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Thrombolysis With Tenecteplase for Minor Disabling Stroke: Secondary Analysis of the TEMPO-2 Randomized Clinical Trial

Yiran Zhang, Brian H. Buck, P. A. Barber, Kausik Chatterjee, Brian Clarke, Philip M C Choi, G. Hunter, A. Ganesh et al.

JAMA Neurology, 2025

886 participants · 8 citations

Abstract

Importance

Outcomes following intravenous thrombolysis for minor ischemic stroke may vary based on the presence of disabling deficits.

Objective

To determine whether intravenous tenecteplase improves outcomes according to US National Institutes of Health Stroke Scale (NIHSS) score-based definitions of pretreatment disabling deficits.

Design, Setting, and Participants

This is a secondary analysis of the TEMPO-2 (Tenecteplase vs Standard of Care for Minor Ischemic Stroke With Proven Occlusion) randomized clinical trial, conducted between April 27, 2015, and January 19, 2024. Patients were followed up for 90 days. The TEMPO-2 trial was conducted across 48 sites globally among patients with minor ischemic stroke (NIHSS 0-5) and proven intracranial occlusion within 12 hours of onset. Patients were divided into having nondisabling vs disabling syndromes at presentation as per the TREAT Task Force consensus. Other established definitions of disabling stroke from the ARAMIS trial and the National Institute of Neurological Disorders and Stroke trial were explored. Data analysis was completed from July 2024 to September 2024.

Interventions

Intravenous tenecteplase (0.25 mg/kg) vs nonthrombolytic standard of care.

Main Outcomes and Measures

The primary outcome was a return to baseline modified Rankin scale score at 90 days.

Results

Among 886 enrolled patients, 2 withdrew consent and 884 were included in the secondary analysis. Among 884 patients analyzed (369 women [41.7%]; median…

How strong is the evidence?

Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 886 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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