Risk of hospitalised bleeding in comparisons of oral anticoagulant options for the primary treatment of venous thromboembolism

• Type of Material: Article
• Authors: Pamela L. Lutsey, University of Minnesota; Neil A. Zakai, University of Vermont; Richard F. MacLehose, University of Minnesota; Faye L. Norby, University of Minnesota; Rob F. Walker, University of Minnesota; Nicholas S. Roetker, University of Minnesota; Terrence Adam, University of Minnesota; Alvaro Alonso, Emory University
• Language: English
• Date: 2019-06-01
• Publisher: Wiley
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2019 British Society for Haematology and John Wiley & Sons LtdBritish Journal of Haematology.
• Final Published Version (URL): http://dx.doi.org/10.1111/bjh.15857
• Title of Journal or Parent Work: British Journal of Haematology
• Volume: 185
• Issue: 5
• Start Page: 903
• End Page: 911
• Grant/Funding Information: This work was supported by NIH National Heart Lung and Blood Institute grants R01-HL131579 and R01-HL122200.
• Keywords: Dabigatran; oral anticoagulant; Rivaroxaban; rivaroxaban; Life Sciences & Biomedicine; venous thromboembolism; Therapy; Adherence; Science & Technology; Hematology; apixaban; Disease; Wafarin; comparative effectiveness
• Research Categories: Health Sciences, Public Health; Health Sciences, Epidemiology; Health Sciences, Health Care Management; Health Sciences, Pharmacy

Abstract

Understanding of the comparative bleeding risks of oral anticoagulant (OAC) therapies for the primary treatment of venous thromboembolism (VTE) is limited. Therefore, among anticoagulant-naïve VTE patients, we conducted comparisons of apixaban, rivaroxaban and warfarin on the rate of hospitalised bleeding within 180 days of OAC initation. MarketScan databases for the time-period from 2011 to 2016 were used and, for each OAC comparison, new users were matched with up to five initiators of a different OAC. The final analysis included 83 985 VTE patients, who experienced 1944 hospitalised bleeding events. In multivariable-adjusted Cox regression models, rate of hospitalised bleeding was lower among new users of apixaban when compared to new users of rivaroxaban [hazard ratio (95% confidence interval) 0·58 (0·41–0·80)] or warfarin [0·68 (0·50–0·92)]. Overall, the hospitalised bleeding rate was similar when comparing new users of rivaroxaban to new users of warfarin [0·98 (0·68–1·11)], though there was some suggestion that rivaroxaban was associated with lower bleeding risk among younger individuals. Findings from this large real-world population concur with results from the randomised trial which found lower bleeding risk with apixaban versus warfarin and, for the first time, reveal a lower risk of bleeding in a comparison of apixaban versus rivaroxaban.