Deutsches Herzzentrum München, Cardiology and Technische Universität München, Munich, Germany (A.A., G.N., K.M., S.L., S.C., S.K., E.X., H.B.S., M.J., M.F., H.S., S.S., A.K).
Department of Cardiology and Angiology II, University Heart Center Freiburg·Bad Krozingen, Germany (F.J.N., C.V., D.T.).
Circulation. 2020 Dec 15;142(24):2329-2337. doi: 10.1161/CIRCULATIONAHA.120.050244. Epub 2020 Oct 29.
Data on the comparative efficacy and safety of ticagrelor versus prasugrel in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention are limited. We assessed the efficacy and safety of ticagrelor versus prasugrel in a head-to-head comparison in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.
In this prespecified subgroup analysis, we included 1653 patients with ST-segment-elevation myocardial infarction randomized to receive ticagrelor or prasugrel in the setting of the ISAR REACT-5 trial (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment 5). The primary end point was the incidence of death, myocardial infarction, or stroke at 1 year after randomization. The secondary end point was the incidence of bleeding defined as BARC (Bleeding Academic Research Consortium) type 3 to 5 bleeding at 1 year after randomization.
The primary end point occurred in 83 patients (10.1%) in the ticagrelor group and in 64 patients (7.9%) in the prasugrel group (hazard ratio, 1.31 [95% CI, 0.95-1.82]; =0.10). One-year incidence of all-cause death (4.9% versus 4.7%; =0.83), stroke (1.3% versus 1.0%; =0.46), and definite stent thrombosis (1.8% versus 1.0%; =0.15) did not differ significantly in patients assigned to ticagrelor or prasugrel. One-year incidence of myocardial infarction (5.3% versus 2.8%; hazard ratio, 1.95 [95% CI, 1.18-3.23]; =0.010) was higher with ticagrelor than with prasugrel. BARC type 3 to 5 bleeding occurred in 46 patients (6.1%) in the ticagrelor group and in 39 patients (5.1%) in the prasugrel group (hazard ratio, 1.22 [95% CI, 0.80-1.87]; =0.36).
In patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention, there was no significant difference in the primary end point between prasugrel and ticagrelor. Ticagrelor was associated with a significant increase in the risk for recurrent myocardial infarction. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01944800.
关于替格瑞洛与普拉格雷在接受直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中的疗效和安全性比较的数据有限。我们评估了替格瑞洛与普拉格雷在直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中头对头比较的疗效和安全性。
在这项预先设定的亚组分析中,我们纳入了 ISAR REACT-5 试验(冠状动脉内支架置入和抗血栓治疗方案:快速冠状动脉治疗 5 期)中随机接受替格瑞洛或普拉格雷治疗的 1653 例 ST 段抬高型心肌梗死患者。主要终点为随机分组后 1 年时的死亡、心肌梗死或卒中发生率。次要终点为随机分组后 1 年时定义为 BARC(出血学术研究联合会)3 至 5 级出血的出血发生率。
替格瑞洛组 83 例(10.1%)和普拉格雷组 64 例(7.9%)患者发生主要终点事件(风险比,1.31 [95%CI,0.95-1.82];=0.10)。替格瑞洛组和普拉格雷组患者的全因死亡率(4.9%与 4.7%;=0.83)、卒中发生率(1.3%与 1.0%;=0.46)和明确支架血栓形成发生率(1.8%与 1.0%;=0.15)差异均无统计学意义。替格瑞洛组 1 年时心肌梗死发生率(5.3%与 2.8%;风险比,1.95 [95%CI,1.18-3.23];=0.010)高于普拉格雷组。替格瑞洛组 46 例(6.1%)和普拉格雷组 39 例(5.1%)患者发生 BARC 3 至 5 级出血(风险比,1.22 [95%CI,0.80-1.87];=0.36)。
在接受直接经皮冠状动脉介入治疗的 ST 段抬高型心肌梗死患者中,普拉格雷与替格瑞洛之间主要终点无显著差异。替格瑞洛与心肌梗死再发风险增加相关。