Female sex was not associated with a significant difference in the 2-year composite of cardiovascular and bleeding events compared to male sex (16.1% vs 21.1%; aOR 0.42; 95% CI 0.16-1.10).
RCT (n=222)
Do clinical outcomes differ by sex in patients with recent ischemic stroke or TIA, NVAF, and concomitant ASCVD?
In patients with recent ischemic stroke, NVAF, and ASCVD, there were no significant sex differences in the 2-year composite of cardiovascular and bleeding events.
Effect estimate: aOR 0.42 (95% CI 0.16-1.10)
Absolute Event Rate: 16.1% vs 21.1%
Abstract Background and aims Nonvalvular atrial fibrillation (NVAF) and Atherosclerotic cardiovascular disease (ASCVD) often coexist, yet whether clinical outcomes differ by sex in this population remains unclear. We evaluated sex differences in a post hoc analysis of ATIS-NVAF (Optimal Antithrombotic Therapy in Ischemic Stroke patients with Nonvalvular Atrial Fibrillation and atherothrombosis), a randomized trial of patients with recent ischemic stroke or transient ischemic attack (TIA), NVAF, and concomitant ASCVD. Methods We compared baseline characteristics and clinical outcomes by sex in a post hoc analysis of ATIS-NVAF. 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 ischemic cardiovascular events; safety outcomes were major and clinically relevant non-major bleeding. We constructed a logistic regression model to estimate adjusted odds ratios (aORs) for women versus men. Results Of 222 patients, most were men (74.8%). Women were significantly older than men (median age, 79 IQR 73.3–84 vs. 77 71–81; P=0.01). Regarding atherosclerotic disease, carotid artery stenosis was significantly less common in women (5/56 (8.9%) vs. 43/166 (25.9%); P=0.008), whereas intracranial artery stenosis was more frequent (24/56 (42.9%) vs. 47/166 (28.3%); P=0.04). The primary outcome was not significantly different between women and men (16.1% vs. 21.1%; aOR, 0.42; 95% CI, 0.16–1.10). There were no statistically significant differences in secondary outcomes or in safety outcomes. Conclusions There were no significant sex differences in the 2-year composite of cardiovascular and bleeding events. Conflict of interest Dr Uchida reports lecture fees from Daiichi Sankyo, Johnson lecture fees from Abbott Medical Japan, Boston Scientific Japan, Bristol Myers Squibb, Daiichi Sankyo, Medtronic, Otsuka Pharmaceutical, and Stryker outside the submitted work. No other disclosures were reported. Funding: Bristol Myers Squibb
Uchida et al. (2026) conducted an RCT in Recent ischemic stroke or TIA, nonvalvular atrial fibrillation (NVAF), and concomitant atherosclerotic cardiovascular disease (ASCVD) (n=222). Female sex vs. Male sex was evaluated on Composite of cardiovascular death, ischemic stroke, myocardial infarction, systemic embolism, urgent revascularization for ischemia, or major bleeding within 2 years (aOR 0.42, 95% CI 0.16-1.10). Female sex was not associated with a significant difference in the 2-year composite of cardiovascular and bleeding events compared to male sex (16.1% vs 21.1%; aOR 0.42; 95% CI 0.16-1.10).