Safety of thrombolytic therapy with urokinase or recombinant tissue plasminogen activator for peripheral arterial occlusion: a comprehensive compilation of published work.

PURPOSE: To report a comprehensive literature review focused on comparing the risk of complications with urokinase versus recombinant tissue plasminogen activator (rtPA) for thrombolytic treatment of peripheral arterial occlusions.
METHODS: The English-language literature between 1985 and 2002 was searched for studies that used tissue-derived urokinase or rtPA in the treatment of peripheral arterial occlusions. Forty-eight studies (22 urokinase, 22 rtPA, and 4 that included both treatments) were identified, encompassing 2226 urokinase-treated patients and 1927 rtPA-treated patients. The safety of each thrombolytic agent was assessed based on the incidence of major hemorrhage, intracerebral hemorrhage, major limb amputation, transfusions, and mortality.
RESULTS: The review revealed a wide range of study protocols, patient conditions, ages of occlusions, dosages/delivery methods of lytic agents, and criteria for reporting complications. The incidence of major hemorrhage varied widely, but the overall rate was lower among urokinase-treated patients (6.2%) than for patients treated with rtPA (8.4%, p=0.007). The overall incidence of intracerebral hemorrhage was also significantly lower for urokinase (0.4% versus 1.1% for rtPA, p=0.020). The major amputation rate was similar for both treatments (urokinase 7.9%, rtPA 7.2%), but the mortality rate was significantly lower for urokinase (3.0% versus 5.6% for rtPA, p<0.001). The need for transfusions was less frequent with urokinase (11.1% versus 16.1%, p=0.002).
CONCLUSIONS: These results from a large body of published literature suggest that urokinase may be associated with a lower incidence of complications than rtPA in the treatment of peripheral arterial occlusions.