Tenecteplase versus alteplase for acute ischaemic stroke in the elderly patients: a post hoc analysis of the TRACE-2 trial

特奈特普酶 医学 析因分析 缺血性中风 冲程(发动机) 纤溶剂 急性中风 内科学 组织纤溶酶原激活剂 急诊医学 心脏病学 溶栓 心肌梗塞 缺血 工程类 机械工程
作者
Yunyun Xiong,Liyuan Wang,Yuesong Pan,Mengxing Wang,Lee H. Schwamm,Chunmiao Duan,Bruce Campbell,Shuya Li,Manjun Hao,Na Wu,Zhixin Cao,Shuangzhe Wu,Zixiao Li,Yongjun Wang
出处
期刊:Stroke and vascular neurology [BMJ]
卷期号:: svn-003048 被引量:20
标识
DOI:10.1136/svn-2023-003048
摘要

Background The benefit–risk profile of tenecteplase in the elderly patients with acute ischaemic stroke (AIS) is uncertain. We sought to investigate the efficacy and safety of 0.25 mg/kg tenecteplase compared with alteplase for AIS patients aged ≥80 years. Methods We performed a post hoc analysis of the Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-2 Trial, a randomised, phase 3, non-inferiority clinical trial. Disabling AIS patients aged ≥80 years who initiated intravenous thrombolytics within 4.5 hours of symptom onset were enrolled from June 2021 to May 2022 across 53 centres in China and were randomly allocated to receive 0.25 mg/kg tenecteplase or 0.9 mg/kg alteplase. The primary efficacy outcome was the proportion of participants with a modified Rankin Scale (mRS) score of 0–1 at 90 days. Symptomatic intracranial haemorrhage (sICH) within 36 hours was the safety outcome. Results Of 137 participants, mRS 0–1 at 90 days occurred in 37 (49.3%) of 75 in the tenecteplase group vs 20 (33.9%) of 59 in the alteplase group (risk ratio (RR) 1.47, 95% CI 0.96 to 2.23). sICH within 36 hours was observed in 3 (4.0%) of 76 in the tenecteplase group and two (3.3%) of 61 in the alteplase group (RR 1.30, 95% CI 0.20 to 8.41). Conclusions The risk–benefit profile of tenecteplase thrombolysis was preserved in the elderly patients, which lends further support to intravenous 0.25 mg/kg tenecteplase as an alternative to alteplase in these patients.
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