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TRACE-2 RCT – Tenecteplase vs Alteplase for Stroke

May 22, 2023

Written by Laura Murphy

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Tenecteplase was non-inferior to alteplase in patients with acute ischemic stroke who were eligible for intravenous thrombolytic therapy but ineligible or refused endovascular thrombectomy.

Why does this matter?
This study improves the current understanding of efficacy and safety of tenecteplase in Asian populations. 

Step aside alteplase?
This was a multicenter, prospective, open-label, blinded-endpoint randomized controlled non-inferiority trial which studied adults with acute ischemic stroke who were eligible for intravenous thrombolysis but ineligible for endovascular thrombectomy at 53 centers in China. Participants were randomly assigned to receive IV tenecteplase (0.25 mg/kg, max dose of 25 mg) or IV alteplase (0.9 mg/kg, max dose 90 mg). The trial included patients who were able to receive treatment within 4.5 hours of stroke, have a modified Rankin score (mRS) ≤1 at enrollment, and NIH Stroke Scale of 5-25.

A total of 1430 patients were randomized, and the mean NIHSS was 7. Primary efficacy outcome was the proportion of patients with mRS score of 0-1 at 90 days measured in the modified intention-to-treat population. This occurred in in 62% of the tenecteplase group vs 58% of the alteplase group (RR 1.07, 95%CI 0.98-1.16). The lower limit of RR’s 95% CI was greater than the non-inferiority margin of 0.937. There were no significant differences in secondary functional outcomes. Symptomatic intracranial hemorrhage within 36 hours was the primary safety outcome and was observed in 2% of the tenecteplase group and 2% of the alteplase group (RR 1.18, 95%CI 0.56-2.50). No statistically significant difference in 90-day mortality was observed between groups (7% vs 5%, RR 1.31, 95%CI: 0.86-2.01).

In addition to the AcT trial, this study strengthens the evidence that tenecteplase is a reasonable alternative to alteplase by demonstrating non-inferiority in participants from different ethnic backgrounds. Unlike the AcT trial, TRACE-2 excluded participants who were planned to undergo endovascular thrombectomy. Excluding this patient group may limit generalizability as well as the ability to determine superiority or non-inferiority in patients undergoing endovascular thrombectomy.  

There have now been multiple studies comparing tenecteplase and alteplase in acute ischemic stroke which have demonstrated that, in terms of efficacy, tenecteplase is non-inferior to the current standard of care and has similar safety. It also has a practical advantage in terms of its ease of administration. With this in mind, I suspect we will be seeing broader use of tenecteplase in the U.S. soon, as reflected in European and Canadian guidelines.

Tenecteplase versus alteplase in acute ischaemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomised controlled, non-inferiority trial. Lancet. 2023 Feb 8;S0140-6736(22)02600-9. doi: 10.1016/S0140-6736(22)02600-9. Online ahead of print.

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