Outcomes by sex in the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches...

Area of Science:

• Cardiology
• Clinical Trials
• Sex-Based Medicine

Background:

• The ISCHEMIA trial demonstrated similar cardiac event risks between invasive and conservative strategies for stable coronary artery disease.
• Outcomes stratified by participant sex were not initially reported in the ISCHEMIA trial.

Purpose of the Study:

• To analyze the outcomes of the ISCHEMIA trial specifically by participant sex.
• To investigate sex-based differences in revascularization rates and primary composite outcomes.

Main Methods:

• Evaluated the association between sex and revascularization likelihood in the invasive arm.
• Assessed the primary composite outcome (cardiovascular death, MI, rehospitalization) risk by sex.
• Determined the contribution of individual outcome components to the composite outcome by sex.

Main Results:

• Women comprised 22.6% of the ISCHEMIA trial participants.
• Female sex was independently linked to a lower likelihood of revascularization in the invasive arm (aOR 0.75, p=0.04).
• The primary outcome's composite risk was similar between sexes (p-interaction=0.71), but procedural myocardial infarction (MI) was significantly lower in women (5.9%) than men (12.9%, p=0.01).

Conclusions:

• Women in the ISCHEMIA trial assigned to the invasive strategy were less likely to undergo revascularization compared to men.
• The effectiveness of invasive versus conservative strategies for coronary artery disease was consistent across sexes.
• Procedural MI contributed significantly less to the primary outcome in women compared to men.