普拉格雷与替格瑞洛在经皮冠状动脉介入治疗的急性心肌梗死患者中的应用：多中心随机 PRAGUE-18 研究。
Prasugrel Versus Ticagrelor in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: Multicenter Randomized PRAGUE-18 Study.
机构信息
From Cardiocenter, Third Faculty of Medicine, Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic (Z.M., J.K., P.W.); First Department of Internal Medicine-Cardioangiology, ICRC, Faculty of Medicine of Masaryk University and St. Anne's University Hospital, Brno, Czech Republic (O.H., P. Kramarikova); Department of Internal Medicine and Cardiology, Faculty of Medicine of Masaryk University and University Hospital Brno, Brno, Czech Republic (R.M., P. Kala); Department of Cardiology, University Hospital and Faculty of Medicine in Pilsen, Charles University, Prague, Czech Republic (M.H., R.R.); Cardiology Centre AGEL, Pardubice, Czech Republic (I.V.); First Department of Internal Medicine, University Hospital Hradec Kralove, Charles University in Prague, Faculty of Medicine in Hradec Kralove, Czech Republic (J.D.); Institute of Biostatistics and Analyses at the Faculty of Medicine and the Faculty of Science of the Masaryk University, Brno, Czech Republic (J..J.); Cardiocenter, Department of Cardiology, Regional Hospital, Ceske Budejovice, Czech Republic (F.T.); Cardiocenter, Regional Hospital, Karlovy Vary, Czech Republic (B.M.); Cardiocenter, Hospital Na Homolce, Prague, Czech Republic (B.M.); Second Department of Medicine-Department of Cardiovascular Medicine, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic (S.S.); AGEL Research and Training Institute, Trinec Branch, Cardiovascular Center, Podlesi Hospital, Trinec, Czech Republic (M.B.); Cardiovascular Department, University Hospital Ostrava, Ostrava, Czech Republic (J.M.); Department of Cardiology, Krajska zdravotni a.s., Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic (P.C.); and First Internal Cardiology Clinic, University Hospital Olomouc, Olomouc, Czech Republic (J.O.).
出版信息
Circulation. 2016 Nov 22;134(21):1603-1612. doi: 10.1161/CIRCULATIONAHA.116.024823. Epub 2016 Aug 30.
BACKGROUND
No randomized head-to-head comparison of the efficacy and safety of ticagrelor and prasugrel has been published in the 7 years since the higher efficacy of these newer P2Y inhibitors were first demonstrated relative to clopidogrel.
METHODS
This academic study was designed to compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction treated with primary or immediate percutaneous coronary intervention. A total of 1230 patients were randomly assigned across 14 sites to either prasugrel or ticagrelor, which was initiated before percutaneous coronary intervention. Nearly 4% were in cardiogenic shock, and 5.2% were on mechanical ventilation. The primary end point was defined as death, reinfarction, urgent target vessel revascularization, stroke, or serious bleeding requiring transfusion or prolonging hospitalization at 7 days (to reflect primarily the in-hospital phase). This analysis presents data from the first 30 days (key secondary end point). The total follow-up will be 1 year for all patients and will be completed in 2017.
RESULTS
The study was prematurely terminated for futility. The occurrence of the primary end point did not differ between groups receiving prasugrel and ticagrelor (4.0% and 4.1%, respectively; odds ratio, 0.98; 95% confidence interval, 0.55-1.73; P=0.939). No significant difference was found in any of the components of the primary end point. The occurrence of key secondary end point within 30 days, composed of cardiovascular death, nonfatal myocardial infarction, or stroke, did not show any significant difference between prasugrel and ticagrelor (2.7% and 2.5%, respectively; odds ratio, 1.06; 95% confidence interval, 0.53-2.15; P=0.864).
CONCLUSIONS
This head-to-head comparison of prasugrel and ticagrelor does not support the hypothesis that one is more effective or safer than the other in preventing ischemic and bleeding events in the acute phase of myocardial infarction treated with a primary percutaneous coronary intervention strategy. The observed rates of major outcomes were similar but with broad confidence intervals around the estimates. These interesting observations need to be confirmed in a larger trial.
CLINICAL TRIAL REGISTRATION
URL: http://www.ClinicalTrials.gov. Unique identifier: NCT02808767.
背景
自新型 P2Y12 抑制剂比氯吡格雷更有效这一发现公布以来的 7 年里，尚未有 ticagrelor 和 prasugrel 的疗效和安全性的随机头对头比较发表。
方法
本学术研究旨在比较急性心肌梗死患者接受直接或即刻经皮冠状动脉介入治疗时，普拉格雷和替格瑞洛的疗效和安全性。共有 1230 名患者在 14 个地点随机分为普拉格雷或替格瑞洛组，在经皮冠状动脉介入治疗前开始用药。近 4%的患者发生心原性休克，5.2%的患者需要机械通气。主要终点定义为死亡、再梗死、紧急靶血管血运重建、卒中和需要输血或延长住院时间的严重出血（主要反映住院期）。该分析报告了前 30 天（关键次要终点）的数据。所有患者的总随访时间为 1 年，将于 2017 年完成。
结果
研究因无效而提前终止。接受普拉格雷和替格瑞洛的患者主要终点的发生率无差异（分别为 4.0%和 4.1%；比值比，0.98；95%置信区间，0.55-1.73；P=0.939）。主要终点的任何组成部分均未发现显著差异。30 天内关键次要终点（心血管死亡、非致命性心肌梗死或卒中等）的发生率在普拉格雷和替格瑞洛之间也无显著差异（分别为 2.7%和 2.5%；比值比，1.06；95%置信区间，0.53-2.15；P=0.864）。
结论
本研究未支持普拉格雷和替格瑞洛在预防经皮冠状动脉介入治疗策略治疗的急性心肌梗死的缺血和出血事件方面，一种药物比另一种更有效或更安全的假设。主要结局的观察发生率相似，但估计值的置信区间较宽。这些有趣的观察结果需要在更大的试验中得到证实。
Zotero 插件