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替格瑞洛或普拉格雷治疗急性冠状动脉综合征患者
Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes


Stefanie Schüpke ... 心脑血管疾病 • 2019.10.17
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ISAR-REACT 5:结果出人意料,ACS中普拉格雷优于替格瑞洛

 

席子惟,刘巍*

首都医科大学附属北京安贞医院心内科

*通讯作者

 

据统计,2019年美国将会有720,000名新发的急性冠状动脉综合征(ACS)患者,以及335,000名再发ACS的患者,疾病负担较重,双联抗血小板治疗是这类患者的基础治疗之一。目前已有可靠的随机对照研究证实,在ACS患者中,强效的抗血小板药物替格瑞洛、普拉格雷优于传统的氯吡格雷,这两种药物在目前的临床指南中均为Ⅰ类推荐。

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摘要


背景

在计划接受有创检查的急性冠状动脉综合征患者中,替格瑞洛和普拉格雷的相对优势尚未明确。

 

方法

在这项多中心、随机、开放标签试验中,我们将因急性冠状动脉综合征就诊,并且计划接受有创检查的患者随机分组,分别接受替格瑞洛或普拉格雷治疗。主要终点是由1年时的死亡、心肌梗死或卒中构成的复合终点。一项关键次要终点(安全性终点)是出血。

 

结果

共有4,018例患者接受了随机分组。替格瑞洛组2,012例患者中的184例(9.3%)和普拉格雷组2,006例患者中的137例(6.9%)发生了主要终点事件(风险比,1.36;95% CI,1.09~1.70;P=0.006)。在替格瑞洛组和普拉格雷组中,主要终点各构成部分的发生率如下:死亡,4.5%和3.7%;心肌梗死,4.8%和3.0%;卒中,1.1%和1.0%。替格瑞洛组1.3%的患者和普拉格雷组1.0%的患者明确或很可能发生了支架内血栓形成,明确支架内血栓形成的发生率分别为1.1%和0.6%。替格瑞洛组和普拉格雷组的大出血(根据出血学术研究联合会[Bleeding Academic Research Consortium]量表的定义)发生率分别为5.4%和4.8%(风险比,1.12;95% CI,0.83~1.51;P=0.46)。

 

结论

在因冠状动脉综合征(伴或不伴ST段抬高)就诊的患者中,普拉格雷组患者的死亡、心肌梗死或卒中发生率显著低于替格瑞洛组,两组的大出血发生率无显著差异(由德国心血管研究中心[German Center for Cardiovascular Research]和德国慕尼黑心脏中心[Deutsches Herzzentrum München]资助;ISAR-REACT 5在ClinicalTrials.gov注册号为NCT01944800)。





作者信息

Stefanie Schüpke, M.D., Franz-Josef Neumann, M.D., Maurizio Menichelli, M.D., Katharina Mayer, M.D., Isabell Bernlochner, M.D., Jochen Wöhrle, M.D., Gert Richardt, M.D., Christoph Liebetrau, M.D., Bernhard Witzenbichler, M.D., David Antoniucci, M.D., Ibrahim Akin, M.D., Lorenz Bott-Flügel, M.D., Marcus Fischer, M.D., Ulf Landmesser, M.D., Hugo A. Katus, M.D., Dirk Sibbing, M.D., Melchior Seyfarth, M.D., Marion Janisch, M.D., Duino Boncompagni, M.D., Raphaela Hilz, M.D., Wolfgang Rottbauer, M.D., Rainer Okrojek, M.D., Helge Möllmann, M.D., Willibald Hochholzer, M.D., Angela Migliorini, M.D., Salvatore Cassese, M.D., Pasquale Mollo, M.D., Erion Xhepa, M.D., Sebastian Kufner, M.D., Axel Strehle, M.D., Stefan Leggewie, M.D., Abdelhakim Allali, M.D., Gjin Ndrepepa, M.D., Helmut Schühlen, M.D., Dominick J. Angiolillo, M.D., Ph.D., Christian W. Hamm, M.D., Alexander Hapfelmeier, M.Sc., Ralph Tölg, M.D., Dietmar Trenk, M.D., Ph.D., Heribert Schunkert, M.D., Karl-Ludwig Laugwitz, M.D., and Adnan Kastrati, M.D. for the ISAR-REACT 5 Trial Investigators*
From the Department of Cardiology, Deutsches Herzzentrum München, and Technische Universität München (S.S., K.M., M.J., R.H., S.C., E.X., S.K., G.N., H. Schunkert, A.K.), the German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance (S.S., D.S., H. Schunkert, K.-L.L., A.K.), the Department of Cardiology, Angiology, and Pulmonology, Medizinische Klinik und Poliklinik I, Klinikum rechts der Isar (I.B., R.O., K.-L.L.), the Department of Cardiology, Klinikum der Universität München, Ludwig–Maximilians–University (D.S.), and the Institute of Medical Informatics, Statistics, and Epidemiology, School of Medicine, Technische Universität München (A.H.), Munich, the Department of Cardiology and Angiology II, University Heart Center Freiburg–Bad Krozingen, Bad Krozingen (F.-J.N., W.H., S.L., D.T.), the Department of Cardiology, Ulm University Hospital, Ulm (J.W., W.R.), the Heart Center Bad Segeberg, Bad Segeberg (G.R., A.A., R.T.), the Heart Center, Kerckhoff Campus of Justus–Liebig University, Giessen (C.L., H.M., C.W.H.), DZHK, Partner Site Rhine-Main, Bad Nauheim (C.W.H.), the Department of Cardiology and Pneumology, Helios Amper-Klinikum Dachau, Dachau (B.W., A.S.), the Department of Cardiology, University Clinic Mannheim (I.A.), and DZHK, Partner Site Heidelberg–Mannheim (I.A., H.A.K.), Mannheim, the Department of Cardiology, Klinikum Landkreis Erding, Erding (L.B.-F.), the Department of Internal Medicine II, University Medical Center Regensburg, Regensburg (M.F.), the Department of Cardiology, Charité–University Medicine Berlin (U.L.), Berlin Institute of Health (U.L.), DZHK, Partner Site Berlin (U.L.), and Vivantes Auguste–Viktoria–Klinikum (H. Schühlen), Berlin, the Department of Cardiology, University Clinic Heidelberg (H.A.K.), and DZHK, Partner Site Heidelberg–Mannheim (I.A., H.A.K.), Heidelberg, the Department of Cardiology, Helios University Hospital and University of Witten–Herdecke, Wuppertal (M.S.) — all in Germany; the Department of Cardiology, Ospedale Fabrizio Spaziani, Frosinone (M.M., D.B., P.M.), and Careggi University Hospital, Florence (D.A., A.M.) — both in Italy; and the Division of Cardiology, University of Florida College of Medicine, Jacksonville (D.J.A.). Address reprint requests to Dr. Schüpke at Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany, or at schuepke@dhm.mhn.de. *A list of the centers and investigators participating in the ISAR-REACT 5 trial is provided in the Supplementary Appendix, available at NEJM.org.

 

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