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急性冠状动脉综合征患者非就诊时段与就诊时段应用替格瑞洛或普拉格雷的疗效比较:ISAR-REACT 5 试验亚组分析。

Ticagrelor or prasugrel in patients with acute coronary syndrome with off-hour versus on-hour presentation: a subgroup analysis of the ISAR-REACT 5 trial.

机构信息

First Department of Medicine, Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.

Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

出版信息

Clin Res Cardiol. 2023 Apr;112(4):518-528. doi: 10.1007/s00392-022-02040-z. Epub 2022 Jul 5.

Abstract

OBJECTIVES

To assess the efficacy and safety of ticagrelor versus prasugrel in patients with acute coronary syndrome (ACS) presenting during off- and on-hours.

BACKGROUND

The efficacy and safety of ticagrelor versus prasugrel in patients with ACS according to time of hospital presentation remain unknown.

METHODS

This post hoc analysis of the ISAR-REACT 5 trial included 1565 patients with ACS presenting off-hours and 2453 patients presenting on-hours, randomized to ticagrelor or prasugrel. The primary endpoint was a composite of death, myocardial infarction, or stroke; the safety endpoint was Bleeding Academic Research Consortium (BARC) type 3-5 bleeding, both at 12 months.

RESULTS

The primary endpoint occurred in 80 patients (10.4%) in the ticagrelor group and 57 patients (7.3%) in the prasugrel group in patients presenting off-hours (hazard ratio [HR] = 1.45; 95% confidence interval [CI] 1.03-2.03; P = 0.033), and 104 patients (8.5%) in the ticagrelor group and 80 patients (6.7%) in the prasugrel group in patients presenting on-hours (HR = 1.29 [0.97-1.73]; P = 0.085), without significant treatment arm-by-presentation time interaction (P = 0.62). BARC type 3 to 5 bleeding occurred in 35 patients (5.1%) in the ticagrelor group and 37 patients (5.3%) in the prasugrel group (P = 0.84) in patients presenting off-hours, and 60 patients (5.9%) in the ticagrelor group and 43 patients (4.6%) in the prasugrel group in patients presenting on-hours (P = 0.17).

CONCLUSIONS

In patients with ACS planned to undergo an invasive treatment strategy, time of presentation (off-hours vs. on-hours) does not interact significantly with the relative efficacy and safety of ticagrelor vs. prasugrel.

CLINICAL TRIAL REGISTRATION

NCT01944800.

摘要

目的

评估替格瑞洛与普拉格雷在非就诊时间和就诊时间的急性冠脉综合征(ACS)患者中的疗效和安全性。

背景

ACS 患者根据就诊时间接受替格瑞洛与普拉格雷治疗的疗效和安全性尚不清楚。

方法

本 ISAR-REACT 5 试验的事后分析纳入了 1565 例非就诊时间就诊的 ACS 患者和 2453 例就诊时间就诊的 ACS 患者,随机分配至替格瑞洛组或普拉格雷组。主要终点为死亡、心肌梗死或卒中等复合终点;安全性终点为 12 个月时的出血学术研究联合会(BARC)3-5 级出血。

结果

非就诊时间就诊的患者中,替格瑞洛组有 80 例(10.4%)患者发生主要终点事件,普拉格雷组有 57 例(7.3%)患者发生(风险比 [HR] = 1.45;95%置信区间 [CI] 1.03-2.03;P = 0.033),就诊时间就诊的患者中,替格瑞洛组有 104 例(8.5%)患者发生主要终点事件,普拉格雷组有 80 例(6.7%)患者发生(HR = 1.29 [0.97-1.73];P = 0.085),无明显的治疗分组-就诊时间交互作用(P = 0.62)。非就诊时间就诊的患者中,替格瑞洛组有 35 例(5.1%)患者发生 BARC 3-5 级出血,普拉格雷组有 37 例(5.3%)患者发生(P = 0.84),就诊时间就诊的患者中,替格瑞洛组有 60 例(5.9%)患者发生 BARC 3-5 级出血,普拉格雷组有 43 例(4.6%)患者发生(P = 0.17)。

结论

在计划接受有创治疗策略的 ACS 患者中,就诊时间(非就诊时间 vs. 就诊时间)与替格瑞洛与普拉格雷的相对疗效和安全性无显著交互作用。

临床试验注册

NCT01944800。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/39a0/10050020/11ee65585851/392_2022_2040_Fig1_HTML.jpg

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