Catheter-directed thrombolysis in deep venous thrombosis with use of reteplase: immediate results and complications from a pilot study.

PURPOSE: To prospectively determine the thrombolytic success and complication rates of catheter-directed thrombolytic infusions in deep vein thrombosis (DVT) with use of reteplase.

MATERIALS AND METHODS: After approval by the institutional review board, prospective, detailed data were obtained for 25 consecutive patients with acute and chronic DVT of the upper or lower extremity (seven upper extremity; 14 lower extremity; four vena cava). Infusion rates were 1.0 U/h in five patients and 0.5 U/h in the remaining 20. Subtherapeutic heparin doses of 300-400 U/h were administered. Thrombolytic success was defined as 95% thrombolysis with return of antegrade flow. Data, including complications such as bleeding, need for transfusions, and laboratory values (fibrinogen, platelets, hematocrit, hemoglobin, and prothrombin time) were obtained throughout the infusions.

RESULTS: The total dose of reteplase administered ranged from 2.5 to 42 U (median, 16.5 U). The total infusion time ranged from 0.3 to 84 hours (median, 29 h). Thrombolytic success was achieved in 92% of patients. Endovascular stent placement and/or percutaneous transluminal angioplasty were required in 52% of patients to ensure maintenance of patency. Pre- and postprocedural average fibrinogen levels were 340 mg/dL and 315.3 mg/dL, respectively. The lowest mean fibrinogen levels for the two dose groups were 265.86 mg/dL for the 0.5 U/h group and 314.18 mg/dL for the 1.0 U/h group. The lowest fibrinogen level during the procedure was 252.3 mg/dL (range, 35 to >700). There were only two instances of fibrinogen levels that decreased to below 90 mg/dL: 35 mg/dL and 43 mg/dL. Thrombolytic failures occurred in two patients: one with acquired immune deficiency syndrome in a hypercoagulable state and one with a major bleeding complication. This was the only patient with a bleeding complication (4%). Hemorrhage occurred from the site of a previous mediastinal biopsy-which should have rendered her ineligible for the study-performed 18 hours before the thrombolysis. If thrombolysis had not been attempted in this patient, the complication rate would have been 0%.

CONCLUSION: Although there are reports of thrombolytic therapy in peripheral vascular occlusive disease, this study is one of the first to evaluate thrombolytic drugs in the deep venous system exclusively. Reteplase was found to be effective in the thrombolytic treatment of acute and chronic DVT.