PT  - JOURNAL ARTICLE
AU  - Xiong, Yunyun
AU  - Wang, Liyuan
AU  - Pan, Yuesong
AU  - Wang, Mengxing
AU  - Schwamm, Lee H
AU  - Duan, Chunmiao
AU  - Campbell, Bruce C V
AU  - Li, Shuya
AU  - Hao, Manjun
AU  - Wu, Na
AU  - Cao, Zhixin
AU  - Wu, Shuangzhe
AU  - Li, Zixiao
AU  - Wang, Yongjun
TI  - Tenecteplase versus alteplase for acute ischaemic stroke in the elderly patients: a post hoc analysis of the TRACE-2 trial
AID  - 10.1136/svn-2023-003048
DP  - 2024 Jun 10
TA  - Stroke and Vascular Neurology
PG  - svn-2023-003048
4099  - http://svn.bmj.com/content/early/2024/06/10/svn-2023-003048.short
4100  - http://svn.bmj.com/content/early/2024/06/10/svn-2023-003048.full
AB  - 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.Data are available on reasonable request.