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Previous Volume 348:1425-1434 April 10, 2003 Number 15 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Schafer, A. I. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

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.

Source Information

From the Center for Cardiovascular Disease Prevention and the Divisions of Preventive Medicine and Cardiology, Brigham and Women's Hospital and Harvard Medical School, Boston (P.MR., S.Z.G., E.D., R.J.G.); the National Institutes of Health, Bethesda, Md. (Y.R.); Washington University, St. Louis (C.S.E., J.P.M.); the Cleveland Clinic Foundation, Cleveland (S.R.D.); the University of Vermont, Burlington (M.C.); the University of North Carolina, Chapel Hill (S.M.); Georgetown University Medical Center, Washington, D.C. (C.M.K.); LDS Hospital, Salt Lake City (C.G.E.); Altru Research Clinic, Grand Forks, N.D. (R.P.); St. Boniface General Hospital, Winnipeg, Man., Canada (T.W.); Beth Israel Deaconess Medical Center, Boston (K.A.B.); Midwest Pulmonary Consultants, Kansas City, Mo. (B.A.S.); and the University Hospitals of Geneva, Geneva (H.B.).

This article was published at www.nejm.org on February 24, 2003.

Address reprint requests to Dr. Ridker at the Center for Cardiovascular Disease Prevention, Brigham and Women's Hospital, 900 Commonwealth Ave. E., Boston, MA 02215, or at pridker{at}partners.org.

Full Text of this Article

Related Letters:

Low-Intensity Warfarin Therapy for the Prevention of Recurrent Venous Thromboembolism
van Dongen C. J.J., Prins M. H., Büller H. R., Seneviratne C., Kupfer Y., Tessler S., Krishnan J. A., Streiff M. B., Cosmi B., Palareti G., Aberegg S. K., Ridker P. M., Goldhaber S. Z., Glynn R. J., the PREVENT Investigators
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N Engl J Med 2003; 349:398-400, Jul 24, 2003. Correspondence

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