Cited by 808Venous Thromboembolism Diagnosis and ManagementBlood Coagulation and Thrombosis MechanismsAtrial Fibrillation Management and Outcomes

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Long-Term, Low-Intensity Warfarin Therapy for the Prevention of Recurrent Venous Thromboembolism

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Ridker, Paul M, Goldhaber, Samuel Z., Danielson, Ellie, Rosenberg, Yves, Eby, Charles S., Deitcher, Steven R., Cushman, Mary, Moll, Stephan, Kessler, Craig M., Elliott, C. Gregory, Paulson, Rolf, Wong, Turnly, Bauer, Kenneth A., Schwartz, Bruce A., Miletich, Joseph P., Bounameaux, Henri, Glynn, Robert J.·2003·New England Journal of Medicine

DOI 10.1056/nejmoa035029

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Abstract

BACKGROUND: Standard therapy to prevent recurrent venous thromboembolism includes 3 to 12 months of treatment with full-dose warfarin with a target international normalized ratio (INR) between 2.0 and 3.0. However, for long-term management, no therapeutic agent has shown an acceptable benefit-to-risk ratio. METHODS: Patients with idiopathic venous thromboembolism who had received full-dose anticoagulation therapy for a median of 6.5 months were randomly assigned to placebo or low-intensity warfarin (target INR, 1.5 to 2.0). Participants were followed for recurrent venous thromboembolism, major hemorrhage, and death. RESULTS: The trial was terminated early after 508 patients had undergone randomization and had been followed for up to 4.3 years (mean, 2.1). Of 253 patients assigned to placebo, 37 had recurrent venous thromboembolism (7.2 per 100 person-years), as compared with 14 of 255 patients assigned to low-intensity warfarin (2.6 per 100 person-years), a risk reduction of 64 percent (hazard ratio, 0.36 [95 percent confidence interval, 0.19 to 0.67]; P<0.001). Risk reductions were similar for all subgroups, including those with and those without inherited thrombophilia. Major hemorrhage occurred in two patients assigned to placebo and five assigned to low-intensity warfarin (P=0.25). Eight patients in the placebo group and four in the group assigned to low-intensity warfarin died (P=0.26). Low-intensity warfarin was thus associated with a 48 percent reduction in the composite end point of recurrent venous thromboembolism, major hemorrhage, or death. According to per-protocol and as-treated analyses, the reduction in the risk of recurrent venous thromboembolism was between 76 and 81 percent. CONCLUSIONS: Long-term, low-intensity warfarin therapy is a highly effective method of preventing recurrent venous thromboembolism.

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Authors: Ridker, P. M., Goldhaber, S. Z., Danielson, E., Rosenberg, Y., Eby, C. S., Deitcher, S. R., Cushman, M., Moll, S., Kessler, C. M., Elliott, C. G., Paulson, R., Wong, T., Bauer, K. A., Schwartz, B. A., Miletich, J. P., Bounameaux, H., & Glynn, R. J.
Affiliations: Brigham and Women's Hospital (US)
National Institutes of Health (US)
Washington University in St. Louis (US)
Cleveland Clinic (US)
University of Vermont (US)
University of North Carolina at Chapel Hill (US)
Georgetown University Medical Center (US)
LDS Hospital (US)
Altru Health System (US)
St. Boniface Hospital (CA)
Beth Israel Deaconess Medical Center (US)
University Hospital of Geneva (CH)
ORCID: Ridker, Paul M
Goldhaber, Samuel Z.
Rosenberg, Yves
Cushman, Mary
Moll, Stephan
Kessler, Craig M.
Elliott, C. Gregory
Bauer, Kenneth A.
Bounameaux, Henri
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2003-04-10
Volume: 348
Issue: 15
Pages: 1425-1434
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa035029
OpenAlex: W2112757583
Cited by: 808
References: 29
Citations by year: 2026: 3 · 2025: 9 · 2024: 5 · 2023: 7 · 2022: 10 · 2021: 13 · 2020: 16 · 2019: 23 · 2018: 16 · 2017: 19 · 2016: 25 · 2015: 24 · 2014: 45 · 2013: 38 · 2012: 44
FWCI: 53.42
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
Keywords: recurrent venous thromboembolism, long-term anticoagulation, idiopathic venous thromboembolism, major bleeding, inherited thrombophilia, international normalized ratio, benefit-risk balance
MeSH terms: Aged, Anticoagulants, Double-Blind Method, Drug Administration Schedule, Female, Hemorrhage, Humans, Male, Middle Aged, Pulmonary Embolism, Risk, Thromboembolism, Warfarin, International Normalized Ratio, Venous Thrombosis, Stroke, Secondary Prevention

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