STROKE AFTER THROMBOLYSIS - MORTALITY AND FUNCTIONAL OUTCOMES IN THE GUSTO-I TRIAL

Background Stroke is the most feared complication of thrombolysis for acute myocardial infarction because of the resulting mortality and dis ability. We analyzed the incidence, timing, and outcomes of stroke in an international trial. Methods and Results Patients were randomly ass igned to one of four thrombolytic strategies. Neurological events were confirmed clinically and anatomically and were adjudicated by a blind ed committee. Stroke survivors, categorized by residual deficit and di sability, assessed their quality of life with a time trade-off techniq ue. Multivariable regression identified patient characteristics associ ated with intracranial hemorrhage. Overall, 1.4% of the patients had a stroke (93% anatomic documentation). The risk ranged from 1.19% with streptokinase/subcutaneous heparin therapy to 1.64% with combination t hrombolytic therapy (P=.007). Primary intracranial hemorrhage rates ra nged from 0.46% with streptokinase/subcutaneous heparin to 0.88% with combination therapy (P<.001). Of all strokes, 41% were fatal, 31% were disabling, and 24% were nondisabling, with no significant treatment-r elated differences. Stroke subtype affected prognosis: 60% of patients with primary intracranial hemorrhage died and 25% were disabled versu s 17% dead and 40% disabled with nonhemorrhagic infarctions. Patients with moderate or severe residual deficits showed significantly decreas ed quality of life. Advanced age, lower weight, prior cerebrovascular disease or hypertension, systolic and diastolic blood pressures, rando mization to tissue plasminogen activator, and an interaction between a ge and hypertension were significant predictors of intracranial hemorr hage. Conclusions Stroke remains a rare but catastrophic complication of thrombolysis. Additional studies should assess the net clinical ben efit of thrombolysis in high-risk subgroups, particularly the elderly and patients with prior cerebrovascular events.