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Volume 340:901-907 March 25, 1999 Number 12 Next

	Full Text PDF Editorial by Schafer, A. I. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited Related Article PubMed Citation

ABSTRACT

Background Patients who have a first episode of venous thromboembolism in the absence of known risk factors for thrombosis (idiopathic thrombosis) are often treated with anticoagulant therapy for three months. Such patients may benefit from longer treatment, however, because they appear to have an increased risk of recurrence after anticoagulant therapy is stopped.

Methods In this double-blind study, we randomly assigned patients who had completed 3 months of anticoagulant therapy for a first episode of idiopathic venous thromboembolism to continue receiving warfarin, with the dose adjusted to achieve an international normalized ratio of 2.0 to 3.0, or to receive placebo for a further 24 months. Our goal was to determine the effects of extended anticoagulant therapy on rates of recurrent symptomatic venous thromboembolism and bleeding.

Results A prespecified interim analysis of efficacy led to the early termination of the trial after 162 patients had been enrolled and followed for an average of 10 months. Of 83 patients assigned to continue to receive placebo, 17 had a recurrent episode of venous thromboembolism (27.4 percent per patient-year), as compared with 1 of 79 patients assigned to receive warfarin (1.3 percent per patient-year, P<0.001). Warfarin resulted in a 95 percent reduction in the risk of recurrent venous thromboembolism (95 percent confidence interval, 63 to 99 percent). Three patients assigned to the warfarin group had nonfatal major bleeding (two had gastrointestinal bleeding and one genitourinary bleeding), as compared with none of those assigned to the placebo group (3.8 percent vs. 0 percent per patient-year, P=0.09).

Conclusions Patients with a first episode of idiopathic venous thromboembolism should be treated with anticoagulant agents for longer than three months.

Source Information

From McMaster University, Hamilton, Ont., Canada (C.K., M.G., J.H., J.W., A.G.T., J.S.G., B.M., J.A.J.); Hamilton Civic Hospitals Research Centre, Hamilton, Ont., Canada (C.K., M.G., J.H., A.G.T., J.S.G., B.M.); the University of Western Ontario, London, Ont., Canada (M.J.K.); Dalhousie University, Halifax, N.S., Canada (D.R.A.); Northwestern University Medical School, Chicago (D.G.); and the University of Ottawa, Ottawa, Ont., Canada (P.W.). Other authors were Marilyn Johnston, A.R.T., Hamilton Civic Hospitals Research Centre, Hamilton, Ont.; James Douketis, M.D., and Robin Roberts, M.Tech., McMaster University, Hamilton, Ont.; Paul van Nguyen, M.D., and Jeannine Kassis, M.D., University of Montreal, Montreal; Sean Dolan, M.D., University of New Brunswick, St. John, N.B.; Christine Demers, M.D., and Louis Desjardins, M.D., Laval University, Quebec, Que.; Susan Solymoss, M.D., McGill University, Montreal — all in Canada; and Arthur Trowbridge, M.D., Texas A&M University, Temple.The institutions that participated in the study are listed in the Appendix.

Address reprint requests to Dr. Kearon at the Hamilton Health Sciences Corporation, Henderson Division, 711 Concession St., Hamilton, ON L8V 1C3, Canada.

Full Text of this Article

Related Letters:

Anticoagulation for Venous Thromboembolism
Bucciarelli P., Alatri A., Moia M., Khamashta M. A., Williams F. M.K., Hunt B. J., Kearon C., Ginsberg J. S., Gent M.
Extract | Full Text  
N Engl J Med 1999; 341:539-540, Aug 12, 1999. Correspondence

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