Abstract 14523: Two-Year Benefit-Risk of Standard and Reduced Doses of Rivaroxaban versus Vitamin-K Antagonists in Non-Valvular Atrial Fibrillation: A Cohort Study in the French Nationwide Claims Database

• Published in: Circulation (New York, N.Y.) Vol. 138; no. Suppl_1 Suppl 1; p. A14523
• Main Authors: Moore, Nicholas, Fauchier, Laurent, Dureau-Pournin, Caroline, Bernard, Marie-Agnès, Lassalle, Régis, Sacher, Frédéric, Dallongeville, Jean, Droz-Perroteau, Cécile, Blin, Patrick
• Format: Journal Article
• Language: English
• Published: by the American College of Cardiology Foundation and the American Heart Association, Inc 06.11.2018
• ISSN: 0009-7322; 1524-4539

IntroductionReal-life benefit and risk for stroke prevention in non-valvular atrial fibrillation (NVAF) of rivaroxaban 20mg (R20), the standard dose, and rivaroxaban 15mg (R15), the recommended dose for patients with moderate or severe renal failure, remain uncertain.ObjectivesThe objective was to compare the 2-year risk of major events in NVAF new users of R20 or R15 versus vitamin K antagonists (VKA) in real-life setting.MethodsA cohort of R20, R15 or VKA new users for NVAF in 2013 was identified and followed for 2 years in SNDS, the French nationwide claims database. NVAF was defined from long-term disease registration, hospitalisation diagnosis or procedure for atrial fibrillation, without rheumatic valve disease or valve replacement (3-year history). Rivaroxaban and VKA patients were 1:1 matched on gender, age, date of the first drug dispensing, and high-dimensional propensity score (hdPS) including individual risk factors from CHA2DS2-VASc and HAS-BLED scores. Hazard Ratios (HR) [95% Confidence Interval (CI)] were estimated on-treatment, using Cox proportional hazards risk or Fine and Gray models.ResultsOf 118,048 new anticoagulant users for NVAF in 2013, 15,680 and 12,018 per arm were matched for R20 versus VKA and R15 versus VKA, respectively, with small or no standardized differences between groups, and a good overlap of hdPS distributions. Matched patients of R20 and R15 comparisons, had mean age 71.3 and 80.4 years, with 75.9% and 93.2% CHA2DS2-VASc ≥ 2 and 25.7% and 38.5% HAS-BLED ≥ 3, respectively. For R20 versus VKA and R15 versus VKA, there was no difference for stroke and systemic embolism (0.99 [0.84-1.16] and 1.14 [0.97-1.34], respectively), but a significantly lower risk of major bleeding for both doses of rivaroxaban (0.69 [0.59-0.81] and 0.80 [0.69-0.93]), as well as of death (0.67 [0.61-0.74] and 0.79 [0.73-0.85]) and for the composite of the 3 major events (0.73 [0.68-0.79] and 0.83 [0.77-0.88]).ConclusionsThis nationwide cohort study of new anticoagulant users for NVAF shows for both doses of rivaroxaban (20mg and 15mg) a better risk profile with fewer major bleedings compared to VKA, no difference for stroke and systemic embolisms, and a better benefit-risk with fewer deaths and the 3 major events taken together.