SURGICAL REVASCULARIZATION VERSUS THROMBOLYSIS FOR NONEMBOLIC LOWER-EXTREMITY NATIVE ARTERY OCCLUSIONS - RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL

Purpose: Early results of a prospective study that compared surgical r evascularization and thrombolysis for lower extremity arterial and gra ft occlusions have been published. This report details the final resul ts in patients who have native artery occlusions. Methods: Two hundred thirty-seven patients who had lower extremity ischemia as a result of iliac-common femoral (IF; 69 patients) or superficial femoral-poplite al (PT; 168 patients) occlusion, and had symptomatically deteriorated within the past 6 months were randomized to catheter-directed thrombol ysis (150 patients) or surgical revascularization (87 patients). After diagnostic arteriographic examination but before randomization, the o ptimal surgical procedure was determined. Lytic patients were randomiz ed to recombinant tissue plasminogen activator (rt-PA; 84 patients) or urokinase (UR; 66 patients). Recurrent ischemia, morbidity, amputatio n, and death rates were determined at 30 days, 6 months, and 1 year, a nd were analyzed on an intent-to-treat basis. Results: For patients ra ndomized to lysis, a catheter was properly positioned and the lytic ag ent delivered in 78%. This provided a reduction in the predetermined s urgical procedure in 58% of patients who had an PT occlusion and 51% o f those who had an IP occlusion. rt-PA and UK were equally effective a nd safe, but lysis time was shorter with rt-PA (8 vs 24 hr; p < 0.05). At 1 year, the incidence of recurrent ischemia (64% vs 35%; p < 0.000 1) and major amputation (10% vs 0%; p = 0.0024) was increased in patie nts who were randomized to lysis. Factors associated with a poor lytic outcome included FT occlusion, diabetes, and critical ischemia. No di fferences in mortality rates were observed at 1 year between the lysis and surgical groups. Conclusion: Surgical revascularization for lower extremity native artery occlusions is more effective and durable than thrombolysis. Thrombolysis used initially provides a reduction in the surgical procedure for a majority of patients; however, long-term out come is inferior, particularly for patients who have an FP occlusion, diabetes, or critical ischemia.