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

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...

Physicians' Use of Heparin Following Thrombolytic Therapy: An International Perspective.

Background: The current prevalence, timing, and route of heparin use after thrombolytic therapy for acute myocardial infarction both within and outside the United States (U.S.) have not been extensively studied. Method: An 18-item questionnaire was mailed to cardiologists and emergency medicine practitioners in the U.S. and to physicians in 5 countries considering participation in an international trial of thrombolytic therapy. Results: Almost all used some form of heparin after recombinant tissue-plasminogen activator; 8% withheld heparin after streptokinase. Non-U.S. physicians used subcutaneous heparin more frequently than did U.S. physicians (26% vs. 4%). Time to heparin initiation varied greatly. Most physicians used the activated partial thromboplastin time to monitor anticoagulation, although there was little consensus about the appropriate way to determine the efficacy of heparin therapy. Conclusions: This survey shows considerable disagreement about the preferred administration of heparin among physicians treating patients with myocardial infarction. This lack of agreement reflects uncertainty about how heparin therapy should be used. When the results of well-designed clinical trials examining the optimal dosing, timing, and monitoring of heparin therapy have been published, perhaps the clinical community can reach a consensus.