Cerebral intraarterial fibrinolysis at the crossroads : is a phase III trial advisable at this time ? Commentary

PURPOSE: To describe the rationale for fibrinolysis, review the state of the art in cerebral fibrinolysis, and discuss whether it is time for phase 111 studies of cerebral intraarterial fibrinolysis. METHODS: Critical review of the literature with statistical reevaluation of significant clinical data. RESULTS: There are abundant phase 111 data supporting the use of thrombolysis in the cardiovascular system. However, there are no published phase 111 trials of intraarterial fibrinolysis in stroke. All reports of cerebral intraarterial fibrinolysis are case series. The studies are typically small with variable treatment protocols and designs that are susceptible to bias. The only analysis comparing cerebral intraarterial fibrinolysis with conventional therapy is based on nonconcurrent controls