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Effectiveness and safety of rivaroxaban versus warfarin in obese patients with acute venous thromboembolism: analysis of electronic health record data


There is limited data evaluating clinical outcomes of rivaroxaban versus warfarin in obese patients with venous thromboembolism (VTE). Our objective was to evaluate the effectiveness and safety of rivaroxaban versus warfarin in obese VTE patients. We performed a cohort analysis using Optum® De-Identified Electronic Health Record data from 11/1/2012 to 9/30/2018. Patients with a body mass index (BMI) ≥ 30 kg/m2 admitted to the hospital, emergency department or observation unit for VTE, prescribed rivaroxaban or warfarin as their first oral anticoagulant (OAC) within 7-days and had ≥12-months of EHR activity prior were included. We excluded patients with OAC use at baseline or cancer. Patients were 1:1 matched (standard differences<0.10). Primary outcomes were recurrent VTE and major bleeding at 3-, 6- and 12-months using an intent-to-treat approach. Subanalyses of BMI 30.0–34.9, 35.0–39.9 and ≥ 40 kg/m2 were performed. Risk was compared using Cox regression and reported as hazard ratios (HRs) with 95% confidence intervals (CI). We identified 6755 rivaroxaban and 6755 warfarin users with BMI ≥ 30 kg/m2 and incident VTE. At 3-, 6- and 12-months, rivaroxaban was associated with a reduced hazard of recurrent VTE compared to warfarin (HR 0.61, 95%CI   0.51–0.72; HR 0.65, 95%CI  0.55–0.77; HR 0.63, 95%CI  0.54–0.74) with no difference in major bleeding (HR  0.99, 95%CI  0.68–1.44; HR 0.90, 95%CI  0.64–1.26; HR 1.00, 95%CI  0.73–1.36). No statistical difference was found across BMI categories for either recurrent VTE (p-interaction≥0.43) or major bleeding (p-interaction ≥ 0.58) at any time point. In obese VTE patients, prescription of rivaroxaban was associated with a significantly reduced risk of recurrent VTE versus warfarin, without impacting major bleeding. Our findings remained consistent across BMI classes.

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Data availability

Data used in this study were obtained from Optum® under a license to Janssen Pharmaceuticals (and provided to Dr. Coleman under a third-party agreement) and are not publicly available.


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This study was funded by Janssen Scientific Affairs, LLC, Titusville, NJ, USA.

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Authors and Affiliations



OSC, CIC, JBW, VA, DM and KTM conceptualized and designed the study. OSC, CIC and TJB analyzed the data. Data interpretation was done by all authors. The manuscript was written primarily by OSC and CIC; all authors contributed to revisions. All authors substantially contributed to this project, read and approved the manuscript and assume responsibility for the contents of the manuscript.

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Correspondence to Craig I. Coleman.

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Conflict of interest

C. I. Coleman has received grant funding and consultancy fees from Janssen Scientific Affairs LLC, Titusville, NJ, Bayer AG, Berlin, Germany; Portola Pharmaceuticals, South San Francisco, CA; and speaker fees from Medscape Inc. J. Beyer-Westendorf has grant funding and consultancy fees from Bayer AG, Berlin, Germany; Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT; Pfizer New York, NY; Daiichi Sankyo, Basking Ridge, NJ; and Portola Pharmaceuticals, South San Francisco, CA. V. Ashton and D. Milentijevic are employees of Janssen Scientific Affairs LLC, Titusville, NJ. KT. Moore is an employee of Janssen Pharmaceuticals Inc., Titusville, NJ. O. S. Costa and T. J. Bunz have no declarations-of-interest.

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Costa, O.S., Beyer-Westendorf, J., Ashton, V. et al. Effectiveness and safety of rivaroxaban versus warfarin in obese patients with acute venous thromboembolism: analysis of electronic health record data. J Thromb Thrombolysis 51, 349–358 (2021).

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  • Anticoagulants
  • Rivaroxaban
  • Warfarin
  • Obesity
  • Venous thromboembolism