Clinical outcomes in patients with atrial fibrillation according to sex during anticoagulation with apixaban or warfarin: a secondary analysis of a randomized controlled trial.

Published

Journal Article

To assess clinical outcomes, efficacy, and safety according to sex during anticoagulation with apixaban compared with warfarin in patients with atrial fibrillation.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.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.ARISTOTLE ClinicalTrials.gov number, NCT00412984.

Full Text

Duke Authors

Cited Authors

  • Vinereanu, D; Stevens, SR; Alexander, JH; Al-Khatib, SM; Avezum, A; Bahit, MC; Granger, CB; Lopes, RD; Halvorsen, S; Hanna, M; Husted, S; Hylek, EM; M─ârgulescu, AD; Wallentin, L; Atar, D

Published Date

  • December 2015

Published In

Volume / Issue

  • 36 / 46

Start / End Page

  • 3268 - 3275

PubMed ID

  • 26371113

Pubmed Central ID

  • 26371113

Electronic International Standard Serial Number (EISSN)

  • 1522-9645

International Standard Serial Number (ISSN)

  • 0195-668X

Digital Object Identifier (DOI)

  • 10.1093/eurheartj/ehv447

Language

  • eng