FEMORO-POPLITEAL ARTERY THROMBOLYSIS WITH INTRA-ARTERIAL INFUSION OF RECOMBINANT TISSUE-TYPE PLASMINOGEN ACTIVATOR (rt-PA)

The efficacy and tolerance of intra-arterial rt-PA infusion was tested in 27 patients with a thrombotic occlusion of the femoro-popliteal artery. The mean length of the occluding thrombus was 10 cm (range : 2-25 cm). The occlusion was recent (<1 week old) in 7 patients; in 2 it existed for more than 6 months. The rt-PA solution was infused through an angiographic catheter embedded into the thrombus at a rate of 10 mg/hr in the first 11 patients, 5 mg/hr in the next 11 and 3 mg/hr in the last 5. The maximal dose foreseen in the protocol was 50 mg; the mean dose infused was 42 mg. Heparin (400 IU/hr) was infused concomitantly. Thrombolysis occurred in all 27 patients. Angiographic restoration of patency was obtained in 25 (93%); it first appeared after a mean dose of 27 mg rt-PA (range : 10 to 50 mg). In 21 patients, a percutaneous transluminal angioplasty was needed to dilate a residual stenotic lesion or remaining mural thrombi. This secondary procedure initiated reocclusion in 2 patients by causing a distal embolus and a subintimal dissection, respectively. Early rethrombosis occurred spontaneously in 3 other patients. Thus, 20 (74%) patients had a clinical improvement at discharge from the hospital.

rt-PA infusion was complicated by bleeding in 10 (37%) patients: a groin hematoma at the catheter entry site occurred in 9 patients, a hematoma from a previous venous in 2 and gingival oozing in 3. None required blood transfusion. Premature interruption of the infusion because of local hematoma formation was the cause of failure in one patient.

This pilot trial confirms the feasibility of thrombolysis with local infusion of rt-PA in peripheral arterial thrombosis. The early clinical results and the incidence of bleeding complications appear similar to those observed with local low-dose streptokinase, although initial patency seems easier to restore with rt-PA. A prospective trial comparing rt-PA to streptokinase in this condition is thus warranted