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Volume 336:393-398 February 6, 1997 Number 6 Next

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ABSTRACT

Background A consensus has not been reached about the optimal duration of oral anticoagulant therapy after a second episode of venous thromboembolism.

Methods In a multicenter trial, we compared six months of oral anticoagulant therapy with anticoagulant therapy continued indefinitely in patients who had had a second episode of venous thromboembolism. Of 227 patients enrolled, 111 were randomly assigned to six months of anticoagulation and 116 were assigned to receive anticoagulant therapy indefinitely; for both groups, the target international normalized ratio was 2.0 to 2.85. The initial episodes of deep-vein thrombosis (n = 193) and pulmonary embolism (n = 34), as well as recurrent episodes, were all objectively confirmed.

Results After four years of follow-up, there were 26 recurrences of venous thromboembolism that fulfilled the diagnostic criteria, 23 in the group assigned to six months of therapy (20.7 percent) and 3 in the group assigned to continuing therapy (2.6 percent). The relative risk of recurrence in the group assigned to six months of therapy, as compared with the group assigned to therapy of indefinite duration, was 8.0 (95 percent confidence interval, 2.5 to 25.9). There were 13 major hemorrhages, 3 in the six-month group (2.7 percent) and 10 in the indefinite-treatment group (8.6 percent). The relative risk of major hemorrhage in the six-month group, as compared with the indefinite-treatment group, was 0.3 (95 percent confidence interval, 0.1 to 1.1). There was no difference in mortality between the two groups.

Conclusions Prophylactic oral anticoagulation that was continued for an indefinite period after a second episode of venous thromboembolism was associated with a much lower rate of recurrence during four years of follow-up than treatment for six months. However, there was a trend toward a higher risk of major hemorrhage when anticoagulation was continued indefinitely.

Source Information

From the Departments of Internal Medicine at Karolinska Hospital, Stockholm (S.S., P.L.), Huddinge Hospital, Huddinge (M.H.), Danderyd Hospital, Danderyd (A.C.), Köping Hospital, Köping (P.N.), Södertälje Hospital, Södertälje (S.-G.E.), Västerås Central Hospital, Västerås (S.N.), Södersjukhuset, Stockholm (G.L.), St. Göran Hospital, Stockholm (B.L.), Örebro Regional Hospital, Örebro (O.L.), and Nacka Hospital, Stockholm (E.L.); and the Department of Radiology, Ersta Hospital, Stockholm (S.G.) — all in Sweden. Other authors were Hans Walter, M.D., Sabbatsberg Hospital, Stockholm; Stanka Viering, M.D., Norrtälje Hospital, Norrtälje; Martin Hjorth, M.D., Lidköping Hospital, Lidköping; and Jonas Boberg, M.D., Uppsala Academic Hospital, Uppsala.

Address reprint requests to Dr. Schulman at the Department of Internal Medicine, Karolinska Hospital, S-171 76 Stockholm, Sweden.

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Venous Thromboembolism
Block J. A., White T. M., Fetrow C.W., Schulman S., The Duration of Anticoagulation Trial Study Group , Diuguid D. L.
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N Engl J Med 1997; 337:51-53, Jul 3, 1997. Correspondence

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