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Blood, 1 December 2008, Vol. 112, No. 12, pp. 4432-4436.
Prepublished online as a Blood First Edition Paper on September 12, 2008; DOI 10.1182/blood-2008-06-163279.
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Submitted June 16, 2008
Accepted August 8, 2008
Influence of thrombophilia on risk of recurrent venous thromboembolism while on warfarin: Results from a randomized trial
Clive Kearon*, Jim A. Julian, Michael J. Kovacs, David R. Anderson, Philip Wells, Betsy MacKinnon, Jeffrey I. Weitz, Mark A. Crowther, Sean Dolan, Alexander G. Turpie, William Geerts, Susan Solymoss, Paul van Nguyen, Christine Demers, Susan R. Kahn, Jeannine Kassis, Marc Rodger, Julie Hambleton, Michael Gent, and Jeffrey S. Ginsberg
McMaster University, Hamilton, Ontario, Canada
Henderson Research Centre, Hamilton, Ontario, Canada
University of Western Ontario, London, Ontario, Canada
Dalhousie University, Halifax, Nova Scotia, Canada
Clinical Epidemiology Program, Ottawa Health Research Institute, University of Ottawa, Ottawa, Ontario, Canada
University of New Brunswick, St. John, New Brunswick, Canada
University of Toronto, Toronto, Ontario, Canada
McGill University, Montreal, Quebec, Canada
University of Montreal, Montreal, Quebec, Canada
Laval University, Quebec City, Quebec, Canada
University of California, San Francisco, CA, United States
* Corresponding author; email: kearonc{at}mcmaster.ca.
We sought to determine if thrombophilic defects increase recurrent VTE during warfarin therapy. 661 patients with unprovoked VTE who were randomized to extended low-intensity (INR of 1.5-1.9) or conventional-intensity (INR 2.0-3.0) anticoagulant therapy were tested for thrombophilia and followed for a mean of 2.3 years. One or more thrombophilic defects were present in 42% of patients. The overall rate of recurrent VTE was 0.9% per patient-year. Recurrent VTE was not increased in the presence of factor V Leiden (hazard ratio [HR] 0.7; 95%CI 0.2 to 2.6); the G20210A prothrombin gene mutation (HR 0); antithrombin deficiency (HR 0); elevated factor VIII (HR 0.7; 95%CI 0.1 to 5.4); elevated factor XI (HR 0.7; 95%CI 0.1 to 5.0) or elevated homocysteine (HR 0.7; 95%CI 0.1 to 5.3); but showed a trend to an increase with an antiphospholipid antibody (HR 2.9; 95%CI 0.8 to 10.5). Compared to patients with no thrombophilic defects, the rate of recurrence was not increased in the presence of one (HR 0.7; 95%CI 0.2 to 2.3) or more than one (HR 0.7; 95%CI 0.2 to 3.4) defect. We conclude that single or multiple thrombophilic defects are not associated with a higher risk of recurrent VTE during warfarin therapy.
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