Different Doses of Recombinant Tissue-Type Plasminogen Activator for Acute Stroke in Chinese Patients

Background and Purpose-The relationship between the dose of recombinant tissue-type plasminogen activator (r-tPA) and its safety/efficacy for ischemic stroke has not been well evaluated in the East Asian population. We assessed the safety/efficacy of different doses of r-tPA for acute ischemic stroke in Chinese patients. Methods-A total of 1004 eligible patients were classified according to the dose of r-tPA received for managing acute ischemic stroke: 0.9 mg/kg (n= 422), 0.8 mg/kg (n= 202), 0.7 mg/kg (n= 199), and 0.6 mg/kg (n= 181). The safety outcome was symptomatic intracerebral hemorrhage and death within 3 months. The efficacy outcome was good functional outcome (modified Rankin Scale <= 1) at 3 months. Results-There was a significant trend for symptomatic intracerebral hemorrhage with age (P= 0.002). With multivariate logistic regression analysis, a dose of 0.9 mg/kg was a predictor of symptomatic intracerebral hemorrhage (P= 0.0109), and a dose <= 0.65 mg/kg was a predictor of good functional outcome (P= 0.0369). In patients aged 71 to 80 years, there was a significant trend of increasing symptomatic intracerebral hemorrhage (P= 0.0130) and less good functional outcome (P= 0.0179) with increasing doses of r-tPA. There was also a trend of increasing mortality (P= 0.0971) at 3 months in these patients. Conclusions-These results did not support the dose of 0.9 mg/kg of r-tPA being optimal for all patients in the East Asian population. In elderly patients (71-80 years), a lower dose of 0.6 mg/kg is associated with a better outcome. Confirmation of the results through randomized trial is required.