TNK Up to 24 Hours for Stroke?

August 9, 2024

Written by Micheal Stocker

Spoon Feed
In patients with large vessel occlusions(LVO) presenting 4.5-24 hours after onset, without access to endovascular thrombectomy (ET), tenecteplase (TNK) administration bested standard medical treatment (SMT) in 90-day disability-free recovery.

TNK up to one day?
Performed across 58 centers in China, the TRACE-III phase 3 trial sought to compare TNK to SMT in patients presenting between 4.5 to 24 hours after last known well with internal carotid artery (ICA) or middle cerebral artery (M1 or M2) LVO and without access to ET. 516 patients 18 years and older with NIH scores ranging 6 to 25, imaging evidence of ICA, M1, or M2 occlusion and salvageable brain tissue based on perfusion imaging were randomized 1:1 to receive TNK (264) or SMT (252). 90-day modified Rankin scale score of 0 or 1 was the primary outcome, while worsening of NIH score by 4 or more points or death due to symptomatic intracranial hemorrhage (sICH) within 36 hours, significant systemic bleeding within 90 days, and all-cause death were the safety outcomes of interest. TNK outperformed SMT in the primary outcome (33.0% vs 24.2%, RR 1.37; 95%CI 1.04-1.81) without statistically significant differences in the safety outcomes. However, while low, the incidence of sICH and significant systemic bleeding with TNK were at least triple and double that of SMT, respectively (sICH 3.0% vs 0.8%, RR 3.82; 95%CI 0.82-17.87) (bleeding 1.9% vs 0.8%, RR 2.36; 0.46-12.09). This study may be underpowered to fully detect the potential risks of TNK in this population.

How with this change my practice?
It probably won’t – at least not at my current shop, which is a comprehensive stroke center. Docs without ET have some support for TNK up to 24 hours, but the signal of increased sICH should give pause and prompt thorough risks/benefits discussions. Keep an eye out for ongoing trials, ETERNAL-LVO and POST-ETERNAL.

Source
Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy. N Engl J Med. 2024 Jun 14. doi: 10.1056/NEJMoa2402980. Epub ahead of print. PMID: 38884324.