Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Ludwigshafen, Germany.
EuroIntervention. 2021 Aug 27;17(6):474-480. doi: 10.4244/EIJ-D-20-00799.
Little is known about the optimal antithrombotic therapy in patients with atrial fibrillation undergoing PCI for ST-elevation myocardial infarction (STEMI).
The aim of this study was to investigate the safety and efficacy of dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) versus warfarin triple therapy in patients with atrial fibrillation and STEMI.
In the RE-DUAL PCI trial, 305 patients with STEMI were randomised to dabigatran 110 mg (n=113 versus 106 warfarin) or 150 mg (n=86 versus 84 warfarin). The primary endpoint was the time to first major/clinically relevant non-major bleeding event (MBE/CRNMBE). The thrombotic endpoint was a composite of death, thromboembolic events, or unplanned revascularisation.
In STEMI patients, dabigatran 110 mg (HR 0.39, 95% CI: 0.20-0.74) and 150 mg (0.43, 0.21-0.89) dual therapy reduced the risk of MBE/CRNMBE versus warfarin triple therapy (p for interaction vs all other patients=0.31 and 0.16). The risk of thrombotic events for dabigatran 110 mg (HR 1.61, 95% CI: 0.85-3.08) and 150 mg (0.56, 0.20-1.51) had p interactions of 0.20 and 0.33, respectively. For net clinical benefit, the HRs were 0.74 (95% CI: 0.46-1.17) and 0.49 (0.27-0.91) for dabigatran 110 and 150 mg (p for interaction=0.80 and 0.12), respectively.
After PCI for STEMI, patients on dabigatran dual therapy had lower risks of bleeding events versus warfarin triple therapy with similar risks of thromboembolic events, supporting dabigatran dual therapy even in patients with high thrombotic risk.
在接受经皮冠状动脉介入治疗（PCI）的 ST 段抬高型心肌梗死（STEMI）合并心房颤动患者中，抗栓治疗的最佳选择尚不清楚。
本研究旨在探讨达比加群双重治疗（110 或 150 mg，每日 2 次，加用氯吡格雷或替格瑞洛）与华法林三联治疗在合并 STEMI 的心房颤动患者中的安全性和疗效。
在 RE-DUAL PCI 试验中，305 例 STEMI 患者被随机分配至达比加群 110 mg 组（n=113 例，与华法林组 106 例比较）或 150 mg 组（n=86 例，与华法林组 84 例比较）。主要终点是首次主要/临床相关非大出血事件（MBE/CRNMBE）的时间。血栓形成终点是死亡、血栓栓塞事件或计划外血运重建的复合终点。
在 STEMI 患者中，达比加群 110 mg（HR 0.39，95%CI：0.20-0.74）和 150 mg（0.43，0.21-0.89）双重治疗与华法林三联治疗相比降低了 MBE/CRNMBE 的风险（p 交互作用值分别为 0.31 和 0.16）。达比加群 110 mg（HR 1.61，95%CI：0.85-3.08）和 150 mg（0.56，0.20-1.51）的血栓形成事件风险的 p 交互作用值分别为 0.20 和 0.33。对于净临床获益，达比加群 110 mg 和 150 mg 的 HR 分别为 0.74（95%CI：0.46-1.17）和 0.49（95%CI：0.27-0.91）（p 交互作用值分别为 0.80 和 0.12）。
在 STEMI 后行 PCI 的患者中，与华法林三联治疗相比，达比加群双重治疗的出血事件风险较低，而血栓栓塞事件风险相似，这支持即使在高血栓形成风险的患者中也可使用达比加群双重治疗。
