在这项多中心、随机、开放标签的试验中，研究人员招募了急性冠脉综合征且计划有创评估的患者4018例，随机分配接受替卡格雷（2012名）或普拉格雷（2006名）治疗。主要终点是1年内死亡、心肌梗死或中风的综合。
替卡格雷组中有184名患者（9.3%）发生主要终点，普拉格雷组中有137名（6.9%），风险比为1.36。替卡格雷组和普拉格雷组主要终点的个体发生率分别为：死亡4.5%和3.7%，心肌梗死4.8%和3.0%，中风1.1%和1.0%。替卡格雷组1.3%和普拉格雷组1.0%的患者发生明确或很可能的支架血栓，其中明确的支架血栓发生率分别为1.1%和0.6%。替卡格雷组5.4%和普拉格雷组4.8%的患者出现大出血，风险比为1.12。
研究结果发现，对于伴或不伴ST段抬高的急性冠脉综合征患者，与替卡格雷相比，普拉格雷可显著降低患者的死亡、心肌梗死或中风发生率，且大出血发生率未显著增加。
据悉，替卡格雷与普拉格雷在计划有创评估的急性冠状动脉综合征患者中的相对优势尚不确定。
附：英文原文
Title: Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes
Author: 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*
Issue&Volume: September 1, 2019
Abstract：
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.)
The New England Journal of Medicine：《新英格兰医学杂志》，创刊于1812年。隶属于麻省医学协会，最新IF：70.67
官方网址：http://www.nejm.org/
投稿链接：http://www.nejm.org/page/author-center/home