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Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2019-09-01 , DOI: 10.1056/nejmoa1908973
Stefanie Schüpke 1 , Franz-Josef Neumann 1 , Maurizio Menichelli 1 , Katharina Mayer 1 , Isabell Bernlochner 1 , Jochen Wöhrle 1 , Gert Richardt 1 , Christoph Liebetrau 1 , Bernhard Witzenbichler 1 , David Antoniucci 1 , Ibrahim Akin 1 , Lorenz Bott-Flügel 1 , Marcus Fischer 1 , Ulf Landmesser 1 , Hugo A Katus 1 , Dirk Sibbing 1 , Melchior Seyfarth 1 , Marion Janisch 1 , Duino Boncompagni 1 , Raphaela Hilz 1 , Wolfgang Rottbauer 1 , Rainer Okrojek 1 , Helge Möllmann 1 , Willibald Hochholzer 1 , Angela Migliorini 1 , Salvatore Cassese 1 , Pasquale Mollo 1 , Erion Xhepa 1 , Sebastian Kufner 1 , Axel Strehle 1 , Stefan Leggewie 1 , Abdelhakim Allali 1 , Gjin Ndrepepa 1 , Helmut Schühlen 1 , Dominick J Angiolillo 1 , Christian W Hamm 1 , Alexander Hapfelmeier 1 , Ralph Tölg 1 , Dietmar Trenk 1 , Heribert Schunkert 1 , Karl-Ludwig Laugwitz 1 , Adnan Kastrati 1 ,
Affiliation  

BACKGROUND The relative merits of ticagrelor as compared with prasugrel in patients with acute coronary syndromes for whom invasive evaluation is planned are uncertain. METHODS In this multicenter, randomized, open-label trial, we randomly assigned patients who presented with acute coronary syndromes and for whom invasive evaluation was planned to receive either ticagrelor or prasugrel. The primary end point was the composite of death, myocardial infarction, or stroke at 1 year. A major secondary end point (the safety end point) was bleeding. RESULTS A total of 4018 patients underwent randomization. A primary end-point event occurred in 184 of 2012 patients (9.3%) in the ticagrelor group and in 137 of 2006 patients (6.9%) in the prasugrel group (hazard ratio, 1.36; 95% confidence interval [CI], 1.09 to 1.70; P = 0.006). The respective incidences of the individual components of the primary end point in the ticagrelor group and the prasugrel group were as follows: death, 4.5% and 3.7%; myocardial infarction, 4.8% and 3.0%; and stroke, 1.1% and 1.0%. Definite or probable stent thrombosis occurred in 1.3% of patients assigned to ticagrelor and 1.0% of patients assigned to prasugrel, and definite stent thrombosis occurred in 1.1% and 0.6%, respectively. Major bleeding (as defined by the Bleeding Academic Research Consortium scale) was observed in 5.4% of patients in the ticagrelor group and in 4.8% of patients in the prasugrel group (hazard ratio, 1.12; 95% CI, 0.83 to 1.51; P = 0.46). CONCLUSIONS Among patients who presented with acute coronary syndromes with or without ST-segment elevation, the incidence of death, myocardial infarction, or stroke was significantly lower among those who received prasugrel than among those who received ticagrelor, and the incidence of major bleeding was not significantly different between the two groups. (Funded by the German Center for Cardiovascular Research and Deutsches Herzzentrum München; ISAR-REACT 5 ClinicalTrials.gov number, NCT01944800.).

中文翻译:

急性冠状动脉综合征患者的替格瑞洛或普拉格雷。

背景 在计划进行侵入性评估的急性冠脉综合征患者中,替格瑞洛与普拉格雷相比的相对优点尚不确定。方法在这项多中心、随机、开放标签试验中,我们将出现急性冠脉综合征并计划进行侵入性评估的患者随机分配接受替格瑞洛或普拉格雷治疗。主要终点是 1 年时死亡、心肌梗死或卒中的复合终点。一个主要的次要终点(安全终点)是出血。结果 共有 4018 名患者接受了随机分组。替格瑞洛组 2012 名患者中的 184 名 (9.3%) 和普拉格雷组 2006 名患者中的 137 名 (6.9%) 发生了主要终点事件(风险比,1.36;95% 置信区间 [CI],1.09 至1.70;P = 0.006)。替格瑞洛组和普拉格雷组主要终点各个组成部分的发生率分别为:死亡,4.5%和3.7%;心肌梗塞,分别为 4.8% 和 3.0%;和中风,1.1% 和 1.0%。替格瑞洛组和普拉格雷组中明确或可能发生支架内血栓的发生率为 1.3%,普拉格雷组为 1.0%,明确支架内血栓发生率分别为 1.1% 和 0.6%。在替格瑞洛组 5.4% 的患者和普拉格雷组 4.8% 的患者中观察到大出血(由出血学术研究协会量表定义)(风险比,1.12;95% CI,0.83 至 1.51;P = 0.46)。结论 在出现急性冠脉综合征伴或不伴 ST 段抬高的患者中,死亡、心肌梗塞、接受普拉格雷的患者中风或卒中的发生率显着低于接受替格瑞洛的患者,并且大出血的发生率在两组之间没有显着差异。(由德国心血管研究中心和 Deutsches Herzzentrum München 资助;ISAR-REACT 5 ClinicalTrials.gov 编号,NCT01944800。)。
更新日期:2019-10-17
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