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, 72Ϯ12 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 Ն1-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 Յ1. Analysis of 399 patients with a premorbid modified Rankin Scale score Յ1 who met the criteria of the European license (Յ80 years old, an initial National Institutes of Health Stroke Scale score Յ24, etc) showed that 40.6% (35.9% to 45.5%) had a 3-month modified Rankin Scale score Յ1. 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 Յ1.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.

Background: The initial 24 h after thrombolysis are critical for patients’ conditions, and continuous neurological assessment and blood pressure measurement are required during this time. The goal of this study was to identify the clinical factors associated with early neurological deterioration (END) within 24 h of stroke patients receiving intravenous recombinant tissue plasminogen activator (rt-PA) therapy and to clarify the effect of END on 3-month outcomes. Methods: A retrospective, multicenter, observational study was conducted in 10 stroke centers in Japan. A total of 566 consecutive stroke patients [211 women, 72 ± 12 years old, the median initial NIH Stroke Scale (NIHSS) score of 13] treated with intravenous rt-PA (0.6 mg/kg alteplase) was studied. END was defined as a 4-point or greater increase in the NIHSS score at 24 h from the NIHSS score just before thrombolysis. Results: END was present in 56 patients (9.9%, 18 women, 72 ± 10 years old) and was independently associated with higher blood glucose [odds ratio (OR) 1.17, 95% confidence intervals (CI) 1.07–1.28 per 1 mmol/l increase, p < 0.001], lower initial NIHSS score (OR 0.92, 95% CI 0.87–0.97 per 1-point increase, p = 0.002), and internal carotid artery (ICA) occlusion (OR 5.36, 95% CI 2.60–11.09, p < 0.001) on multivariate analysis. Symptomatic intracranial hemorrhage within the initial 36 h from thrombolysis was more common in patients with END than in the other patients (per NINDS/Cochrane protocol, OR 10.75, 95% CI 4.33–26.85, p < 0.001, and per SITS-MOST protocol, OR 12.90, 95% CI 2.76–67.41, p = 0.002). At 3 months, no patients with END had a modified Rankin Scale (mRS) score of 0–1. END was independently associated with death and dependency (mRS 3–6, OR 20.44, 95% CI 6.96–76.93, p < 0.001), as well as death (OR 19.43, 95% CI 7.75–51.44, p < 0.001), at 3 months. Conclusions: Hyperglycemia,lower baseline NIHSS score, and ICA occlusion were independently associated with END after rt-PA therapy. END was independently associated with poor 3-month stroke outcome after rt-PA therapy.

Background: The aim of this study was to determine whether renal dysfunction affects the outcome of stroke patients treated with recombinant tissue plasminogen activator (rt-PA). Methods: A retrospective, multicenter, observational study was conducted to identify the effects of underlying risk factors on intravenous rt-PA therapy using 0.6 mg/kg alteplase in 10 stroke centers in Japan. Consecutive stroke patients with a premorbid modified Rankin Scale (mRS) score ≤3 who received rt-PA were studied. Renal dysfunction was defined as estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m² on admission. The outcome measures were any intracerebral hemorrhage (ICH) and symptomatic ICH within the initial 36 h; favorable (mRS 0–1) outcome, poor outcome (mRS 4–6) and mortality at 3 months. Results: Of a total of 578 patients (372 men; 64.4%, 71.4 ± 11.7 years old), renal dysfunction was present in 186 patients (32.2%). These patients were older and more commonly had hypertension, atrial fibrillation, prior ischemic heart disease and prior use of antithrombotic agents than patients without renal dysfunction. ICH (27.4 vs. 16.6%) and symptomatic ICH (8.1 vs. 2.6%) was more common in patients with renal dysfunction than in those without. At 3 months, patients with renal dysfunction had higher median mRS scores than those without (3 vs. 2). After multivariate adjustment for established outcome predictors, renal dysfunction was related to any ICH (odds ratio 1.81, 95% confidence interval 1.16–2.84), symptomatic ICH (2.64, 1.10–6.56), poor outcome (1.55, 1.01–2.38), and mortality (2.94, 1.38–6.42). Conclusions: Reduced eGFR was associated with early ICH and 3-month unfavorable outcome in stroke patients receiving intravenous rt-PA.

ASPECTS on DWI was independently predictive of functional and vital outcomes at 3 months, as well as sICH within 36 hours, following rt-PA therapy for stroke patients.