Racial disparities in the incidence and risk factors of major bleeding during extended anticoagulant therapy for venous thromboembolism

Duale Omar¹, Michael J Kovacs², Alejandro Lazo-Langner², David R Anderson³, Susan R Kahn⁴, Lana A Castellucci⁵, Jeannot Schmidt⁶, Antoine Elias⁷, Marc Righini⁸, Thomas L Ortel⁹, Menno V Huisman¹⁰, Marc Carrier¹¹, Jude-Mary Cénat¹², Ranjeeta Mallick¹³, Marc A Rodger⁷, Grégoire Le Gal¹⁴, Philip S Wells¹⁵, Yan Xu¹⁶

Affiliations

¹ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada.
² Department of Medicine, Western University, London, Ontario, Canada.
³ Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
⁴ Department of Medicine, McGill University, Montreal, Québec, Canada. Electronic address: https://x.com/SusanRKahn1.
⁵ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: https://x.com/LanaCastellucci.
⁶ Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont, France.
⁷ Centre Hospitalier Intercommunal de Toulon, Toulon, France.
⁸ Department of Medicine, University of Geneva, Geneva, Switzerland.
⁹ Department of Medicine, Duke University, Durham, North Carolina, USA.
¹⁰ Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
¹¹ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: https://x.com/MarcCarrier1.
¹² Interdisciplinary Centre for Black Health, School of Psychology, Faculty of Social Sciences, University of Ottawa, Ontario, Canada.
¹³ School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹⁴ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
¹⁵ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: https://x.com/PhilWellsMD1.
¹⁶ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: yaxu@toh.ca.

PMID: 40769433
DOI: 10.1016/j.jtha.2025.07.026

Free article

Comparative Study

Racial disparities in the incidence and risk factors of major bleeding during extended anticoagulant therapy for venous thromboembolism

Duale Omar et al. J Thromb Haemost. 2025 Nov.

Free article

. 2025 Nov;23(11):3590-3600.

doi: 10.1016/j.jtha.2025.07.026. Epub 2025 Aug 5.

Authors

Affiliations

¹ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada.
² Department of Medicine, Western University, London, Ontario, Canada.
³ Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.
⁴ Department of Medicine, McGill University, Montreal, Québec, Canada. Electronic address: https://x.com/SusanRKahn1.
⁵ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: https://x.com/LanaCastellucci.
⁶ Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont, France.
⁷ Centre Hospitalier Intercommunal de Toulon, Toulon, France.
⁸ Department of Medicine, University of Geneva, Geneva, Switzerland.
⁹ Department of Medicine, Duke University, Durham, North Carolina, USA.
¹⁰ Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
¹¹ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: https://x.com/MarcCarrier1.
¹² Interdisciplinary Centre for Black Health, School of Psychology, Faculty of Social Sciences, University of Ottawa, Ontario, Canada.
¹³ School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
¹⁴ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
¹⁵ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: https://x.com/PhilWellsMD1.
¹⁶ Department of Medicine, Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: yaxu@toh.ca.

PMID: 40769433
DOI: 10.1016/j.jtha.2025.07.026

Abstract

Background: Guidelines recommend extended anticoagulation after a first unprovoked venous thromboembolism (VTE) for individuals at low risk of bleeding. However, racial disparities in bleeding risks during extended treatment remain understudied.

Objectives: To compare risks of anticoagulant-associated bleeding and performance of a risk assessment model by racial group during extended VTE treatment.

Methods: We analyzed 2 prospective cohorts of patients (223 Black participants and 4314 White participants) with a first unprovoked/weakly provoked VTE who continued anticoagulation after ≥3 months of initial treatment. Primary outcome was adjudicated International Society on Thrombosis and Haemostasis-defined major bleeding. Secondary outcomes included intracranial hemorrhage, fatal bleeding, and clinically relevant nonmajor bleeding. We determined incidence and hazard ratios (HRs) by race, then adjusted for bleeding risk factors that included the Creatinine, Hemoglobin, Age, antiPlatelet model.

Results: Black participants had higher prevalence of bleeding risk factors and a 1.9-fold higher risk of major bleeding (HR, 1.87; 95% CI, 1.04-3.36) compared with White participants. Adjustment attenuated racial difference for major bleeding but not intracranial hemorrhage (adjusted HR, 2.35; 95% CI, 1.23-4.48). Among those classified as low risk by Creatinine, Hemoglobin, Age, antiPlatelet model, Black participants had numerically higher major bleeding incidence than White participants (2.5 vs 1.1 per 100 person-years). We did not observe racial disparities in fatal bleeding or clinically relevant nonmajor bleeding.

Conclusion: Black individuals on extended anticoagulation have higher risk of major bleeding compared with White individuals. This effect appears to persist in those classified as low risk for bleeding. Risk assessment models for anticoagulant-associated bleeding that are generalizable to racialized populations are needed.

Keywords: ethnic and racial minorities; hemorrhage; venous thromboembolism.

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Conflict of interest statement

Declaration of competing interests L.A.C.’s research institution has received honoraria from Bayer, BMS-Pfizer, The Academy for Continued Advancement in Healthcare Education, Amag Pharmaceutical, LEO Pharma, Sanofi, Valeo Pharma, and Servier. M.C. reports research grants from Pfizer, Bristol Myers Squibb, and LEO Pharma and consultancy honoraria from Pfizer, Bayer, Sanofi, Servier, and LEO Pharma. P.S.W. reports consulting in a legal case for Bayer Healthcare. All other authors have no financial or personal relationships or affiliations that could influence the decisions and work on this article.

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Racial disparities in the incidence and risk factors of major bleeding during extended anticoagulant therapy for venous thromboembolism

Affiliations

Racial disparities in the incidence and risk factors of major bleeding during extended anticoagulant therapy for venous thromboembolism

Authors

Affiliations

Abstract

Conflict of interest statement

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Full Text Sources

Medical