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

Lutsey, Pamela L.; Zakai, Neil A.; MacLehose, Richard F.; Norby, Faye L.; Walker, Rob F.; Roetker, Nicholas S.; Adam, Terrence J.; Alonso, Alvaro

doi:10.1111/bjh.15857

Cited by 47Venous Thromboembolism Diagnosis and ManagementAtrial Fibrillation Management and OutcomesBlood Coagulation and Thrombosis Mechanisms

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

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Lutsey, Pamela L., Zakai, Neil A., MacLehose, Richard F., Norby, Faye L., Walker, Rob F., Roetker, Nicholas S., Adam, Terrence J., Alonso, Alvaro·2019·British Journal of Haematology

DOI 10.1111/bjh.15857PMC PMC6536346

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Abstract

Summary: 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.

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A total of 5 studies were included for analysis: 1 thrombophilia clinic registry review, 1 retrospective review of veterans, and 3 database studies from the United States and Denmark.
“A total of 5 studies were included for analysis: 1 study included a review of data from a thrombophilia clinic registry, 1 study included a review of retrospective data of veterans, and 3 were database studies from the United States and Denmark.”
From Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world (2019) · cites this paper as [14]
The Methods > Study population passage (page unavailable) identifies this paper as a retrospective cohort study using MarketScan health-claims databases, supporting its identification as a database study. It does not establish that five studies were included in the citing analysis or verify the claimed breakdown into a thrombophilia registry review, a veterans review, and three US and Danish database studies. (LLM, conf=0.84)
Experimental — accuracy not yet measured
The 5 selected studies assessed similar efficacy end points and outcomes but were slightly different in overall design and outcome definitions.
“Although the 5 selected studies 8-11,14 assessed similar efficacy end points and outcomes, they were slightly different in terms of overall design and outcome definitions (Table 1).”
From Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world (2019) · cites this paper as [14]
The Introduction and Methods describe this paper as a VTE anticoagulant comparison with a defined study design and hospitalised-bleeding outcome. It can therefore serve as one of the studies being compared, but it did not assess an efficacy endpoint such as recurrent VTE; its own text also cannot establish how all five studies’ designs and outcome definitions differed. (LLM, conf=0.84)
Experimental — accuracy not yet measured
The study by Lutsey et al was included only for major bleeding outcome because VTE events and minor bleeding events were not recorded.
“The study by Lutsey et al was included only for major bleeding outcome because the VTE events and minor bleeding events were not recorded. 14”
From Systematic review and meta-analysis of the efficacy and safety of apixaban compared to rivaroxaban in acute VTE in the real world (2019) · cites this paper as [14]
The Introduction and Methods (Identification of hospitalised bleeding events) show that the study evaluated major hospitalised bleeding, not minor bleeding or recurrent VTE as outcomes. But Methods (Study population) explicitly records initial VTE events, so the statement that VTE events were not recorded is too broad. The paper also does not establish that the unavailability of those outcomes was the citing authors’ reason for including the study only for major bleeding. (LLM, conf=0.83)
Experimental — accuracy not yet measured

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Abstract MP13: Comparative Effectiveness of Direct Oral Anticoagulants and Warfarin on Risk of Bleeding Resulting in Hospitalization Among Venous Thromboembolism Patients
Lutsey, P. L., Zakai, N. A., MacLehose, R. F., Norby, F. L., Walker, R. F., Roetker, N. S., Adam, T. J., & Alonso, Á. (2018) · Circulation · doi:10.1161/circ.137.suppl_1.mp13
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Bleeding Risk with Apixaban vs. Rivaroxaban in Acute Venous Thromboembolism
Castellucci, L. A., Chen, V. M. Y., Kovacs, M. J., Lazo‐Langner, A., Greenstreet, P., Kahn, S. R., Côté, B., Schulman, S., de Wit, K., Douketis, J. D., et al. (2026) · Zurich Open Repository and Archive (University of Zurich) · doi:10.5167/uzh-436632

Authors: Lutsey, P. L., Zakai, N. A., MacLehose, R. F., Norby, F. L., Walker, R. F., Roetker, N. S., Adam, T. J., & Alonso, A.
Affiliations: University of Minnesota (US)
University of Vermont (US)
Hennepin Healthcare Research Institute (US)
Department of Epidemiology Rollins School of Public Health Emory University Atlanta GA USA
Corresponding author: Lutsey, Pamela L.
ORCID: Lutsey, Pamela L.
Zakai, Neil A.
MacLehose, Richard F.
Norby, Faye L.
Walker, Rob F.
Roetker, Nicholas S.
Adam, Terrence J.
Venue: British Journal of Haematology
Publisher: Wiley
Published: 2019-03-28
Volume: 185
Issue: 5
Pages: 903-911
ISSN: 0007-1048 (ISSN-L)
1365-2141
DOI: 10.1111/bjh.15857
PMC: PMC6536346
OpenAlex: W2929067776
Cited by: 47
References: 39
Citations by year: 2026: 6 · 2025: 3 · 2024: 3 · 2023: 9 · 2022: 12 · 2021: 6 · 2020: 6 · 2019: 2
FWCI: 4.98
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations: British Journal of Haematology (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Heart, Lung, and Blood Institute (R01‐HL131579, R01‐HL122200)
Topics: Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords: venous thromboembolism, oral anticoagulants, apixaban, rivaroxaban, warfarin, direct oral anticoagulants
MeSH terms: Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Anticoagulants, Female, Hemorrhage, Hospitalization, Humans, Male, Middle Aged, Retrospective Studies, Risk Factors, Venous Thromboembolism, Young Adult

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

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