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Clinical Impact of Bleeding in Patients Taking Oral Anticoagulant Therapy for Venous Thromboembolism: A Meta-Analysis

Lori-Ann Linkins, MD, FRCP(C); Peter T. Choi, MD, MSc, FRCP(C); and James D. Douketis, MD, FRCP(C)
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From McMaster University, Hamilton, Ontario, Canada; and University of British Columbia, Vancouver, British Columbia, Canada.

Acknowledgments: The authors thank Drs. Clive Kearon, Mark Crowther, Lehana Thabane, and Jack Hirsh for their helpful reviews of the manuscript.

Grant Support: Dr. Linkins is the recipient of a Fellowship Award from the Heart & Stroke Scientific Research Corporation of Canada/AstraZeneca Canada, Inc. Dr. Douketis is a recipient of a Research Scholarship from the Heart and Stroke Foundation of Canada.

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: James D. Douketis, MD, FRCP(C), St. Joseph's Healthcare, Room F-541, 50 Charlton Avenue East, Hamilton, Ontario L8N 4A6, Canada; e-mail, jdouket@mcmaster.ca.

Current Author Addresses: Dr. Linkins: Henderson Research Centre, Room 220, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.

Dr. Choi: Department of Anesthesia, University of British Columbia, 2329 West Mall, Vancouver V6T 1Z4, British Columbia.

Dr. Douketis: St. Joseph's Healthcare, Room F-541, 50 Charlton Avenue East, Hamilton, Ontario L8N 4A6, Canada.

Author Contributions: Conception and design: L.A. Linkins, J.D. Douketis.

Analysis and interpretation of the data: L.A. Linkins, P.T. Choi, J.D. Douketis.

Drafting of the article: L.A. Linkins, J.D. Douketis.

Critical revision of the article for important intellectual content: L.A. Linkins, P.T. Choi, J.D. Douketis.

Final approval of the article: L.A. Linkins, P.T. Choi, J.D. Douketis.

Statistical expertise: P.T. Choi.

Administrative, technical, or logistic support: J.D. Douketis.

Collection and assembly of data: L.A. Linkins.

Ann Intern Med. 2003;139(11):893-900. doi:10.7326/0003-4819-139-11-200312020-00007
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To our knowledge, this is the first study to determine the clinical impact of anticoagulant-related bleeding in patients with venous thromboembolism who are receiving oral anticoagulant therapy. Overall, the case-fatality rate of major bleeding was 13.4% and the risk for intracranial bleeding was 1.1 per 100 patient-years. Thus, the clinical impact of anticoagulant-related major bleeding is considerable—about 1 in 7 bleeding episodes are fatal or intracranial—and may be greater than previously perceived. After the initial 3 months of anticoagulant therapy, the case-fatality rate of major bleeding was 9.1% and the risk for intracranial bleeding was 0.65 per 100 patient-years in patients who received extended-duration anticoagulation. These findings are likely to be valid because the source data for our pooled analyses were derived from well-designed clinical trials in which major bleeding and death were primary study outcomes. Consequently, these outcomes were probably documented reliably.

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Summary for Patients

Consequences of Serious Bleeding Complications from Warfarin

The summary below is from the full report titled “Clinical Impact of Bleeding in Patients Taking Oral Anticoagulant Therapy for Venous Thromboembolism. A Meta-Analysis.” It is in the 2 December 2003 issue of Annals of Internal Medicine (volume 139, pages 893-900). The authors are L.A. Linkins, P.T. Choi, and J.D. Douketis.


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