MEDLINE). STUDY SELECTION: Five randomized studies were included (N = 11 542; WOEST, PIONEER AF-PCI, RE-DUAL PCI, AUGUSTUS, ENTRUST-AF PCI). DATA EXTRACTION AND SYNTHESIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used in this network meta-analysis, in which bayesian random-effects models were applied. The data were analyzed from September 9 to 29, 2019. MAIN OUTCOMES AND MEASURES: The primary safety outcome was thrombolysis in myocardial infarction (TIMI) major bleeding and the primary efficacy outcome was trial-defined major adverse cardiovascular events (MACE). RESULTS: The total number of participants included in the study was 11 532. The mean age of the participants ranged from 70 to 72 years, 69% to 83% were male, 20% to 26% were female, and the participants were predominantly white (>90%). Compared with vitamin K antagonists (VKA) plus dual antiplatelet therapy (DAPT) (reference), the odds ratios (ORs) (95% credible intervals) for TIMI major bleeding were 0.57 (0.31-1.00) for VKA plus P2Y12 inhibitor, 0.69 (0.40-1.16) for non-VKA oral anticoagulant (NOAC) plus DAPT, and 0.52 (0.35-0.79) for NOAC plus P2Y12 inhibitor. For MACE, using VKA plus DAPT as reference, the ORs (95% credible intervals) were 0.97 (0.64-1.42) for VKA plus P2Y12 inhibitor, 0.95 (0.64-1.39) for NOAC plus DAPT, and 1.03 (0.77-1.38) for NOAC plus P2Y12 inhibitor. CONCLUSIONS AND RELEVANCE: The findings of this study suggest that an antithrombotic regimen of VKA plus DAPT should generally be avoided, because regimens in which aspirin is discontinued may lead to lower bleeding risk and no difference in antithrombotic effectiveness. The use of a NOAC plus a P2Y12 inhibitor without aspirin may be the most favorable treatment option and the preferred antithrombotic regimen for most patients with AF undergoing PCI.
重要性：在患有心房颤动（AF）和经皮冠状动脉介入治疗（PCI）的患者中，抗血栓治疗在出血和缺血风险方面存在平衡问题。
目的：通过进行最新的网络荟萃分析来评估 4 种抗血栓治疗方案的安全性和疗效，并确定接受 PCI 的 AF 患者的最佳治疗方法。
数据来源：在线计算机数据库（MEDLINE）。
研究选择：纳入了 5 项随机研究（N=11542；WOEST、PIONEER AF-PCI、RE-DUAL PCI、AUGUSTUS、ENTRUST-AF PCI）。
数据提取与综合：本网络荟萃分析遵循系统评价和荟萃分析的首选报告项目（PRISMA）指南，其中应用了贝叶斯随机效应模型。数据于 2019 年 9 月 9 日至 29 日进行分析。
主要结局和测量指标：主要安全性结局是心肌梗死溶栓治疗（TIMI）大出血，主要疗效结局是试验定义的主要心血管不良事件（MACE）。
结果：本研究共纳入 11532 名参与者。参与者的平均年龄在 70 岁至 72 岁之间，69%至 83%为男性，20%至 26%为女性，且参与者主要为白人（>90%）。与维生素 K 拮抗剂（VKA）加双联抗血小板治疗（DAPT）（参考）相比，TIMI 大出血的优势比（OR）（95%可信区间）分别为 VKA 加 P2Y12 抑制剂（0.57[0.31-1.00]）、非 VKA 口服抗凝剂（NOAC）加 DAPT（0.69[0.40-1.16]）和 NOAC 加 P2Y12 抑制剂（0.52[0.35-0.79]）。对于 MACE，以 VKA 加 DAPT 为参考，VKA 加 P2Y12 抑制剂（0.97[0.64-1.42]）、NOAC 加 DAPT（0.95[0.64-1.39]）和 NOAC 加 P2Y12 抑制剂（1.03[0.77-1.38]）的 OR 相似。
结论和相关性：本研究结果表明，一般应避免使用 VKA 加 DAPT 的抗血栓治疗方案，因为停用阿司匹林的方案可能会降低出血风险，而不会影响抗血栓效果。不使用阿司匹林的 NOAC 加 P2Y12 抑制剂可能是最有利的治疗选择，也是大多数接受 PCI 的 AF 患者的首选抗血栓治疗方案。
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