Percutaneous transluminal angioplasty and enclosed thrombolysis versus percutaneous transluminal angioplasty in the treatment of femoropopliteal occlusions: Results of a prospective randomized trial

Purpose: To determine whether percutaneous transluminal angioplasty (PTA) and enclosed thrombolysis (ET) is superior to PTA alone in the treatment of femoropopliteal occlusions. Methods: Twenty-five patients with 5-15-cm-long occlusions in the femoropopliteal segments, with otherwise normal run-in arteries and at least one normal tibioperoneal artery to the foot, were randomized to ET/PTA or PTA alone. Ankle brachial systolic index (ABI) was measured before the procedure and at 24 hr and 12 months after the procedure, when a duplex scan was also carried out. End points in the study were patency at, or repeat intervention before, 12 months. Results: Procedures were successful in 23 of 25 patients. There was one immediate occlusion of tibioperoneal arteries, and one early reocclusion of a reopened segment in the ET/PTA group. There was one early reocclusion in the PTA group. At 12 months patency was 70% and 69.2% in the ET/PTA and PTA groups respectively. Covariant analysis showed no significant difference in ABI between the two groups at any of the three measurement times. Conclusion: This trial demonstrated no difference between ET/PTA and PTA alone in femoropopliteal occlusions associated with normal proximal arteries and at least one normal tibioperoneal artery.