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.