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QUESTION: In patients with proximal deep venous thrombosis (PDVT) or pulmonary embolism, or both, or isolated calf deep venous thrombosis (CDVT), is long term treatment better than short term treatment with oral anticoagulants for preventing recurrences and bleeding complications?
Randomised (allocation concealed*), unblinded,* controlled trial with 15 months of follow up.
736 patients (mean age 59 y, 53% women) who had symptomatic PDVT or pulmonary embolism, or both, or symptomatic CDVT confirmed by objective diagnostic tests. Exclusion criteria included pregnancy, breast feeding, vena cava filter implantation, surgical thrombectomy, free-floating thrombus in the inferior vena cava, active cancer or malignant haematological disease, or a previous venous thromboembolism. 97% of patients completed the study.
375 patients (270 with PDVT or pulmonary embolism, or both, and 105 with CDVT) were allocated to short term (3 mo for PDVT–pulmonary embolism, 6 wk for CDVT) oral anticoagulant treatment, and 361 patients (269 with PDVT or pulmonary embolism, or both, and 92 with CDVT) were allocated to long term (6 mo for PDVT–pulmonary embolism, 12 wk for CDVT) treatment with oral anticoagulants. Fluindione was used for oral anticoagulation with dose adjustments to …
Sources of funding: French Ministry of Health; Hospices Civils de Lyon; Conseil Régional Rhône-Alpes; Association pour la recherché et l'évaluation thérapeutique (APRET).
For correspondence: Dr L Pinede, Department of Internal Medicine, Edouard Herriot Hospital, 69437 Lyons Cedex 03, France. Fax +33 4721 17567.