摘要
Abstract
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) studywas a multicenter,randomized,controlled,open-label,outcome-blinded phase Ⅲ clinical trialdesigned to compare reteplase and alteplase in the treatment of AIS patients within 4.5 hours ofonset. This study was a post-hoc analysis of AIS patients complicated with arrhythmia enrolled inthe 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 patientsachieving an mRS score of 0-1 at 90 days post-thrombolysis,and the primary safety outcome wasthe occurrence of symptomatic intracranial hemorrhage within 36 hours post-thrombolysis. Thisstudy compared the clinical efficacy and safety differences between the two thrombolytic agents inAIS 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 efficacyoutcome,the proportion of patients achieving an mRS score of 0-1 at 90 days post-thrombolysisin the reteplase group showed a trend toward being higher than that in the alteplase group,but thedifference 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 neurologicalimprovement (defined as a reduction in NIHSS score≥4 points or an NIHSS score≤1) at 7 dayspost-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 differenceswere observed in all safety outcomes between the two thrombolytic agents in the treatment of AISpatients complicated with arrhythmia. Specifically,the rates of symptomatic intracranial hemorrhagewithin 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 was10.2％ 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 andalteplase exhibited comparable efficacy and safety. Therefore,reteplase may be considered as analternative to alteplase in thrombolytic therapy.关键词
急性缺血性卒中/瑞替普酶/阿替普酶/心律失常Key words
Acute ischemic stroke/Reteplase/Alteplase/Arrhythmia分类
医药卫生
