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真实世界研究:普拉格雷与替格瑞洛用于急性心肌梗死的疗效对比:RENA MI 注册研究结果。

Real-World Data of Prasugrel vs. Ticagrelor in Acute Myocardial Infarction: Results from the RENAMI Registry.

机构信息

Department of Cardiology, Department of Medical Sciences, University of Torino, Turin, Italy.

Department of Cardiology, University Hospital Álvaro Cunqueiro, Vigo, Spain.

出版信息

Am J Cardiovasc Drugs. 2019 Aug;19(4):381-391. doi: 10.1007/s40256-019-00339-3.

Abstract

BACKGROUND

Limited data are available concerning differences in clinical outcomes for real-life patients treated with ticagrelor versus prasugrel after percutaneous coronary intervention (PCI).

OBJECTIVE

Our objective was to determine and compare the efficacy and safety of ticagrelor and prasugrel in a real-world population.

METHODS

RENAMI was a retrospective, observational registry including the data and outcomes of consecutive patients with acute coronary syndrome (ACS) who underwent primary PCI and were discharged with dual antiplatelet therapy (DAPT) between January 2012 and January 2016. The mean follow-up period was 17 ± 9 months. In total, 11 university hospitals from six European countries participated. After propensity-score matching, there were no substantial differences in the baseline clinical and interventional features. All patients were treated with acetylsalicylic acid plus prasugrel 10 mg once daily or acetylsalicylic acid plus ticagrelor 90 mg twice daily. Mean duration of DAPT was 12.04 ± 3.4 months with prasugrel and 11.90 ± 4.1 months with ticagrelor (p = 0.47). The primary and secondary endpoints were long-term net adverse clinical events (NACE) and major adverse cardiovascular events (MACE), respectively, along with their single components. Subgroup analysis for freedom from NACE and MACE was performed according to length of DAPT and clinical presentation [ST-elevation myocardial infarction (STEMI)-ACS versus non-ST-elevation myocardial infarction (NSTEMI)-ACS].

RESULTS

In total, 4424 patients (2725 ticagrelor, 1699 prasugrel) were enrolled. After propensity-score matching, 1290 patients in each cohort were included in the analysis. At 12 months, the incidence of both NACE and MACE was lower with prasugrel (NACE: 5.3% vs. 8.5% [p = 0.001]; MACE: 5% vs. 8.1% [p =  0.001]) mainly driven by a reduction in recurrent myocardial infarction (MI) (2.4 vs. 4.0%; p = 0.029) and a lower rate of Bleeding Academic Research Consortium (BARC) 3-5 bleeding (1.5 vs. 2.9%; p = 0.011). The benefit of prasugrel was confirmed for patients with NSTEMI and for those discharged with a DAPT regimen of ≤ 12 months. Only a trend in the reduction of NACE and MACE was noted for STEMI or for those treated with longer DAPT.

CONCLUSIONS

Comparison of these drugs suggested that prasugrel is safer and more efficacious than ticagrelor in combination with aspirin after NSTEMI but not STEMI. No differences were found for events occurring after 12 months. The nonrandomized design of the present research means further studies are required to support these findings.

摘要

背景

经皮冠状动脉介入治疗(PCI)后,真实世界中使用替格瑞洛和普拉格雷治疗的患者在临床结局方面存在差异,相关数据有限。

目的

本研究旨在确定并比较替格瑞洛和普拉格雷在真实世界人群中的疗效和安全性。

方法

RENA MI 是一项回顾性、观察性登记研究,纳入了 2012 年 1 月至 2016 年 1 月期间因急性冠状动脉综合征(ACS)接受直接 PCI 且出院时接受双联抗血小板治疗(DAPT)的连续患者的数据和结局。平均随访时间为 17±9 个月。共有来自欧洲六个国家的 11 所大学医院参与了此项研究。经过倾向评分匹配后,两组患者的基线临床和介入特征基本无差异。所有患者均接受阿司匹林联合普拉格雷 10mg 每日 1 次或阿司匹林联合替格瑞洛 90mg 每日 2 次治疗。普拉格雷组 DAPT 的平均持续时间为 12.04±3.4 个月,替格瑞洛组为 11.90±4.1 个月(p=0.47)。主要终点和次要终点分别为长期净不良临床事件(NACE)和主要不良心血管事件(MACE),及其单个组成部分。根据 DAPT 的持续时间和临床表现[ST 段抬高型心肌梗死(STEMI)-ACS 与非 ST 段抬高型心肌梗死(NSTEMI)-ACS]进行 NACE 和 MACE 无事件的亚组分析。

结果

共纳入 4424 例患者(替格瑞洛组 2725 例,普拉格雷组 1699 例)。经过倾向评分匹配后,每组各纳入 1290 例患者进行分析。在 12 个月时,普拉格雷组 NACE(5.3% vs. 8.5%[p=0.001])和 MACE(5% vs. 8.1%[p=0.001])的发生率均较低,主要归因于复发性心肌梗死(2.4% vs. 4.0%[p=0.029])和较高的 Bleeding Academic Research Consortium(BARC)3-5 级出血(1.5% vs. 2.9%[p=0.011])发生率较低。普拉格雷在 NSTEMI 患者和 DAPT 疗程≤12 个月的患者中更安全且更有效,这一结果得到了证实。仅在 STEMI 患者或接受较长 DAPT 治疗的患者中观察到 NACE 和 MACE 减少的趋势。

结论

这两种药物的比较表明,普拉格雷在 NSTEMI 患者中比替格瑞洛联合阿司匹林更安全、更有效,但在 STEMI 患者中无差异。在 12 个月后,未发现事件有差异。本研究的非随机设计意味着需要进一步的研究来支持这些发现。

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