Femoro-popliteal artery thrombolysis with intra-arterial infusion of recombinant tissue-type plasminogen activator--report of a pilot trial.

Recombinant tissue-type plasminogen activator (rt-PA) was infused at a rate of 10 mg/h into 50 thrombosed femoral and popliteal arteries. Patency was restored in 43 but a secondary angioplasty led to 2 reocclusions and in 3 patients early rethrombosis occurred. A favourable clinical result was thus obtained in 38 patients (76%). Thirteen bleeding complications occurred in 10 patients, mainly haematomas at puncture sites. One patient required blood transfusion for gastro-intestinal bleeding from a previously unknown ulcer. The angiographic recanalisation rate in 16 patients who received a slower infusion of rt-PA (5 or 3 mg/h) was 94% and the clinical success rate in this series was 81%. However, the incidence of bleeding complications was not decreased by the slower infusion rate. The data obtained confirm the feasibility of rt-PA thrombolysis in peripheral arterial thrombosis and warrant a comparative study with streptokinase.