Abstract T P55: The Safety and Efficacy of Alteplase for Acute Ischaemic Stroke in Chinese Patients

Abstract

Background: The relationship between the dose of alteplase and its safety/efficacy for ischaemic stroke has not been well evaluated in the Asian population. In the present study, we assessed the safety/efficacy of different doses of alteplase for acute ischaemic stroke in Taiwan. Methods: A prospective observational study was conducted in Taiwan. Eligible patients (1,004) were classified according to the dose of alteplase (or rt-PA) received for managing acute ischaemic stroke: 0.90± 0.5 mg/kg (422 patients, mean 0.91 ± 0.05 mg/kg, median 0.9 mg/kg, range 0.86-1.26mg/kg) as the standard dose group and < 0.85 mg/kg as the lower dose group, which was further divided into three subgroups: 0.80 ± 0.5 mg/kg (202 patients, mean 0.81 ± 0.03 mg/kg, median 0.81 mg/kg, range 0.76-0.85 mg/kg), 0.70 ± 0.5 mg/kg (199 patients, mean 0.71 ± 0.02 mg/kg, median 0.71 mg/kg, range 0.68-0.75 mg/kg) and 0.60 ± 0.5 mg/kg (181 patients, mean 0.62 ± 0.04 mg/kg, median 0.61 mg/kg, range 0.55-0.65 mg/kg). The primary outcome was: symptomatic intracerebral haemorrhage (SICH) and death within three months. The secondary outcome was good clinical outcome (modified Rankin scale (mRS) ≤ 1) at three months after thrombolytic therapy. Results: The overall SICH rates per the NINDS (6.8%) were comparable with the results of other observational studies, and the good functional outcomes (32.4%) were also similar after excluding patients aged ≥ 80 years and those with mRS score ≥ 2 before the index stroke. There was a significant trend for SICH with age ( P = 0.0025). From the lowest to the highest dose of alteplase in patients aged 71-80 years, we observed a significant trend of increasing SICH ( p =0.0130) and poorer functional outcome (P=0.0179). However, these trends did not exist in younger stroke patients. Conclusions: Consistent with our previous study, the standard dose of alteplase, 0.9 mg/kg, is not optimal for all acute ischaemic patients in an Asian population. In elderly patients (71-80 years), a lower dose of alteplase, 0.6 mg/kg, is associated with better safety/efficacy of thrombolytic therapy for ischaemic stroke in Chinese. However, randomized trials of lower versus higher dose are still needed.