Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
JACC Cardiovasc Interv. 2018 Apr 9;11(7):626-634. doi: 10.1016/j.jcin.2017.11.009. Epub 2018 Mar 14.
This study sought to assess whether there were significant interactions of procedural access strategies and lesion characteristics with bleeding and ischemic events among atrial fibrillation (AF) patients anticoagulated with rivaroxaban or warfarin following a percutaneous coronary intervention.
Among stented AF patients, the impact of procedural access strategies or lesion characteristics on antithrombotic safety and efficacy outcomes is unclear.
In the PIONEER AF-PCI (An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention) trial, 2,124 patients were randomized to 3 groups and followed for 12 months: 1) rivaroxaban 15 mg once daily plus a P2Y inhibitor (n = 709); 2) rivaroxaban 2.5 mg twice a day plus dual antiplatelet therapy (DAPT) (n = 709); and 3) dose-adjusted warfarin plus DAPT (n = 706). Kaplan-Meier rates of clinically significant bleeding and major adverse cardiovascular events were compared between treatments stratified by subgroups of procedure type and lesion characteristics.
Compared with warfarin, both rivaroxaban regimens consistently reduced clinically significant bleeding across subgroups of radial versus femoral arterial access and by vascular closure device use. Treatment effect of rivaroxaban on major adverse cardiovascular events did not vary when stratified by ischemia-driven revascularization, urgency of revascularization, location of culprit artery, presence of bifurcation lesion, presence of thrombus, type, and length of stent or number of stents (interaction p > 0.05 for all subgroups).
Among stented AF patients requiring long-term oral anticoagulation, there was no effect modification by procedure or lesion characteristics of either clinically significant bleeding or major adverse cardiovascular events. Rivaroxaban-based therapy was superior to warfarin plus DAPT in bleeding outcomes regardless of the type of stent or arterial access during the index coronary revascularization. (A Study Exploring Two Strategies of Rivaroxaban [JNJ39039039; BAY-59-7939] and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [PIONEER AF-PCI]; NCT01830543).
本研究旨在评估在接受经皮冠状动脉介入治疗（PCI）的房颤（AF）患者中，与 rivaroxaban 或华法林抗凝治疗相关的操作方法和病变特征是否与出血和缺血事件存在显著交互作用。
在接受支架置入的 AF 患者中，操作方法或病变特征对抗血栓安全性和疗效结局的影响尚不清楚。
在 PIONEER AF-PCI（一项在接受经皮冠状动脉介入治疗的房颤患者中探索两种 rivaroxaban 治疗策略和一种剂量调整的口服维生素 K 拮抗剂治疗策略的开放性、随机、对照、多中心研究）试验中，2124 例患者被随机分为 3 组，随访 12 个月：1）rivaroxaban 15mg 每日 1 次加 P2Y 抑制剂（n=709）；2）rivaroxaban 2.5mg 每日 2 次加双重抗血小板治疗（DAPT）（n=709）；和 3）剂量调整的华法林加 DAPT（n=706）。根据手术类型和病变特征的亚组，比较不同治疗组之间的临床显著出血和主要不良心血管事件的 Kaplan-Meier 发生率。
与华法林相比，两种 rivaroxaban 方案在经桡动脉或股动脉入路以及使用血管闭合装置时，均能降低临床显著出血的发生率，且亚组之间的差异具有统计学意义。当根据缺血驱动的血运重建、血运重建的紧迫性、罪犯动脉位置、分叉病变存在、血栓存在、支架类型和长度或支架数量（所有亚组的交互 p 值>0.05）进行分层时，rivaroxaban 治疗对主要不良心血管事件的治疗效果无差异。
在需要长期口服抗凝治疗的接受支架置入的 AF 患者中，操作方法或病变特征对临床显著出血或主要不良心血管事件无影响修饰作用。无论在指数冠状动脉血运重建期间使用何种类型的支架或动脉入路，rivaroxaban 为基础的治疗在出血结局方面均优于华法林加 DAPT。（一项在接受经皮冠状动脉介入治疗的房颤患者中探索两种 rivaroxaban [JNJ39039039；BAY-59-7939] 和一种口服维生素 K 拮抗剂策略的研究 [PIONEER AF-PCI]；NCT01830543）。
