# Phase 3 BRETIS-TNK2 trial finds intra-arterial tenecteplase does not improve stroke outcomes

- Published: 2026-11-07 21:59 UTC
- Section: Life & Health › Medicine
- Tags: intra-arterial tenecteplase, acute ischemic stroke, endovascular thrombectomy, large vessel occlusion, BRETIS-TNK2 trial, modified Rankin Scale
- URL: https://realtech.media/news/rt-5f14092c7cb985cb2d330207_phase_3_bretis/

**A randomized trial of 380 patients evaluated intra-arterial tenecteplase during thrombectomy, reporting no 90-day functional benefit over thrombectomy alone.**

![Phase 3 BRETIS-TNK2 trial finds intra-arterial tenecteplase does not improve stroke outcomes](https://realtech.media/media/2026/11/aa06e566e19ee6c3.png)
*Nature Communications*

Intra-arterial administration of tenecteplase during endovascular thrombectomy did not improve 90-day functional recovery in acute ischemic stroke patients with large-vessel occlusion, according to phase 3 study results published in *Nature Communications* [1]. The randomized, multicenter BRETIS-TNK2 trial evaluated whether combining intra-arterial thrombolysis with mechanical clot retrieval could clear microcirculatory thrombi and prevent the no-reflow phenomenon compared with thrombectomy alone.

Between April 2023 and December 2024, researchers enrolled 380 adult patients eligible for endovascular treatment within 24 hours of symptom onset [1]. Participants were randomly allocated to either intra-arterial tenecteplase administered during thrombectomy (192 patients) or standard thrombectomy alone (188 patients) [1]. Demographics and baseline characteristics were balanced between cohorts, with a median age of 65 years and a median baseline National Institutes of Health Stroke Scale score of 14 across both groups [1].

## Primary functional endpoint

The primary outcome assessed functional independence at 90 days, defined as a modified Rankin Scale score of 0 to 2 [1]. Primary endpoint data were documented for 190 patients in the tenecteplase arm and 186 in the control arm [1].

Favorable outcomes occurred in 40.0% of the tenecteplase group compared with 46.8% of the control group [1]. The unadjusted odds ratio was 0.759 (95% CI 0.504–1.142; P = 0.185), and the adjusted odds ratio was 0.688 (95% CI 0.451–1.049; P = 0.083), showing no statistically significant clinical advantage for the adjunctive intra-arterial infusion [1].

## Secondary angiographic parameters

Secondary angiographic endpoints assessed successful reperfusion rates after the final retrieval pass during the endovascular procedure [1]. In the intention-to-treat cohort, successful recanalization reached 95.8% (184 of 192 patients) in the tenecteplase arm and 91.4% (172 of 188 patients) in the control group (unadjusted OR 2.140, 95% CI 0.893–5.126; P = 0.088) [1]. 

In the per-protocol population of 366 patients, successful reperfusion was noted in 96.7% (178 of 184) of tenecteplase recipients versus 91.7% (167 of 182) of controls (unadjusted OR 2.665, 95% CI 1.010–7.029; P = 0.048) [1]. Despite the technical recanalization trends, the authors concluded that intra-arterial tenecteplase during thrombectomy failed to yield superior 90-day neurological recovery [1].

## Sources

1. [Nature Communications](https://doi.org/10.1038/s41467-026-79178-1)

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Source: RealTech, realtech.media — https://realtech.media/news/rt-5f14092c7cb985cb2d330207_phase_3_bretis/