Objective To analyze the efficacy and safety of reteplase versus alteplase in acute ischemic stroke (AIS) patients complicated with arrhythmia.
Methods The RAISE (reteplase versus alteplase for acute ischaemic stroke within 4.5 hours) study was a multicenter, randomized, controlled, open-label, outcome-blinded phase Ⅲ clinical trial designed to compare reteplase and alteplase in the treatment of AIS patients within 4.5 hours of onset. This study was a post-hoc analysis of AIS patients complicated with arrhythmia enrolled in the RAISE study. Patients were divided into the reteplase group and the alteplase group according to the thrombolytic agent administered. The primary efficacy outcome was the proportion of patients achieving an mRS score of 0-1 at 90 days post-thrombolysis, and the primary safety outcome was the occurrence of symptomatic intracranial hemorrhage within 36 hours post-thrombolysis. This study compared the clinical efficacy and safety differences between the two thrombolytic agents in AIS patients complicated with arrhythmia.
Results A total of 129 AIS patients complicated with arrhythmia were included in this study, with 59 cases in the reteplase group and 70 cases in the alteplase group. For the primary efficacy outcome, the proportion of patients achieving an mRS score of 0-1 at 90 days post-thrombolysis in the reteplase group showed a trend toward being higher than that in the alteplase group, but the difference was not statistically significant (68.4% vs. 66.2%, RR 1.07, 95%CI 0.85-1.35, P=0.560). For the secondary efficacy outcome, the proportion of patients with significant neurological improvement (defined as a reduction in NIHSS score≥4 points or an NIHSS score≤1) at 7 days post-thrombolysis was significantly higher in the reteplase group than in the alteplase group (78.9% vs. 61.2%, RR 1.25, 95%CI 1.03-1.51, P=0.021). No statistically significant differences were observed in all safety outcomes between the two thrombolytic agents in the treatment of AIS patients complicated with arrhythmia. Specifically, the rates of symptomatic intracranial hemorrhage within 36 hours post-thrombolysis were 1.7% in the reteplase group and 1.4% in the alteplase group (RR 1.07, 95%CI 0.07-15.25, P=0.963), and the mortality within 90 days post-thrombolysis was 10.2% and 5.7%, respectively (RR 1.41, 95%CI 0.49-4.07, P=0.520).
Conclusions For AIS patients complicated with arrhythmia within 4.5 hours of onset, reteplase and alteplase exhibited comparable efficacy and safety. Therefore, reteplase may be considered as an alternative to alteplase in thrombolytic therapy.