Sex related differences in efficacy and safety of antithrombotic therapy in patients with coronary artery disease: systematic review and meta-analysis.

Methods

Systematic reviewand meta-analysis.

系统评价和荟萃分析。

data_sources

Ovid Medline and Embase databases from inception to April 2025.

检索了自建库至2025年4月的Ovid Medline和Embase数据库。

inclusion_criteria

Included studies were randomised controlled trials reporting sex stratified outcomes, including ischaemic and major bleeding events, and comparing any experimental versus control antithrombotic strategy in coronary artery disease.

纳入的研究是报告性别分层结果的随机对照试验，包括缺血和主要出血事件，并比较任何实验性与对照抗血栓策略在冠状动脉疾病中的效果。

data_extraction_and_synthesis

Two reviewers extracted data and assessed the risk of bias.

两位审查员提取数据并评估了偏倚风险。

To avoid ecological bias, a within trial framework was developed to evaluate sex related heterogeneity in the treatment effect of antithrombotic therapies.

为了避免生态偏倚，开发了一种试验内框架来评估抗血栓治疗效果中性别相关的异质性。

Sex specific risk estimates were reported as hazard ratios with 95% confidence intervals, whereas trial level ratios of hazard ratios were pooled with an inverse variance model.

性别特异性的风险估计报告为带有95%置信区间的危险比，而试验水平的危险比比率则使用逆方差模型进行汇总。

Results

A total of 33 trials enrolling 274 433 participants, of which 72 601 (median proportion 25%) were women, were included.

共有33项试验纳入了274,433名参与者，其中72,601名（中位比例25%）为女性。

Patients were enrolled between 1999 and 2025.

患者招募时间为1999年至2025年。

A total of 6018 deaths occurred in 187 580 patients across 22 trials (3064 deaths in patients using more intensive antithrombotic therapies and 2954 in those using less intensive therapies).

在22项试验中，共有187,580名患者发生了6018例死亡（使用更积极抗血栓治疗的患者中有3064例死亡，而使用较不积极治疗的患者中有2954例死亡）。

The relative risk of all cause death was comparable for more intensive versus less intensive antithrombotic therapies in both women and men, without sex based interaction (interaction hazard ratio1.06, 95% confidence interval0.94 to 1.19; P for interaction=0.33; I2=0.00%; P for heterogeneity=0.76). 7558 myocardial infarctions occurred among 172 504 patients.

在女性和男性中，更密集与较不密集的抗血栓治疗相比，全因死亡的相对风险相当，没有性别交互作用（交互风险比1.06，95%置信区间0.94至1.19；交互作用P值=0.33；I2=0.00%；异质性P值=0.76）。在172,504名患者中发生了7,558例心肌梗死。

More intensive antithrombotic therapies were associated with a reduced risk of myocardial infarction by ~15% in both men and women (interaction hazard ratio1.05, 0.95 to 1.17; P for interaction=0.36; I2=14.05%; P for heterogeneity=0.28).

更密集的抗血栓治疗与男性和女性心肌梗死风险降低约15%相关（交互风险比1.05，95%置信区间0.95至1.17；交互作用P值=0.36；I2=14.05%；异质性P值=0.28）。

Conversely, major bleeding was significantly increased by ~40% for more intensive versus less intensive antithrombotic therapies irrespective of sex (interaction hazard ratio0.99, 0.86 to 1.15; P for interaction=0.93; I2=33.56%; P for heterogeneity=0.05).

相反地，无论性别如何，与较不密集的抗血栓治疗相比，更密集的抗血栓治疗显著增加了约40%的主要出血风险（交互风险比0.99，95%置信区间0.86至1.15；交互作用P值=0.93；I2=33.56%；异质性P值=0.05）。

Overall, 4003 major bleeding events occurred (2384 in patients using more intensive therapies and 1619 in those using less intensive therapies).

总体而言，发生了4003起主要出血事件（2384起发生在使用更密集治疗的患者中，1619起发生在使用较不密集治疗的患者中）。

Conclusions

Antithrombotic therapies in patients with established coronary artery disease provided consistent efficacy and safety outcomes in women and men.

在已确诊冠状动脉疾病患者中，抗血栓治疗在女性和男性中提供了持续的疗效和安全性结果。

systematic_review_registration

PROSPERO CRD42024560908.

PROSPERO CRD42024560908。