替格瑞洛与普拉格雷在急性冠状动脉综合征女性和男性患者中的疗效和安全性：ISAR-REACT 5 试验的预先设定的、基于性别的分析。

Efficacy and Safety of Ticagrelor Versus Prasugrel in Women and Men with Acute Coronary Syndrome: A Pre-specified, Sex-Specific Analysis of the ISAR-REACT 5 Trial.

机构信息

Deutsches Herzzentrum München, Cardiology, and Technische Universität München.

German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance.

出版信息

J Atheroscler Thromb. 2022 May 1;29(5):747-761. doi: 10.5551/jat.62776. Epub 2021 Apr 16.

AIM

Sex-specific analyses of direct head-to-head comparisons between newer P2Y inhibitors are limited. This study was conducted to assess the efficacy and safety of ticagrelor versus prasugrel in women and men with acute coronary syndromes (ACS) planned for an invasive strategy.

METHODS

This pre-specified analysis of the ISAR-REACT 5 trial included 956 women and 3,062 men with ACS randomly assigned to either ticagrelor or prasugrel. The primary endpoint was the 12-month incidence of death, myocardial infarction, or stroke; the safety endpoint was the 12-month incidence of bleeding (type 3-5 according to the Bleeding Academic Research Consortium [BARC]).

RESULTS

The primary endpoint occurred in 42 women (8.9%) in the ticagrelor group and 39 women (8.3%) in the prasugrel group (hazard ratio [HR]=1.10, 95% confidence interval [CI] 0.71-1.70, P=0.657) and in 142 men (9.4%) in the ticagrelor group and 98 men (6.5%) in the prasugrel group (HR=1.47 [1.13-1.90], P=0.004; P for interaction [P]=0.275). BARC type 3-5 bleeding occurred in 36 women (9.7%) in the ticagrelor group and 34 women (9.7%) in the prasugrel group (HR=1.04 [0.65-1.67], P=0.856) and in 59 men in the ticagrelor group (4.4%) and 46 men (3.6%) in the prasugrel group (HR=1.24 [0.85-1.83], P=0.266; P=0.571).

CONCLUSIONS

Although there was no significant interaction between sex and treatment effect of study drugs, the superior efficacy of prasugrel was more evident among men. No difference in bleeding between the two study groups was seen for both women and men.

目的

针对新型 P2Y 抑制剂的直接头对头比较，其性别特异性分析有限。本研究旨在评估替格瑞洛与普拉格雷在计划采用介入策略的急性冠状动脉综合征（ACS）女性和男性患者中的疗效和安全性。

方法

本研究是 ISAR-REACT 5 试验的一项预设分析，共纳入 956 名女性和 3062 名男性 ACS 患者，随机分配至替格瑞洛或普拉格雷组。主要终点为 12 个月时的死亡、心肌梗死或卒中性事件发生率；安全性终点为 12 个月时的出血发生率（根据 Bleeding Academic Research Consortium [BARC] 标准为 3-5 型）。

结果

替格瑞洛组有 42 名女性（8.9%）和 39 名女性（8.3%）发生主要终点事件，普拉格雷组分别有 42 名女性（8.9%）和 39 名女性（8.3%）发生主要终点事件（风险比 [HR]=1.10，95%置信区间 [CI] 0.71-1.70，P=0.657）；替格瑞洛组有 142 名男性（9.4%）和 98 名男性（6.5%）发生主要终点事件，普拉格雷组分别有 142 名男性（9.4%）和 98 名男性（6.5%）发生主要终点事件（HR=1.47 [1.13-1.90]，P=0.004；P 交互检验 [P]=0.275）。替格瑞洛组有 36 名女性（9.7%）和 34 名女性（9.7%）发生 BARC 3-5 型出血，普拉格雷组分别有 36 名女性（9.7%）和 34 名女性（9.7%）发生 BARC 3-5 型出血（HR=1.04 [0.65-1.67]，P=0.856）；替格瑞洛组有 59 名男性（4.4%）和 46 名男性（3.6%）发生 BARC 3-5 型出血，普拉格雷组分别有 59 名男性（4.4%）和 46 名男性（3.6%）发生 BARC 3-5 型出血（HR=1.24 [0.85-1.83]，P=0.266；P=0.571）。