Background:Among stented patients with atrial fibrillation, double therapy with a novel oral anticoagulant plus single antiplatelet therapy (SAPT) reduces bleeding or cardiovascular rehospitalizations compared with a vitamin K antagonist (VKA) based triple therapy regimen. A recent study demonstrated that apixaban based double therapy reduced bleeding compared with VKA based double therapy. However, it remains unknown whether rivaroxaban based double therapy is superior to a VKA based double therapy.Methods:Patient with stented atrial fibrillation (n=2124) were randomized to 3 groups: rivaroxaban 15 mg od plus a P2Y₁₂ inhibitor (Group 1, n=709); rivaroxaban 2.5 mg bid plus dual antiplatelet therapy (DAPT; Group 2, n=709); and warfarin plus DAPT (Group 3, n=706). Before randomization, subjects were stratified according to a prespecified duration of DAPT (1, 6, or 12 months). After the prespecified DAPT duration, subjects in Group 2 were switched to rivaroxaban 15 mg plus low dose aspirin, and those in Group 3 were switched to VKA plus low dose aspirin. The Wei, Lin, and Weissfeld time to multiple events method was used to compare the occurrence of all bleeding and cardiovascular rehospitalizations among subjects on a novel oral anticoagulant versus VKA based double therapy.Results:A total of 906 subjects were prespecified to a 1 or 6 months DAPT duration and received at least one dose of study drug. Twenty subjects (3.3%) assigned to novel oral anticoagulant+SAPT, and 15 (5.1%) subjects assigned to VKA+SAPT experienced multiple rehospitalizations. In total, 124 (20.3%) events occurred among subjects on novel oral anticoagulant+SAPT compared with 87 (29.6%) among subjects on VKA+SAPT (hazard ratio=0.65 [95% CI, 0.45–0.93], P=0.008).Conclusions:Among stented patients with atrial fibrillation, rivaroxaban plus SAPT was superior to warfarin plus SAPT in lowering total bleeding and cardiovascular rehospitalization.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01830543.

中文翻译：

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新型基于口服抗凝剂和基于维生素K拮抗剂的双重疗法在支架治疗的房颤患者中的双重治疗：来自PIONEER AF-PCI试验的见解。

背景：在有房颤的支架置入患者中，与基于维生素K拮抗剂（VKA）的三联疗法相比，采用新型口服抗凝剂加单抗血小板疗法（SAPT）的双重疗法可减少出血或心血管再住院。最近的一项研究表明，与基于VKA的双重疗法相比，基于apixaban的双重疗法可减少出血。然而，利伐沙班双重疗法是否优于VKA双重疗法尚无定论。方法：将有支架心房颤动的患者（n = 2124）随机分为3组：利伐沙班15 mg od加P2Y ₁₂抑制剂（第1组，n = 709）; 利伐沙班2.5 mg bid加双重抗血小板治疗（DAPT；第2组，n = 709）；和华法林加DAPT（第3组，n = 706）。在随机分组之前，根据DAPT的预定持续时间（1、6或12个月）对受试者进行分层。在预定的DAPT时间后，将第2组的受试者切换为利伐沙班15 mg加低剂量阿司匹林，而第3组的受试者切换为VKA加小剂量阿司匹林。采用Wei，Lin和Weissfeld多事件时间方法比较了新型口服抗凝剂和基于VKA的双重疗法在受试者中所有出血和心血管再入院的发生率。结果：总共906名受试者被指定为1或1。 DAPT持续时间为6个月，并接受了至少一剂研究药物。二十门科目（3。3％的患者被分配给新型口服抗凝剂+ SAPT，而15名（5.1％）的患者被分配给VKA + SAPT进行了多次住院治疗。使用新型口服抗凝剂+ SAPT的受试者总共发生124（20.3％）事件，而使用VKA + SAPT的受试者总共发生87（29.6％）事件（危险比= 0.65 [95％CI，0.45-0.93]，P = 0.008）。结论：在有房颤的支架置入患者中，利伐沙班加SAPT在降低总出血和心血管再住院方面优于华法林加SAPT。临床试验注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT01830543。