Key result
Female sex shows no difference in 2-year major CV and bleeding events versus male sex.
Why the study?
NVAF and ASCVD often coexist, but whether clinical outcomes differ by sex in this population remains unclear.
Do clinical outcomes differ by sex in patients with recent ischemic stroke or TIA, NVAF, and concomitant ASCVD?
RCT (n=222)
Do clinical outcomes differ by sex in patients with recent ischemic stroke or TIA, NVAF, and concomitant ASCVD?
Effect estimate: aOR 0.42 (95% CI 0.16-1.10)
Absolute Event Rate: 16.1% vs 21.1%
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.
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 & Johnson, Kaneka, Medtronic, Stryker, and Tokai Medical Products outside the submitted work. Dr. Yoshimura reports grants from Medico’s Hirata, Medtronic, and Terumo and lecture fees from Medtronic, Kaneka, Stryker, Daiichi Sankyo, Bristol-Meyers Squibb, and Johnson & Johnson outside the submitted work. Dr Koga reports lecture fees from Bayer Yakuhin, Boehringer Ingelheim, and Daiichi Sankyo and research funding from Boehringer Ingelheim and Daiichi Sankyo outside the submitted work. Dr Ihara reports lecturer fees from Daiichi Sankyo and Eisai and grant support from Panasonic, GE Precision Healthcare LLC, Bristol-Myers Squibb, and Shimadzu Corporation. Dr Yoshimoto reports personal fees from Eli Lilly, Daiichi Sankyo, Medico’s Hirata, Nippon Boehringer Ingelheim, Stryker, Takeda Pharmaceutical, and Tonbridge Medical. Dr Hirano reports lecture fees from Daiichi Sankyo and honoraria from Bayer Yakuhin outside the submitted work. Dr Toyoda reports personal fees from Janssen Pharmaceuticals, Otsuka Pharmaceutical, and SoftBank group outside the submitted work. Dr Sakai reports personal fees from Asahi Intecc, Kaneka, Medtronic, Stryker, and Terumo outside the submitted work. Dr Yamagami reported grants from Bristol Myers Squibb during the conduct of the study; 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
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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).
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