A large pooled analysis found no evidence that men and women with coronary artery disease respond differently to more intensive versus less intensive antithrombotic therapy.
The analysis included 33 randomized controlled trials with 274,433 patients enrolled between 1999 and 2025. Women accounted for about 25% of participants. All had established coronary artery disease and were treated with antiplatelet agents, anticoagulants, or combinations of these drugs. Regimens were classified as “more intensive” or “less intensive” based on medication type, potency, dosage, or duration.
Across the pooled data, more intensive therapy reduced myocardial infarction risk by about 15% in both sexes. Stent thrombosis risk was reduced by approximately 30% for men and women alike. These benefits were accompanied by more than a 40% higher risk of major bleeding in both groups compared with less intensive regimens.
No sex-related differences were found in all-cause mortality, cardiovascular mortality, stroke, or the composite of death, myocardial infarction, or stroke. A modest mortality reduction was observed in men but not in women, though this difference was not statistically significant.
“A patient’s sex should not guide selection of antithrombotic therapies in people with established coronary artery disease,” noted Raffaele Piccolo, MD, Department of Advanced Biomedical Sciences, University of Naples Federico II, and colleagues.
Results were consistent across various therapy comparisons, including high-versus low-potency antiplatelet regimens, anticoagulant versus placebo, and longer versus shorter dual antiplatelet therapy. Sensitivity analyses limited to currently recommended regimens or stratified by follow-up duration produced similar results.
Women remain underrepresented in cardiovascular research, comprising only one-quarter of participants in the included trials. More than half of otherwise eligible studies were excluded because they did not report sex-specific results.
However, the study used trial-level rather than individual patient-level data, limiting the ability to examine more detailed interactions between sex and treatment effect. The included trials varied in patient characteristics, clinical presentations, treatment regimens, and endpoint definitions. Classifying therapies as “more intensive” or “less intensive” encompassed diverse drugs and combinations, which could mask differences within specific drug classes.
No randomized trial has been conducted exclusively in women with coronary artery disease, leaving gaps in knowledge about potential differences in certain subgroups. The lack of sex-disaggregated reporting in many cardiovascular trials further restricts the ability to make fully informed sex-specific treatment decisions.
Disclosures can be found in the published study.
Source: The BMJ