RESULTS OF A PROSPECTIVE, RANDOMIZED TRIAL OF SURGERY VERSUS THROMBOLYSIS FOR OCCLUDED LOWER-EXTREMITY BYPASS GRAFTS

PURPOSE: The purpose of this study was to prospectively evaluate the t reatment of patients with occluded lower extremity bypass grafts, comp aring surgical revascularization with catheter-directed thrombolysis. MATERIALS AND METHODS: One hundred twenty-four patients (68% male and 32% female) with lower limb bypass graft occlusion (46 autogenous and 78 prosthetic) were prospectively randomized to surgery (n = 46) or in tra-arterial catheter-directed thrombolysis (n = 78) with recombinant tissue plasminogen activator (rt-PA) 0.1 mg/kg/h modified to 0.05 mg/k g/h for up to 12 hours, or urokinase (UK) 250,000 U bolus followed by 4,000 U/min for 4 hours, then 2,000 U/min for up to 36 hours, A compos ite clinical outcome including death, amputation, ongoing/recurrent is chemia, and major morbidity was analyzed on an intent-to-treat basis a t 30 days and 1 year. RESULTS: The average duration of graft occlusion was 34.0 days, with 58 (48%) presenting with acute ischemia (0 to 14 days) and 64 (52%) with chronic ischemia (>14 days). Thirty-nine perce nt randomized to lysis failed catheter placement and required surgical revascularization. Overall, there was a better composite clinical out come at 30 days (P = 0.023) and 1 year (P = 0.04) in the surgical grou p compared with lysis, due predominately to a reduction in ongoing/rec urrent ischemia, most notable in autogenous grafts, However, following successful catheter placement, patency was restored by lysis in 84%, and 42% had a major reduction in their planned operation. One-year res ults of successful lysis compared favorably with the best surgical pro cedure, which was new graft placement. Acutely ischemic patients (0 to 14 days) randomized to lysis demonstrated a trend toward a lower majo r amputation rate at 30 days (P = 0.074) and significantly at 1 year ( P = 0.026) compared with surgical patients, while those with >14 days ischemia showed no difference in limb salvage but higher ongoing/recur rent ischemia in lytic patients (P < 0.001), Patients with occluded pr osthetic grafts had greater major morbidity than did those with occlud ed autogenous grafts (P < 0.02). CONCLUSIONS: Proper catheter position ing currently limits the potential of catheter-directed thrombolysis f or lower extremity bypass graft occlusion, Patients with graft occlusi on >14 days have a significantly better outcome when treated surgicall y, with a new bypass being the best surgical option. However, in patie nts with acute limb ischemia ((14 days) successful thrombolysis of occ luded lower extremity bypass grafts improves limb salvage and reduces the magnitude of the planned surgical procedure. Patients with occlude d prosthetic grafts suffer more major morbid events compared with occl uded autogenous grafts.