Department of Cardiology, Patras University Hospital, Patras, Greece.
Department of Cardiology, Athens General Hospital 'G. Gennimatas', Athens, Greece.
J Thromb Haemost. 2016 Jun;14(6):1146-54. doi: 10.1111/jth.13316. Epub 2016 May 4.
Essentials The comparative efficacy and safety of antiplatelet agents in 'real life' is not clear. We recruited acute coronary syndrome patients receiving percutaneous coronary intervention. At 1-year follow-up, prasugrel offers better anti-ischemic protection than clopidogrel. Prasugrel and ticagrelor are accompanied by more frequent bleeding events.
Background The comparative efficacy and safety of antiplatelet treatment outside randomized trials is not clear. Objectives To investigate long-term efficacy and safety in 'real-life' acute coronary syndrome (ACS) patients treated by percutaneous coronary intervention (PCI) with contemporary use of clopidogrel, prasugrel and ticagrelor. Methods In a prospective, observational, multicenter cohort study, 2047 patients were recruited into the GReek AntiPlatElet (GRAPE) Registry and were followed-up for 1 year for major adverse cardiovascular events (MACE, a composite of death, non-fatal myocardial infarction, urgent revascularization and stroke) and bleeding events (Bleeding Academic Research Consortium [BARC] classification). Results Exposure to clopidogrel, prasugrel and ticagrelor by PCI occurred in 959, 363 and 717 patients, respectively. After adjustment, the rate of MACE (primary outcome endpoint) was lower in prasugrel-treated patients (4.4%) than in clopidogrel-treated patients (10.1%) (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.30-0.91), although not significantly different between ticagrelor (6.8%) and clopidogrel groups (HR, 0.78; 95% CI, 0.54-1.12). Any type of BARC-classified bleeding (secondary outcome endpoint) was more frequent in prasugrel-treated patients (51.2%) than in clopidogrel-treated patients (37.6%) (HR, 1.61; 95% CI, 1.33-1.95) and more frequent in ticagrelor-treated patients (56.9%) than in clopidogrel-treated patients (HR, 1.81; 95% CI, 1.55-2.10). An adjusted comparison between prasugrel and ticagrelor-treated groups did not reveal differences in any outcome measure. After adjustment, the death rate was more reduced by novel agents in comparison with clopidogrel (2.9% vs. 6.2%). Conclusions In ACS/PCI patients, prasugrel offered better anti-ischemic protection than clopidogrel, whereas use of both novel agents is accompanied by more frequent bleeding events.
抗血小板治疗在随机试验之外的疗效和安全性尚不清楚。
研究在接受经皮冠状动脉介入治疗(PCI)的急性冠状动脉综合征(ACS)患者中,应用氯吡格雷、普拉格雷和替格瑞洛的长期疗效和安全性。
前瞻性、观察性、多中心队列研究,2047 例患者入组 GRAPE 登记研究,随访 1 年,主要不良心血管事件(MACE,死亡、非致死性心肌梗死、紧急血运重建和卒中的复合终点)和出血事件(BARC 分类)。
PCI 时应用氯吡格雷、普拉格雷和替格瑞洛的患者分别为 959、363 和 717 例。调整后,普拉格雷组(4.4%)MACE 发生率(主要终点)低于氯吡格雷组(10.1%)(风险比 [HR],0.53;95%置信区间 [CI],0.300.91),但替格瑞洛组(6.8%)与氯吡格雷组(HR,0.78;95% CI,0.541.12)无显著差异。任何类型的 BARC 分级出血(次要终点)在普拉格雷组(51.2%)较氯吡格雷组(37.6%)更常见(HR,1.61;95% CI,1.331.95),替格瑞洛组(56.9%)较氯吡格雷组(HR,1.81;95% CI,1.552.10)更常见。普拉格雷和替格瑞洛两组间的调整后比较未发现任何终点差异。与氯吡格雷相比,新型药物降低死亡率更显著(2.9% vs. 6.2%)。
在 ACS/PCI 患者中,普拉格雷较氯吡格雷有更好的抗缺血作用,而新型药物均会增加出血风险。