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Clinical Research Study| Volume 131, ISSUE 8, P933-938.e1, August 2018

Effectiveness and Safety of Rivaroxaban Versus Warfarin in Frail Patients with Venous Thromboembolism

Published:March 08, 2018DOI:https://doi.org/10.1016/j.amjmed.2018.02.015
Effectiveness and Safety of Rivaroxaban Versus Warfarin in Frail Patients with Venous Thromboembolism
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      Abstract

      Purpose

      Frailty predicts poorer outcomes in patients receiving anticoagulation. We assessed the effectiveness and safety of rivaroxaban vs warfarin in frail patients experiencing venous thromboembolism.

      Methods

      Using US MarketScan claims data from January 2012-December 2016, we identified frail patients (using the Johns Hopkins Claims-Based Frailty Indicator score) who had ≥1 primary hospitalization/emergency department visit diagnosis codes for venous thromboembolism, received rivaroxaban or warfarin as their first outpatient oral anticoagulant within 30 days of the index event, and had ≥12 months of insurance prior to the index venous thromboembolism. Differences in baseline covariates between cohorts were adjusted using inverse probability of treatment weights based on propensity scores. The primary endpoint was the composite of recurrent venous thromboembolism or major bleeding. Patient claims were tracked for up to 12 months after the index venous thromboembolism or until endpoint occurrence oral anticoagulant discontinuation/switch, insurance disenrollment, or end of follow-up. Cox regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs).

      Results

      Of 58,089 incident venous thromboembolism patients identified, 6869 (1365 rivaroxaban and 5504 warfarin users) were classified as frail. Rivaroxaban reduced patients' hazard of the composite of recurrent venous thromboembolism or major bleeding (HR 0.75; 95% CI, 0.57-0.98) and recurrent venous thromboembolism alone (HR 0.65; 95% CI, 0.44-0.97) compared with warfarin. No significant difference in major bleeding was observed between cohorts (HR 0.88; 95% CI, 0.61-1.27).

      Conclusions

      Frail patients experiencing a venous thromboembolism and given rivaroxaban experience less recurrent venous thromboembolism, with at least as good bleeding outcomes, as patients prescribed warfarin.

      Keywords

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      References

        • Villacampa-Fernández P.
        • Navarro-Pardo E.
        • Tarín J.J.
        • Cano A.
        Frailty and multimorbidity: two related yet different concepts.
        Maturitas. 2017; 95: 31-35
        View in Article
        • Bandeen-Roche K.
        • Xue Q.L.
        • Ferrucci L.
        • et al.
        Phenotype of frailty: characterization in the women's health and aging studies.
        J Gerontol A Biol Sci Med Sci. 2006; 61: 262-266
        View in Article
        • Prins M.H.
        • Lensing A.W.
        • Bauersachs R.
        • et al.
        Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies.
        Thromb J. 2013; 11: 21
        View in Article
        • Segal J.B.
        • Chang H.-Y.
        • Du Y.
        • Walston J.D.
        • Carlson M.C.
        • Varadhan R.
        Development of a claims-based frailty indicator anchored to a well-established frailty phenotype.
        Med Care. 2017; 55: 716-722
        View in Article
        • Hansen L.
        The Truven Health MarketScan Databases for life sciences researchers.
        (Available at)
        https://truvenhealth.com/Portals/0/Assets/2017-MarketScan-Databases-Life-Sciences-Researchers-WP.pdf
        Date accessed: December 25, 2017
        View in Article
        • White R.H.
        • Garcia M.
        • Sadeghi B.
        • et al.
        Evaluation of the predictive value of ICD-9-CM codedadministrative data for venous thromboembolism in the United States.
        Thromb Res. 2010; 126: 61-67
        View in Article
        • Fang M.C.
        • Fan D.
        • Sung S.H.
        • et al.
        Validity of using inpatient and outpatient administrative codes to identify acute venous thromboembolism: The CVRN VTE Study.
        Med Care. 2017; 55: e137-e143
        View in Article
        • Fried L.P.
        • Tangen C.M.
        • Walston J.
        • et al.
        Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype.
        J Gerontol A Biol Sci Med Sci. 2001; 56: M146-M156
        View in Article
        • Cunningham A.
        • Stein C.M.
        • Shung C.P.
        • Daugherty J.R.
        • Smalley W.E.
        • Ray W.A.
        An automated database case definition for serious bleeding related to oral anticoagulant use.
        Pharmacoepidemiol Drug Saf. 2011; 20: 560-566
        View in Article
        • Austin P.C.
        An introduction to propensity score methods for reducing the effects of confounding in observational studies.
        Multivariate Behav Res. 2011; 46: 399-424
        View in Article
        • Benchimol E.I.
        • Smeeth L.
        • Guttmann A.
        • et al.
        The Reporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement.
        PLoS Med. 2015; 12 (e1001885)
        View in Article
        • Geldhof V.
        • Vandenbriele C.
        • Verhamme P.
        • Vanassche T.
        Venous thromboembolism in the elderly: efficacy and safety of non-VKA oral anticoagulants.
        Thromb J. 2014; 12: 21
        View in Article
        • Gandhi S.K.
        • Salmon W.
        • Kong S.X.
        • Zhao S.Z.
        Administrative databases and outcomes assessment: an overview of issues and potential utility.
        J Manag Care Spec Pharm. 1999; 5: 215-222
        View in Article

      Article info

      Publication history

      Published online: March 08, 2018

      Footnotes

      Funding: This study was supported by Bayer AG, Berlin, Germany. The funder had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.

      Conflicts of Interest: CIC has received grant funding and consultancy honoraria from Bayer AG, Janssen Scientific Affairs LLC, and Boehringer Ingelheim Pharmaceuticals Inc. AGGT has received speaker's honoraria and consultancy fees from, and participated in scientific advisory boards for, Bayer HealthCare Pharmaceuticals and Janssen Research and Development, LLC, and has been a consultant for Bayer HealthCare, Janssen Pharmaceutical Research and Development, Astellas, Portola, and Takeda. JB-W has received research grants from Bayer AG, Boehringer Ingelheim, Daiichi Sankyo, Pfizer, Portola Pharmaceuticals, and has served as a consultant to and has received honoraria from Bayer AG, Boehringer Ingelheim, Daiichi Sankyo, Pfizer, Portola Pharmaceuticals, CSL Behring, and Medscape. TJB has no disclosures germane to this manuscript.

      Authorship: All authors had access to the data and participated in the writing, critical revision, and decision to submit the manuscript.

      Identification

      DOI: https://doi.org/10.1016/j.amjmed.2018.02.015

      Copyright

      © 2018 Elsevier Inc. All rights reserved.

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