By medicine.net editorial team

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The International Stroke Conference held at the Phoenix Convention Center from February 6th to February 9th, 2024 featured a presentation by Yunyunxiong from Tian Tan Hospital in China, outlining their team's clinical trial comparing tenecteplase (TNK) and alteplase in the oldest acute ischemic stroke (AIS) patients.

The benefit-risk profile of tenecteplase (TNK) in the oldest acute ischemic stroke (AIS) patients remains uncertain. The team evaluated the efficacy and safety of 0.25 mg/kg TNK compared to the same dose of alteplase in AIS patients aged ≥80 years.

Yunyunxiong et al. conducted a pre-specified subgroup analysis of the Tenecteplase Reperfusion Therapy for Acute Ischemic Cerebrovascular Events-2 (TRACE-2) trial, a randomized, phase 3, non-inferiority clinical trial. The team recruited a total of 137 disabling ischemic stroke patients aged ≥80 years who initiated intravenous thrombolysis within 4.5 hours after onset but were not eligible for endovascular thrombectomy, from 53 medical centers in China from June 2021 to May 2022. They were randomly assigned to receive intravenous injection of 0.25 mg/kg TNK or 0.9 mg/kg alteplase. The primary efficacy outcome was the proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days, evaluated in the modified intention-to-treat (mITT) population, with a non-inferiority margin for risk ratio (RR) of 0.937. The primary safety outcome was symptomatic intracranial hemorrhage (sICH) within 36 hours, evaluated in the safety analysis set.

In the TRACE-2 trial, the risk-benefit profile of TNK thrombolysis was preserved in the oldest patients, further supporting the use of intravenous 0.25 mg/kg TNK as an alternative thrombolytic agent to alteplase.

Prior to the conference, another team led by Liuliang from China conducted a meta-analysis of acute ischemic stroke patients treated with tenecteplase and alteplase. They concluded that compared to alteplase, intravenous thrombolysis with TNK at a dose of 0.25 mg/kg had superior efficacy and similar safety, making it a reasonable choice for AIS patients.

The conclusion of the meta-analysis aligns with the results inferred from the clinical trial mentioned at the International Stroke Conference. The conclusion that tenecteplase has superior efficacy and similar safety is more convincing, providing stronger evidence for the future clinical application of tenecteplase.

More information:

  1. Tenecteplase versus Alteplase for Acute Ischemic Stroke in the Oldest-Old Patients,ISC 2024.

  2. Tenecteplase versus alteplase for patients with acute ischemic stroke: a meta-analysis of randomized controlled trials,DOI: 10.18632/aging.205315.