Antithrombotic Therapy in Peripheral Arterial Occlusive Disease: Multicenter trial of thrombolysis
However, this latter finding stemmed from post hoc, subgroup analysis and cannot be considered definitive. There was no difference in efficacy or safety between tPA and urokinase. A randomized clinical trial comparing urokinase and recombinant tissue plasminogen activator (rtPA) noted a slight improvement in successful recanalization with rtPA in all infrainguinal segments treated (p < 0.05). A total of 120 patients at a single institution presenting with acute or subacute infrainguinal thrombotic occlusion were studied. At 6 months, the group treated with rtPA had improved claudication scores and a lower rate of limb amputation than the urokinase group, although these differences did not achieve statistical significance. Local hematomas were more common in the rtPA group, and there were no major bleeding complications in either group.
In a multicenter trial of thrombolysis or peripheral arterial surgery (TOPAS, level II), the role of thrombolytic therapy vs surgical intervention in the setting of acute arterial occlusion of the lower extremity was evaluated. This was a preliminary phase I trial designed to assess the dose ranging, safety, and efficacy of three doses of urokinase in comparison with surgery. In this randomized clinical trial, 213 patients were studied who had lower extremity ischemia for up to 14 days. No difference was observed in 1-year mortality or amputation-free survival in the urokinase-treated patients or those undergoing surgery. Open surgical procedures were avoided in 45.8% of patients randomized to urokinase. The TOPAS investigators recently published their follow-up study (level I), in which 548 patients were randomized to either thrombolytic therapy or surgery to treat acute lower-extremity ischemia within 14 days of onset. The primary end point of the study, amputation-free survival at 6 months, was the same for both groups (urokinase, 71.8%; surgery, 74.8%; p = 0.43). There was a significant increase in the rate of major hemorrhage in the urokinase group compared with the surgery group; and four patients treated with urokinase sustained intracranial hemorrhage, one of which was fatal. The only apparent benefit of urokinase was that fewer patients required open surgical procedures buy allegra online buy allegra online. At the end of 6 months, 31.5% of urokinase-treated patients had not required an open surgical procedure. In the absence of conventional evidence demonstrating benefit such as improved limb salvage, decreased mortality, or lower cost, thrombolysis for acute lower-extremity ischemia cannot be regarded as the standard of care for routine use in this clinical setting. It remains, however, a reasonable therapeutic option for selected patients in whom the risks of emergency surgical therapy are determined to outweigh the risks of thrombolysis.