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(Circulation. 2001;103:2453.)
© 2001 American Heart Association, Inc.

Clinical Investigation and Reports

Comparison of 3 and 6 Months of Oral Anticoagulant Therapy After a First Episode of Proximal Deep Vein Thrombosis or Pulmonary Embolism and Comparison of 6 and 12 Weeks of Therapy After Isolated Calf Deep Vein Thrombosis

Laurent Pinede, MD, PhD; Jacques Ninet, MD; Pierre Duhaut, MD, PhD; Sylvie Chabaud, MSc; Sylvie Demolombe-Rague, MD; Isabelle Durieu, MD, PhD; Patrice Nony, MD, PhD; Christian Sanson, MD; Jean-Pierre Boissel, MD, PhD; for the Investigators of the "Durée Optimale du Traitement AntiVitamines K" (DOTAVK) Study¹

From the Department of Internal Medicine (L.P., J.N., P.D., S.D.-R., I.D.), the Clinical Pharmacology Unit (S.C., P.N., J.-P.B.), and the Pneumological Unit (C.S.), Centre Hospitalier Universitaire de Lyon, France.

Correspondence to Dr Laurent Pinède, Department of Internal Medicine, Edouard Herriot Hospital, 69437 Lyons Cedex 03, France. E-mail laurent.pinede{at}chu-lyon.fr

Background—The optimal duration of oral anticoagulant therapy after a first episode of venous thromboembolism remains controversial.

Methods and Results—We performed an open-label, randomized trial comparing a short oral anticoagulant course (3 months for proximal deep vein thrombosis [P-DVT] and/or pulmonary embolism [PE]; 6 weeks for isolated calf DVT [C-DVT]) with a long course of therapy (6 months for P-DVT/PE; 12 weeks for C-DVT). The outcome events were recurrences and major, minor, or fatal bleeding complications. A total of 736 patients were enrolled. There were 23 recurrences of venous thromboembolism in the short treatment group (6.4%) and 26 in the long treatment group (7.4%); the 2 treatment regimens had an equivalent effect. For the hemorrhage end point, the difference between the short and the long treatment groups was not significant: 15.5% versus 18.4% for all events (P=0.302), 1.7% versus 2.8% (P=0.291) for major events, and 13.9% versus 15.3% for minor bleeding. Subgroup analysis demonstrated that the rate of recurrence was lower for C-DVT than for P-DVT or PE.

Conclusions—After isolated C-DVT, 6 weeks of oral anticoagulation is sufficient. For P-DVT or PE, we demonstrated an equivalence between 3 and 6 months of anticoagulant therapy. For patients with temporary risk factors who have a low risk of recurrence, 3 months of treatment seems to be sufficient. For patients with idiopathic venous thromboembolism or permanent risk factors who have a high risk of recurrence, other trials are necessary to assess prolonged therapy beyond 6 months.

Key Words: venous thrombosis • pulmonary embolism • anticoagulants

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