替格瑞洛或普拉格雷在急性冠状动脉综合征患者中的应用。
Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes.
机构信息
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.).
出版信息
N Engl J Med. 2019 Oct 17;381(16):1524-1534. doi: 10.1056/NEJMoa1908973. Epub 2019 Sep 1.
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.).
背景
对于计划进行有创评估的急性冠脉综合征患者，替格瑞洛与普拉格雷相比孰优孰劣尚不确定。
方法
在这项多中心、随机、开放标签试验中，我们将表现为急性冠脉综合征且计划进行有创评估的患者随机分配，分别接受替格瑞洛或普拉格雷治疗。主要终点是 1 年时的死亡、心肌梗死或卒中等复合终点。主要次要终点（安全性终点）为出血。
结果
共有 4018 例患者进行了随机分组。替格瑞洛组 2012 例患者中有 184 例（9.3%）和普拉格雷组 2006 例患者中有 137 例（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的主要终点各组成部分的发生率分别为：死亡 4.5% 和 3.7%；心肌梗死 4.8% 和 3.0%；卒 1.1% 和 1.0%。替格瑞洛组和普拉格雷组分别有 1.3%和 1.0%的患者发生确定或可能的支架血栓形成，其中确定支架血栓形成分别为 1.1%和 0.6%。根据出血学术研究联合会（Bleeding Academic Research Consortium）量表定义，替格瑞洛组有 5.4%的患者发生主要出血，普拉格雷组有 4.8%的患者发生主要出血（风险比，1.12；95%CI，0.83 至 1.51；P=0.46）。
结论
在伴有或不伴有 ST 段抬高的急性冠脉综合征患者中，与接受替格瑞洛治疗的患者相比，接受普拉格雷治疗的患者的死亡、心肌梗死或卒中等复合终点发生率显著降低，而两组之间的大出血发生率无显著差异。（由德国心血管研究中心和慕尼黑心脏中心资助；ISAR-REACT 5 ClinicalTrials.gov 编号，NCT01944800。）
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