Risk of major bleeding in unselected patients with venous thromboembolism.

PURPOSE: To evaluate the risk of major bleeding in unselected patients given anticoagulant treatment (heparin overlapped and followed by oral anticoagulants) because of deep vein thrombosis (DVT) or pulmonary embolism (PE). SUBJECTS AND METHODS: We screened the database of 1590 outpatients suspected of DVT and PE in prospective diagnostic studies conducted in Geneva between 1992 and 1998. RESULTS: Four hundred and eleven of 1590 patients (26%) were anticoagulated for confirmed venous thromboembolism (PE, 300; DVT, 111). One patient was excluded because of concomitant thrombolytic therapy. Five (1.2%; 95% confidence interval, 0.4-2.8) of the remaining 410 patients experienced a major hemorrhagic event during the 3-month follow-up, including two fatal events. All bleedings occurred during the first month of therapy (heparin, two; oral anticoagulants, two; combined treatment, one) and the median age of the patients who bled was 80 years. At least one serious comorbid condition associated with higher bleeding risk was present in four patients and, in one case, the bleeding was clearly related to an excessive intensity of anticoagulation. CONCLUSION: The rate of bleeding events in this population of unselected outpatients is similar to that reported in controlled therapeutic trials. The hemorrhagic events occurred early in the course of anticoagulant therapy and concerned old patients mostly affected by at least one comorbid condition. Particular care should be used to avoid the risk of overtreatment.