Complete Revascularization Strategies in Women and Men With Acute Coronary Syndrome and Multivessel Disease

Abstract

This prespecified substudy of the randomized BIOVASC trial aimed to compare immediate complete revascularization (ICR) and staged complete revascularization (SCR) in patients with ACS and MVD, stratified by sex. The primary endpoint consisted of a composite of all-cause mortality, myocardial infarction, unplanned ischemia driven revascularization (UIDR) and cerebrovascular events at 1 year follow-up. Secondary endpoints included the individual components of the primary composite and major bleedings. We used Cox regression models to relate randomized treatment with study endpoints. We evaluated multiplicative and additive interactions between sex and randomized treatment. The BIOVASC trial enrolled 338 women and 1187 men. Women were older than men (median 71.6 vs. 63.7 years, p<0.001) and had a higher prevalence of COPD (10.1% vs. 5.6%, p=0.003), renal insufficiency (7.7% vs. 4.4%, p=0.015) and hypertension (60.4% vs. 51.7%, p=0.005). In women, the composite primary outcome occurred in 7.3% vs. 12.9% (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.26 to 1.08) in patients randomized to ICR and SCR respectively and in men in 7.7% vs. 8.4% (HR 0.89, 95% CI 0.60 to 1.34), with no evidence of a differential effect (interaction pmultiplicative = 0.20, padditive = 0.87). No evidence of heterogeneity between women and men was found when comparing ICR with SCR in terms of the secondary outcomes. In conclusion, no differential treatment effect was found when comparing immediate complete revascularization versus staged complete revascularization in women or men presenting with ACS and MVD.