Effectiveness and Safety of Rivaroxaban 15 or 20 mg Versus Vitamin K Antagonists in Nonvalvular Atrial Fibrillation

Abstract

Background and Purpose— We compared the 1-year safety and effectiveness of rivaroxaban 15 mg (R15) or rivaroxaban 20 mg (R20) to vitamin K antagonists (VKAs) in patients with nonvalvular atrial fibrillation. Methods— New user cohort study of patients dispensed R15 or R20 versus VKA in 2013 or 2014 for nonvalvular atrial fibrillation, followed 1 year in the French Système National des Données de Santé (66 million people). R15 and R20 users were matched 1:1 with VKA users on sex, age, date of first drug dispensing, and high-dimensional propensity score. Hazard ratios (95% CIs) for stroke and systemic embolism, major bleeding, and death were computed using Cox proportional hazards or models by Fine and Gray during exposure. Results— In 31 171 matched R20 and VKA, mean age, 71; 62% men; 76% with CHA 2 DS 2 -VASc ≥2; 5% HAS-BLED >3 (hypertension, abnormal renal and liver function, stroke, bleeding, labile INR, elderly, drugs or alcohol); incidence rates for stroke and systemic embolism were 1.5% and 1.9% (hazard ratio, 0.79 [0.69–0.90]); major bleeding, 1.5% and 2.2% (0.67 [0.59–0.77]); death, 3.9% and 5.8% (0.67 [0.61–0.73]). In 23 314 matched R15 and VKA patients, mean age, 80; 47% men; 93% with CHA 2 DS 2 -VASc ≥2 and 9% with HAS-BLED >3; incidence rates of stroke and systemic embolism were 2.3% and 2.1% (1.05 [0.92–1.21]); major bleeding, 2.4% and 2.9% (0.84 [0.74–0.96]); death, 9.1% and 10.8% (0.85 [0.79–0.90]). Numbers needed to treat to observe one fewer death (NNT) were 46 for R15 and 61 for R20. Conclusions— In real life in France over 2013 to 2015, R15 and R20 were at least as effective and safer than VKA. Clinical Trial Registration— URL: http://www.encepp.eu . Unique identifier: EUPAS14567.