ISC 2023 | TRACE II results: tenecteplase versus alteplase for IVT

Shuya Li, MD, Beijing Tiantan Hospital, Capital Medical University, Beijing, China, presents an overview of the Phase III multicenter, randomized, controlled TRACE II trial (NCT04797013), which reported positive findings at the International Stroke Conference 2023. The trial aimed to demonstrate the non-inferiority of tenecteplase compared to alteplase for intravenous thrombolysis to treat acute ischemic stroke within 4.5 hours of symptom onset. Over 1400 patients were randomized, all of whom were eligible for intravenous thrombolysis, but ineligible for/refused endovascular thrombectomy. The proportion of patients achieving an excellent functional outcome (mRS 0-1) at 90 days was comparable: 62.3% in the tenecteplase group versus 58.2% in the alteplase group. These data showed tenecteplase to be non-inferior to alteplase, with a non-inferiority margin of 3.74% for absolute risk difference. Rates of symptomatic intracranial hemorrhage and death were also similar. This interview took place during the International Stroke Conference (ISC) 2023 in Dallas, TX.

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