Background:The REDUAL PCI trial (Evaluation of Dual Therapy With Dabigatran vs Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting) demonstrated that, in patients with atrial fibrillation following percutaneous coronary intervention, bleeding risk was lower with dabigatran plus clopidogrel or ticagrelor (dual therapy) than warfarin plus clopidogrel or ticagrelor and aspirin (triple therapy). Dual therapy was noninferior for risk of thromboembolic events. Whether these results apply equally to patients at higher risk of ischemic events due to lesion complexity or clinical risk factors is unclear.Methods:The primary end point was time to first major or clinically relevant nonmajor bleeding event. The composite efficacy end point was death, thromboembolic event, or unplanned revascularization. Our prespecified subgroup analysis categorized patients by presence of procedural complexity and/or clinical complexity factors at baseline. A modified dual antiplatelet therapy score categorized patients according to degree of clinical risk.Results:Of 2725 patients, 43.1% had clinical complexity factors alone, 9.9% procedural factors alone, 10.0% both, and 37.0% neither. Risk of the primary bleeding end point was lower in both dabigatran dual therapy groups than warfarin triple therapy groups, regardless of procedural and/or clinical lesion complexity (interaction P values: 0.90 and 0.37, respectively). Importantly, a similar risk of the efficacy end point was observed between dabigatran dual and warfarin triple therapy, regardless of the presence of clinical or procedural complexity factors (interaction P values: 0.67 and 0.54, dabigatran 110 and 150 mg dual therapy, respectively). Similar benefit was seen for each dose of dabigatran dual therapy for bleeding events regardless of dual antiplatelet therapy score (interaction P values: 0.53 and 0.54, respectively), with similar risk of thromboembolic events (interaction P values: 0.20 and 0.08, respectively).Conclusions:In patients with atrial fibrillation undergoing percutaneous coronary intervention, dabigatran 110 and 150 mg dual therapy reduced bleeding risk compared with warfarin triple therapy, with a similar risk of thromboembolic outcomes, irrespective of procedural and/or clinical complexity and modified dual antiplatelet therapy score.Registration:URL: https://clinicaltrials.gov/; Unique identifier: NCT02164864.

中文翻译：

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病变复杂度和临床危险因素对达比加群双重疗法与华法林三次疗法在经皮冠状动脉介入治疗后房颤中的疗效和安全性的影响

背景：REDUAL PCI试验（对接受支架置入PCI的房颤患者进行达比加群酯双重疗法与华法林双重疗法的评估）表明，在经皮冠状动脉介入治疗后发生房颤的患者中，达比加群联合氯吡格雷可降低出血风险或替卡格雷（双重疗法）比华法林加氯吡格雷或替卡格雷和阿司匹林（三联疗法）。双重疗法在血栓栓塞事件的发生率方面不逊色。目前尚不清楚这些结果是否同样适用于因病变复杂性或临床危险因素而导致的缺血事件风险较高的患者。方法：主要终点是发生首次重大或临床相关的非重大出血事件的时间。综合功效终点为死亡，血栓栓塞事件或计划外的血运重建。我们预先设定的亚组分析通过基线时程序复杂性和/或临床复杂性因素的存在对患者进行了分类。结果：在2725例患者中，仅43.1％的患者具有临床复杂性因素，仅9.9％的患者具有程序性因素，两者均为10.0％，两者均无37.0％。无论程序和/或临床病变的复杂性如何，达比加群双重治疗组的两次止血终点风险均比华法林三次治疗组低 单独有9％的程序因素，两者均为10.0％，两者都不为37.0％。无论程序和/或临床病变的复杂性如何，达比加群双重治疗组的两次止血终点风险均比华法林三次治疗组低 单独有9％的程序因素，两者均为10.0％，两者都不为37.0％。无论程序和/或临床病变的复杂性如何，达比加群双重治疗组的两次止血终点风险均比华法林三次治疗组低P值：分别为0.90和0.37）。重要的是，无论是否存在临床或程序复杂性因素，达比加群双重疗法和华法林三次疗法之间均观察到疗效终点的相似风险（相互作用P值：0.67和0.54，达比加群110和150 mg双重疗法）。不论双重抗血小板治疗评分如何，达比加群双重疗法针对出血事件的每剂剂量均具有相似的获益（相互作用P值分别为0.53和0.54），血栓栓塞事件的风险也相似（相互作用P结论：在接受经皮冠状动脉介入治疗的房颤患者中，达比加群110和150 mg双重疗法与华法林三联疗法相比，出血风险降低，血栓栓塞结局风险相似，无论手术和/或或临床复杂性和改良的双重抗血小板治疗评分。注册：URL：https：//clinicaltrials.gov/; 唯一标识符：NCT02164864。