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房颤患者PCI术后的达比加群双联抗血栓治疗
Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation


Christopher P. Cannon ... 心脑血管疾病 • 2017.10.19
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房颤合并PCI:双联抗栓治疗时代是否已来临

 

姚焰

中国医学科学院阜外医院心内科

 

冠心病和房颤均是严重危害人类健康的重大公共卫生问题,两者常伴发。调查显示,房颤患者中冠心病的患病率为18%~46.5%,亚临床冠脉疾病高达74% 1。冠心病患者中房颤的患病率为0.2%~5%,而住院的急性冠脉综合征患者中,房颤高达2.4%~21% 2

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摘要


背景

华法林加两种抗血小板药物的三联抗血栓治疗是房颤患者完成经皮冠状动脉介入治疗(PCI)后的标准治疗,但这种治疗与高出血风险相关。

 

方法

在这项多中心试验中,我们随机将2,725例已行PCI术的房颤患者分配到三联疗法,即华法林加上一种P2Y12抑制剂(氯吡格雷或替格瑞洛)和阿司匹林(治疗1~3个月)(三联治疗组),或双联疗法即达比加群(110 mg或150 mg,每日2次)加上一种P2Y12抑制剂(氯吡格雷或替格瑞洛)但无阿司匹林(110 mg和150 mg的双联治疗组)。在美国以外的国家,老年患者(≥80岁,在日本≥70岁)被随机分配到110 mg双联治疗组或三联治疗组。主要终点是随访期间大出血或临床相关的非大出血事件(平均随访时间为14个月)。该试验还测试了达比加群双联疗法(两种剂量的数据合并)相对于华法林三联疗法的非劣效性,评估内容为复合疗效终点的发生率,复合终点包括血栓栓塞事件(心肌梗死、卒中或全身性栓塞)、死亡或计划外血运重建。

 

结果

110 mg双联治疗组的主要终点发生率为15.4%,而三联治疗组为26.9%(风险比,0.52;95%置信区间[CI],0.42~0.63;非劣效性P<0.001,优效性P<0.001);150 mg双联治疗组为20.2%,而相应的三联治疗组(不包括美国以外的老年患者)为25.7%(风险比,0.72;95% CI,0.58~0.88;非劣效性P<0.001)。两个双联治疗组的合并复合疗效终点发生率为13.7%,而三联治疗组为13.4%(风险比,1.04;95% CI,0.84~1.29;非劣效性P=0.005)。不同组别之间严重不良事件发生率差异无统计学意义。

 

结论

在接受了PCI治疗的房颤患者中,接受双联治疗(即达比加群和一种P2Y12抑制剂)的患者出血风险小于接受三联治疗(即华法林、一种P2Y12抑制剂和阿司匹林)的患者。在血栓栓塞事件的风险方面,双联疗法不劣于三联疗法(由勃林格殷格翰公司资助;RE-DUAL PCI在ClinicalTrials.gov注册号为NCT02164864)。





作者信息

Christopher P. Cannon, M.D., Deepak L. Bhatt, M.D., M.P.H., Jonas Oldgren, M.D., Ph.D., Gregory Y.H. Lip, M.D., Stephen G. Ellis, M.D., Takeshi Kimura, M.D., Michael Maeng, M.D., Ph.D., Bela Merkely, M.D., Uwe Zeymer, M.D., Savion Gropper, M.D., Ph.D., Matias Nordaby, M.D., Eva Kleine, M.Sc., Ruth Harper, Ph.D., Jenny Manassie, B.Med.Sc., James L. Januzzi, M.D., Jurrien M. ten Berg, M.D., Ph.D., P. Gabriel Steg, M.D., and Stefan H. Hohnloser, M.D., for the RE-DUAL PCI Steering Committee and Investigators*
From the Baim Institute for Clinical Research (C.P.C., J.L.J.), Brigham and Women’s Hospital, Heart and Vascular Center, and Harvard Medical School (C.P.C., D.L.B.), and the Cardiology Division, Massachusetts General Hospital, and Harvard Medical School (J.L.J.) — all in Boston; Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden (J.O.); the Institute of Cardiovascular Sciences, University of Birmingham, Birmingham (G.Y.H.L.), Boehringer Ingelheim, Bracknell (R.H., J.M.), and Imperial College, London, London (P.G.S.) — all in the United Kingdom; Cleveland Clinic, Cleveland (S.G.E.); Kyoto University, Department of Cardiovascular Medicine, Kyoto, Japan (T.K.); Aarhus University Hospital, Skejby, Denmark (M.M.); University Heart and Vascular Center, Budapest, Hungary (B.M.); Klinikum der Stadt Ludwigshafen am Rhein, Medizinische Klinik B, Ludwigshafen (U.Z.), Boehringer Ingelheim, Ingelheim (S.G., M.N., E.K.), and Johann Wolfgang Goethe University, Department of Medicine, Division of Cardiology, Frankfurt am Main (S.H.H.) — all in Germany; St. Antonius Ziekenhuis, Nieuwegein, the Netherlands (J.M.B.); and the French Alliance for Cardiovascular Trials, F-CRIN Network, DHU FIRE, Université Paris Diderot, INSERM Unité 1148, and Hôpital Bichat Assistance Publique, Paris (P.G.S.). Address reprint requests to Dr. Cannon at the Baim Institute for Clinical Research, 930 Commonwealth Ave., Boston, MA, 02215 or at christopher.cannon@baiminstitute.org. *A complete list of investigators in the Randomized Evaluation of Dual Antithrombotic Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (RE-DUAL PCI) trial is provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.

 

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