Sex differences in the incidence of composite ischemic and bleeding events in ischemic stroke patients with nonvalvular atrial fibrillation and atherosclerosis

BACKGROUND: Nonvalvular atrial fibrillation (NVAF) and atherosclerotic cardiovascular disease (ASCVD) frequently coexist, but whether clinical outcomes differ by sex in this population remains unclear. We evaluated sex differences in a post hoc analysis of the Optimal Antithrombotic Therapy in Ischemic Stroke Patients with Nonvalvular Atrial Fibrillation and Atherothrombosis (ATIS-NVAF) trial, a randomized study of patients with recent ischemic stroke or transient ischemic attack (TIA), NVAF, and concomitant ASCVD. METHODS: Baseline patient characteristics and clinical outcomes were compared by sex. The primary outcome was the composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, urgent revascularization for ischemia, or major bleeding within 2 years. Secondary outcomes were all ischemic cardiovascular events, ischemic stroke, all-cause mortality and myocardial infarction or cardiovascular death. The safety outcomes were major bleeding, clinically relevant non-major bleeding and intracranial hemorrhage. Multivariable logistic regression models were used to estimate adjusted odds ratios (aORs) for women versus men. RESULTS: Of the 222 patients, most were men (74.8%). The primary outcome did not differ significantly between women and men (16.1% vs. 21.1%; aOR, 0.60; 95% confidence interval, 0.25-1.46). No significant differences were observed in secondary or safety outcomes. CONCLUSIONS: In this post hoc analysis of the ATIS-NVAF trial, no significant sex differences were observed in the 2-year composite of cardiovascular and bleeding events among patients with recent ischemic stroke or TIA and concomitant NVAF and ASCVD. Appropriate medical management may attenuate the influence of biological sex on the risk of cardiovascular and bleeding events.