In patients with atrial fibrillation, women had a similar risk of stroke or systemic embolism compared with men (adjHR 0.91; 95% CI 0.74-1.12; P=0.38) during anticoagulation with apixaban or warfarin.
RCT (n=18,201)
double-blind
randomized
Yes
Does the efficacy and safety of apixaban compared with warfarin differ by sex in patients with atrial fibrillation?
Apixaban provides consistent efficacy and safety benefits over warfarin in both men and women with atrial fibrillation, despite women having lower baseline risks of mortality and bleeding.
Hazard Ratio: 0.91 (95% CI 0.74–1.12)
p-value: p=0.38
AIM: To assess clinical outcomes, efficacy, and safety according to sex during anticoagulation with apixaban compared with warfarin in patients with atrial fibrillation. METHODS AND RESULTS: Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) was a randomized, double-blind, placebo-controlled, multicentre trial that included 11 785 (64.7%) men and 6416 (35.3%) women with atrial fibrillation or flutter randomized to receive either warfarin or apixaban. The primary efficacy endpoint was stroke or systemic embolism; secondary efficacy endpoints were death from any cause and cardiovascular death. The primary safety endpoint was major bleeding; secondary safety endpoints were a composite of major bleeding and non-major clinically relevant bleeding. The risk of stroke or systemic embolism was similar in women vs. men adjusted hazard ratio (adjHR): 0.91; 95% confidence interval (CI): 0.74-1.12; P = 0.38. However, among patients with history of stroke or transient ischaemic attack, women had a lower risk of recurrent stroke compared with men (adjHR: 0.70; 95% CI: 0.50-0.97; P = 0.036). Women also had a lower risk of all-cause death (adjHR: 0.63; 95% CI: 0.55-0.73; P < 0.0001) and cardiovascular death (adjHR: 0.62; 95% CI: 0.51-0.75; P < 0.0001), and a trend towards less major bleeding (adjHR: 0.86; 95% CI: 0.74-1.01; P = 0.066) and major or non-major clinically relevant bleeding (adjHR: 0.89; 95% CI: 0.80-1.00; P = 0.049). The efficacy and safety benefits of apixaban compared with warfarin were consistent regardless of sex. CONCLUSION: In the ARISTOTLE trial, women had a similar rate of stroke or systemic embolism but a lower risk of mortality and less clinically relevant bleeding than men. The efficacy and safety benefits of apixaban compared with warfarin were consistent in men and women. TRIAL REGISTRATION: ARISTOTLE ClinicalTrials.gov number, NCT00412984.
Vinereanu et al. (Mon,) conducted a rct in atrial fibrillation or flutter (n=18,201). Female sex vs. Male sex was evaluated on stroke or systemic embolism (adjHR 0.91, 95% CI 0.74-1.12, p=0.38). In patients with atrial fibrillation, women had a similar risk of stroke or systemic embolism compared with men (adjHR 0.91; 95% CI 0.74-1.12; P=0.38) during anticoagulation with apixaban or warfarin.