Results of the PHLEFI Study (PHLEbothrombosis-FIbrinolytic therapy): A prospective, multicenter study of the fate of 1498 patients receiving fibrinolytic therapy for deep vein thrombosis

Abstract

Fibrinolytic therapy for DVT has not gained universal acceptance. A notable percentage of DVTs in Germany are treated by clot-dissolving methods. This is in contrast to clinical practice in the United States where fibrinolytic treatment for DVT is virtually unknown. It is unique in modern medicine that such a frequent disease is treated so differently on a national basis. The PHLEFI Study is a multicenter, prospective trial on the fate of 1498 patients receiving different forms of fibrinolytic therapy for DVT (ultrahigh streptokinase and urokinase short-term therapy, streptokinase, urokinase, and rt-PA long-term infusions, locoregional and sequential therapies). Interest focused primarily on side-effects such as cerebral bleeding and fatal pulmonary embolism as well as on the clinical outcome in terms of revascularization. The major factor for the rate of cerebral bleeding under fibrinolytic therapy was the age of the patient (0.355% bleeding in patients under and 2.03% in patients over 50 years). The major factor for pulmonary embolism was the site of the thrombosis (2.16% with iliac, 0.701% with femoral, none with popliteal, calf and subclavian vein thromboses). Use of a temporary caval filter during lysis therapy eliminated fatal pulmonary embolism. Results of lytic therapy were stated as complete, partial, and no clearance. The outcome was dependent on the thrombus age and the medication used. The highest clearance rate achieved was 50% in patients treated with short-term ultrahigh streptokinase therapy and a history of up to three days. Fibrinolytic therapy for DVT is a reliable means of achieving revascularization. The above data may enable the physician to balance the usefulness of this therapeutic method against the risk of its side effects.