Abstract 15930: Efficacy and Safety of Apixaban in Patients With Atrial Fibrillation According to Sex: Results From the ARISTOTLE Trial
Background: Prior studies have shown that in patients with AF there may be important differences in clinical outcomes between men and women. We assessed clinical events as well as the efficacy and safety of apixaban compared with warfarin according to sex in patients enrolled in the ARISTOTLE trial.
Methods: Patients enrolled in the ARISTOTLE trial (6416 women, 11785 men) were analyzed. The primary efficacy outcome was stroke or systemic embolism. Secondary efficacy endpoints were death of any cause and CV death. The primary safety outcome was major bleeding. Cox proportional hazards regression models were used to assess associations between clinical outcomes and sex as well as sex-by-treatment interactions.
Results: Women were older than men (72 vs. 69 yrs; p<0.001). The prevalence of prior stroke/ embolic events (20.6% vs. 18.8%), hypertension (89.7% vs. 86.2%), and renal failure (69.6% vs. 52.5%) was higher in women than in men, while men had a higher prevalence of heart failure (36.1% vs. 34.3%), ischemic heart disease (38.5% vs. 29.8%), and bleeding history (17.4% vs. 15.4%). Compared with men, women had a higher baseline stroke risk according to CHADS2 (score ≥3: 34.1% vs. 28.1%; p<0.001), but similar bleeding risk according to the HAS-BLED score. However, the rates of observed stroke and systemic embolic events (HR 1.16, 95% CI 0.97-1.40; p=0.11) and major bleeding (HR 0.98, 95% CI 0.85-1.14; p=0.84) were similar in women versus men. Overall, women had lower risk of death (HR 0.82, 95% CI 0.73-0.92; p=0.001) and CV related death (HR 0.75, 95% CI 0.64-0.89; p=0.001) compared with men. The efficacy and safety of apixaban compared with warfarin were consistent, regardless of sex (Figure).
Conclusions: In ARISTOTLE, the risks of stroke and of major bleeding were similar in women and men despite the lower mortality (both of any cause and CV) in women compared with men. The efficacy and safety benefits of apixaban compared with warfarin were consistent in men and women.
- © 2013 by American Heart Association, Inc.