Background and purpose: A retrospective, multicenter, observational study was conducted to document clinical outcomes and to identify outcome predictors in patients treated with low-dose intravenous recombinant tissue plasminogen activator (0.6 mg/kg alteplase), which was approved in Japan in 2005, within 3 hours of stroke onset.
Methods: Consecutive patients with stroke treated with recombinant tissue plasminogen activator in 10 Japanese stroke centers were included.
Results: A total of 600 patients (377 men, 72+/-12 years old) were studied. Median National Institutes of Health Stroke Scale scores decreased from 13 before recombinant tissue plasminogen activator to 8 at 24 hours later. Symptomatic intracerebral hemorrhage within 36 hours with a >or=1-point increase from the baseline National Institutes of Health Stroke Scale score developed in 23 patients (3.8%; 95% CI, 2.6% to 5.7%). At 3 months, 43 patients had died (7.2%; 5.4% to 9.5%), and 199 patients (33.2%; 29.5% to 37.0%) had a modified Rankin Scale score <or=1. Analysis of 399 patients with a premorbid modified Rankin Scale score <or=1 who met the criteria of the European license (<or=80 years old, an initial National Institutes of Health Stroke Scale score <or=24, etc) showed that 40.6% (35.9% to 45.5%) had a 3-month modified Rankin Scale score <or=1. After multivariate adjustment, younger age, lower initial National Institutes of Health Stroke Scale score, absence of internal carotid artery occlusion, higher Alberta Stroke Program Early CT Score on CT, and absence of intravenous antihypertensives just before recombinant tissue plasminogen activator were independently related to a 3-month modified Rankin Scale score <or=1. Congestive heart failure and hyperglycemia were independently related to mortality.
Conclusions: Three-month outcomes of patients receiving low-dose intravenous recombinant tissue plasminogen activator therapy in the present study were similar to those from postmarketing surveys using 0.9 mg/kg alteplase.