St Antonius Ziekenhuis, Nieuwegein, the Netherlands.
French Alliance for Cardiovascular Trials (FACT), Hôpital Bichat, Paris, France; Université de Paris, Paris, France; INSERM U-1148, Paris, France; Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.
Am J Cardiol. 2020 Mar 1;125(5):735-743. doi: 10.1016/j.amjcard.2019.11.029. Epub 2019 Dec 9.
The RE-DUAL PCI trial reported that dabigatran dual therapy (110/150 mg twice daily, plus clopidogrel or ticagrelor) reduced bleeding events versus warfarin triple therapy (warfarin plus aspirin and clopidogrel or ticagrelor) in patients with atrial fibrillation who underwent percutaneous coronary intervention, with noninferiority in composite thromboembolic events. In this prespecified analysis, risks of first major or clinically relevant nonmajor bleeding event and composite end point of death, thromboembolic events, or unplanned revascularization were compared between dabigatran dual therapy and warfarin triple therapy in older (≥ 75 years) and younger (< 75 years) patients, using Cox proportional hazard regression. Of 2,725 patients randomized to treatment, 1,026 (37.7%) were categorized into older and 1,699 (62.3%) into younger age groups. Dabigatran 110 mg dual therapy lowered bleeding risk versus warfarin triple therapy in older (hazard ratio [HR] 0.67; 95% confidence interval [CI] 0.51 to 0.89) and younger patients (HR 0.40; 95% CI 0.30 to 0.54); interaction p value: 0.0125. Dabigatran 150 mg dual therapy lowered bleeding risk versus warfarin triple therapy in younger patients (HR 0.57; 95% CI 0.44 to 0.74), whereas no benefit could be observed in older patients (HR 1.21; 95% CI 0.83 to 1.77); interaction p value: 0.0013. For the thromboembolic end point, there was a trend for a higher risk with dabigatran 110 mg dual therapy in older patients, compared with warfarin triple therapy, whereas the risk was similar in younger patients. For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients. In conclusion, the benefits of dabigatran dual therapy differed in the 2 age groups, which may help dose selection when using dabigatran dual therapy.
RE-DUAL PCI 试验报告称，与华法林三联疗法（华法林+阿司匹林+氯吡格雷或替格瑞洛）相比，达比加群双重疗法（110/150mg，每日两次）可降低接受经皮冠状动脉介入治疗的房颤患者的出血事件风险，且复合血栓栓塞事件无差异。在该预先指定的分析中，使用 Cox 比例风险回归比较了达比加群双重疗法与华法林三联疗法在年龄较大（≥75 岁）和年龄较小（<75 岁）患者中的首次主要或临床相关非主要出血事件和复合终点（死亡、血栓栓塞事件或计划性血运重建）风险。在 2725 名随机接受治疗的患者中，1026 名（37.7%）归入年龄较大组，1699 名（62.3%）归入年龄较小组。达比加群 110mg 双重疗法降低了老年（风险比 [HR]0.67；95%置信区间 [CI]0.51 至 0.89）和年轻患者（HR0.40；95%CI0.30 至 0.54）的出血风险；交互 p 值：0.0125。达比加群 150mg 双重疗法降低了年轻患者的出血风险（HR0.57；95%CI0.44 至 0.74），而在老年患者中未观察到获益（HR1.21；95%CI0.83 至 1.77）；交互 p 值：0.0013。对于血栓栓塞终点，与华法林三联疗法相比，达比加群 110mg 双重疗法在老年患者中呈现出更高风险的趋势，而在年轻患者中风险相似。对于达比加群 150mg 双重疗法，与华法林三联疗法相比，老年和年轻患者的血栓栓塞风险相似。总之，达比加群双重疗法在这两个年龄组中的获益不同，这可能有助于在使用达比加群双重疗法时选择剂量。
