Results of the prospective randomized trials for surgery versus catheter-directed thrombolysis of lower extremity arterial disease

Abstract

The 1990s have witnessed the performance of several prospective, randomized trials-studies that provide a wealth of information on which to base clinical decisions. The Rochester trial randomized patients with very severe acute occlusions to immediate surgery or urokinase (UK) and documented survival benefits in the thrombolytic group. The Surgery or Thrombolysis for the Ischemic Lower Extremity trial studied patients with occlusions up to 6 months in duration, randomized into 3 groups, UK, recombinant tissue plasminogen activator, and surgery. Although a significant difference was detected in the rate of ongoing and recurrent ischemia in favor of the surgical group, a post hoc analysis identified improved limb salvage in acute occlusions treated with thrombolysis. The most recent trial, the study of Thrombolysis or Peripheral Arterial Surgery, randomized patients with acute lower extremity occlusions to a recombinant form of UK or primary operation. Although no differences were detected with respect to survival or limb salvage, patients with thrombolysis required significantly fewer and less invasive interventions than the surgical patients to achieve these results. In summary, the observations of these three prospective trials suggest that thrombolysis may offer benefits to patients with acute peripheral arterial occlusions. Thrombolytic therapy should be considered in the setting of acute limb ischemia as a safe and effective treatment modality in this complex, medically fragile group of patients.