Xiong Yunyun, Wang Liyuan, Pan Yuesong, Wang Mengxing, Schwamm Lee H, Duan Chunmiao, Campbell Bruce C V, Li Shuya, Hao Manjun, Wu Na, Cao Zhixin, Wu Shuangzhe, Li Zixiao, Wang Yongjun
Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
China National Clinical Research Center for Neurological Diseases, Beijing, China.
Stroke Vasc Neurol. 2025 Feb 25;10(1):112-119. doi: 10.1136/svn-2023-003048.
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.
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.
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).
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.
替奈普酶用于老年急性缺血性卒中（AIS）患者的获益风险情况尚不确定。我们试图研究0.25mg/kg替奈普酶与阿替普酶相比，用于年龄≥80岁的AIS患者的疗效和安全性。
我们对急性缺血性脑血管事件-2替奈普酶再灌注治疗试验进行了事后分析，这是一项随机、3期、非劣效性临床试验。2021年6月至2022年5月期间，在中国53个中心招募了年龄≥80岁、在症状发作4.5小时内开始静脉溶栓治疗的致残性AIS患者，并将其随机分配接受0.25mg/kg替奈普酶或0.9mg/kg阿替普酶治疗。主要疗效结局是90天时改良Rankin量表（mRS）评分为0-1的参与者比例。36小时内的症状性颅内出血（sICH）为安全性结局。
137名参与者中，替奈普酶组75名中有37名（49.3%）在90天时mRS评分为0-1，而阿替普酶组59名中有20名（33.9%）（风险比（RR）1.47，95%CI 0.96至2.23）。替奈普酶组76名中有3名（4.0%）在36小时内发生sICH，阿替普酶组61名中有2名（3.3%）（RR 1.30，95%CI 0.20至8.41）。
替奈普酶溶栓的风险效益情况在老年患者中得以保留，这进一步支持静脉注射0.25mg/kg替奈普酶可作为这些患者阿替普酶的替代方案。
