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Observational Study
. 2017 Sep 6;17(1):238.
doi: 10.1186/s12872-017-0672-5.

Comparative effectiveness of rivaroxaban versus warfarin or dabigatran for the treatment of patients with non-valvular atrial fibrillation

Faye L Norby  1 , Lindsay G S Bengtson  2 , Pamela L Lutsey  3 , Lin Y Chen  4 , Richard F MacLehose  3 , Alanna M Chamberlain  5 , Ian Rapson  3 , Alvaro Alonso  6
Affiliations
Observational Study

Comparative effectiveness of rivaroxaban versus warfarin or dabigatran for the treatment of patients with non-valvular atrial fibrillation

Faye L Norby et al. BMC Cardiovasc Disord. .

Abstract

Background: Rivaroxaban is an oral anticoagulant approved in the US for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). We determined the effectiveness and associated risks of rivaroxaban versus other oral anticoagulants in a large real-world population.

Methods: We selected NVAF patients initiating oral anticoagulant use in 2010-2014 enrolled in MarketScan databases. Rivaroxaban users were matched with warfarin and dabigatran users by age, sex, enrolment date, anticoagulant initiation date, and high-dimensional propensity score. Study endpoints, including ischemic stroke, intracranial bleeding (ICB), myocardial infarction (MI), and gastrointestinal (GI) bleeding, were identified from inpatient diagnostic codes. Multivariable Cox models were used to assess associations between type of anticoagulant and outcomes.

Results: The analysis included 44,340 rivaroxaban users matched to 89,400 warfarin and 16,957 dabigatran users (38% female, mean age 70) with 12 months of mean follow-up. Anticoagulant-naïve rivaroxaban initiators, but not those switching from warfarin, had lower risk of ischemic stroke [hazard ratio (HR) (95% confidence interval (CI)): 0.75 (0.62, 0.91)] and ICB [HR (95%CI): 0.55, (0.39, 0.78)] than warfarin users. In contrast, anticoagulant-experienced rivaroxaban initiators had higher risk of GI bleeding than warfarin users [HR (95%CI): 1.55 (1.32, 1.83)]. Endpoint rates were similar when comparing anticoagulant-naïve rivaroxaban and dabigatran initiators, with the exception of higher GI bleeding risk in rivaroxaban users [HR (95%CI) 1.28 (1.06, 1.54)]. There were no significant differences in the risk of MI among the comparison groups.

Conclusion: In this large real-world sample of NVAF patients, effectiveness and risks of rivaroxaban versus warfarin differed by prior anticoagulant status, while effectiveness of rivaroxaban versus dabigatran differed in GI bleeding risk.

Keywords: Dabigatran; Non-valvular atrial fibrillation; Rivaroxaban; Stroke; Warfarin.

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Conflict of interest statement

Ethics approval and consent to participate

All patient information is Health Insurance Portability and Accountability Act compliant, de-identified, commercially available secondary data, and therefore the Institutional Review Board at the University of Minnesota deemed this analysis exempt from review.

Consent for publication

Not applicable.

Competing interests

Dr. Bengtson is an employee of Optum. All other authors have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Adjusted hazard ratios (95% confidence intervals) of outcomes among anticoagulant users, stratified by subgroups, MarketScan, 2010–2014. Panel a: New rivaroxaban users vs. new warfarin users. Panel b: Patients who switched from warfarin to rivaroxaban vs. persistent warfarin users. Panel c: New rivaroxaban users vs. new dabigatran users
See this image and copyright information in PMC

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