Abstract
BACKGROUND: The efficacy of intravenous thrombolysis is time-dependent. Reteplase has been shown to be superior to alteplase in certain acute ischemic stroke patients. OBJECTIVES: The authors aimed to delineate the associations of stroke onset-to-treatment time (OTT) on the therapeutic benefits and clinical risks with reteplase in comparison to alteplase. METHODS: This is a post hoc analysis of the RAISE (Reteplase versus Alteplase for Acute Ischemic Stroke) trial. Patients were divided into 3 groups based on their onset-to-treatment times: 0 to 90, 91 to 180, and 181 to 270 minutes. The primary efficacy outcome was the proportion of participants with a modified Rankin scale score of 0 to 1 at 90 days. The primary safety outcome was symptomatic intracranial hemorrhage within 36 hours post-thrombolytic treatment. RESULTS: A total of 1,399 patients (99.1%) with OTT (median 180 minutes; Q1-Q3: 135-222 minutes) were included. Adjusted risk ratios of primary efficacy outcome were 1.16 (95% CI: 0.70-1.91) for the 0 to 90 minutes group, 1.14 (95% CI: 0.97-1.35) for 91 to 180 minutes group, and 1.12 (95% CI: 0.93-1.18) for 181 to 270 minutes group. The primary safety outcome had no difference between reteplase and alteplase in the 3 OTT intervals. CONCLUSIONS: Among patients with ischemic stroke within 4.5 hours after symptom onset, there was no significant difference in the efficacy profile between reteplase and alteplase for achieving excellent functional outcomes at 3 different OTT intervals. (A Study of r-PA Treating Patients With Acute Ischemic Stroke [RAISE]; NCT05295173).