Intra-arterial tenecteplase during thrombectomy for acute ischemic stroke: the BRETIS-TNK2 trial

Intra-arterial tenecteplase during endovascular treatment (EVT) may increase first-pass recanalization and dissolve microcirculatory thrombi, but its efficacy and safety are uncertain. We hypothesised that this strategy would improve functional outcomes versus EVT alone. This phase 3, randomised, adaptive-enrichment, open-label, blinded-endpoint multicentre study aims to evaluate whether intra‑arterial tenecteplase improves clinical outcomes for patients with acute ischemic stroke. Patients with large‑vessel occlusion eligible for EVT within 24 hours of symptom onset were randomly assigned (1:1) to the tenecteplase group receiving intra‑arterial tenecteplase during EVT or the control group receiving EVT alone. The primary endpoint was favorable functional outcome. Of 380 randomised patients (192 in the tenecteplase group and 188 in the control group), primary outcome data were available for 190 and 186 patients, respectively. Favorable 90-day functional outcomes (modified Rankin Scale 0–2) occurred in 40.0% of the tenecteplase group versus 46.8% of the control group (unadjusted odds ratio 0.76, [95% CI 0.50–1.14], P = 0.19). This work suggests intra-arterial tenecteplase during thrombectomy did not improve 90-day functional outcomes in this population. (Funded by National Science and Technology Major Project and hospital-initiated grants; ClinicalTrials.gov registration: NCT05657444) It is unclear whether adjunct intra-arterial Tenecteplase during thrombectomy improves clinical outcomes in patients with acute large vessel occlusion. Here, the authors show that adjunct intra-arterial tenecteplase during thrombectomy does not improve 90-day functional outcomes in this population.