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Stroke. 2019 Sep;50(9):2469-2476. doi: 10.1161/STROKEAHA.119.025824. Epub 2019 Aug 8.

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

Author information

1
From the Bordeaux PharmacoEpi, INSERM CIC1401, CHU de Bordeaux, Université de Bordeaux, France (P.B., C.D.-P., M.-A.B., R.L., C.D.-P., N.M.).
2
Hôpital Trousseau-CHU de Tours, Service de cardiologie, Faculté de Médecine, Université François Rabelais, France (L.F.).
3
IHU Liryc, Electrophysiology and Heart Modeling Institute, Fondation Bordeaux Université/Bordeaux University Hospital (CHU), Electrophysiology and Ablation Unit, Centre de recherche Cardio-Thoracique de Bordeaux, INSERM U1045, Université de Bordeaux, France (F.S.).
4
Institut Pasteur de Lille, Inserm U744, Unité d'Epidémiologie et de Santé Publique, France (J.D.).
5
INSERM U1219, Université de Bordeaux, France (N.M.).

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 CHA2DS2-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 CHA2DS2-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.

KEYWORDS:

France; atrial fibrillation; humans; pharmacoepidemiology; rivaroxaban

PMID:
31390972
DOI:
10.1161/STROKEAHA.119.025824
Free PMC Article

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