A COMPARISON OF THROMBOLYTIC THERAPY WITH OPERATIVE REVASCULARIZATIONIN THE INITIAL TREATMENT OF ACUTE PERIPHERAL ARTERIAL ISCHEMIA

Purpose: Despite the widespread use of intraarterial thrombolytic ther apy for peripheral arterial occlusive disease, a randomized study comp aring its efficacy with that of operative intervention has never been performed. This study evaluates the potential of intraarterial urokina se infusion to provide clinical benefits in patients with acute periph eral arterial occlusion. Methods: Patients with limb-threatening ische mia of less than 7 days' duration were randomly assigned to intraarter ial catheter-directed urokinase therapy or operative intervention. Ana tomic lesions unmasked by thrombolysis were treated with balloon dilat ion or operation. The primary end points of the study were limb salvag e and survival. Results: A total of 57 patients were randomized to the thrombolytic therapy group, and 57 patients were randomized to the op erative therapy group. Thrombolytic therapy resulted in dissolution of the occluding thrombus in 40 (70%) patients. Although the cumulative limb salvage rate was similar in the two treatment groups (82% at 12 m onths), the cumulative survival rate was significantly improved in pat ients randomized to the thrombolysis group (84% vs 58% at 12 months, p = 0.01). The mortality differences seemed to be primarily attributabl e to an increased frequency of in-hospital cardiopulmonary complicatio ns in the operative treatment group (49% vs 16%, p = 0.001). The benef its of thrombolysis were achieved without significant differences in t he duration of hospitalization (median 11 days) and with only modest i ncreases in hospital cost in the thrombolytic treatment arm (median $1 5,672 vs $12,253, p = 0.02). Conclusions: Intraarterial thrombolytic t herapy was associated with a reduction in the incidence of in-hospital cardiopulmonary complications and a corresponding increase in patient survival rates. These benefits were achieved without an appreciable i ncrease in the duration of hospitalization and with only modest increa ses in hospital cost, suggesting that thrombolytic therapy may offer a safe and effective alternative to operation in the initial treatment of patients diagnosed with acute limb-threatening peripheral arterial occlusion.