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Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data

  • Original Research Article
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Abstract

Background

No studies have directly compared the effectiveness and safety of dabigatran and rivaroxaban using US Medicare data.

Objective

Our objective was to compare effectiveness and safety between rivaroxaban 20 mg/dabigatran 150 mg and rivaroxaban 15 mg/dabigatran 75 mg among patients with atrial fibrillation (AF).

Methods

Using 2010–2013 US Medicare Part D data, we selected patients with AF initiating dabigatran 150/75 mg or rivaroxaban 20/15 mg between 4 November 2011 (when rivaroxaban was approved) and 31 December 2013. Our sample included 7322 patients receiving dabigatran 150 mg, 5799 patients receiving rivaroxaban 20 mg, 1818 receiving dabigatran 75 mg, and 2568 receiving rivaroxaban 15 mg. We followed them until stroke, other thromboembolic events, bleeding, discontinuation or switch of an anticoagulant, death, or 31 December 2013. We constructed Cox proportional hazard models with propensity score weighting to compare clinical outcomes between groups.

Results

There was no difference in the risk of stroke between dabigatran 150 mg and rivaroxaban 20 mg (hazard ratio [HR] 1.05; 95 % confidence interval [CI] 0.97–1.13) or between dabigatran 75 mg and rivaroxaban 15 mg (HR 1.05; 95 % CI 0.94–1.18). Compared with dabigatran 150 mg, rivaroxaban 20 mg was associated with a higher risk of other thromboembolic events (HR 1.28; 95 % CI 1.14–1.44), major bleeding (HR 1.32; 95 % CI 1.17–1.50), and death (HR 1.36; 95 % CI 1.19–1.56). The risk of thromboembolic events other than stroke (HR 1.37; 95 % CI 1.15–1.62), major bleeding (HR 1.51; 95 % CI 1.25–1.82), and death (HR 1.21; 95 % CI 1.04–1.41) was also higher for rivaroxaban 15 mg than for dabigatran 75 mg.

Conclusions

There was no difference in stroke prevention between rivaroxaban and dabigatran; however, rivaroxaban was associated with a higher risk of thromboembolic events other than stroke, death, and bleeding.

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Authors and Affiliations

  1. Department of Pharmacy and Therapeutics, School of Pharmacy, University of Pittsburgh, 3501 Terrace St, Pittsburgh, PA, 15261, USA

    Inmaculada Hernandez

  2. Department of Health Policy and Management, Graduate School of Public Health, University of Pittsburgh, 130 De Soto Street, Crabtree Hall A664, Pittsburgh, PA, 15261, USA

    Yuting Zhang

Authors
  1. Inmaculada Hernandez
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Correspondence to Yuting Zhang.

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Funding

The authors acknowledge funding from the Commonwealth Fund (Grants 20150380 and 20130660), the Agency for Healthcare Research and Quality (No. R01 HS018657), and from the National Institute of Mental Health (No. R21 MH100721). IH has received a scholarship from “La Caixa” Foundation (Spain).

Conflict of interest

IH and YZ have no conflicts of interest that are directly relevant to the content of this article.

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Hernandez, I., Zhang, Y. Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data. Am J Cardiovasc Drugs 17, 37–47 (2017). https://doi.org/10.1007/s40256-016-0189-9

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  • DOI: https://doi.org/10.1007/s40256-016-0189-9

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