Thrombolysis With Tenecteplase for Minor Disabling Stroke: Secondary Analysis of the TEMPO-2 Randomized Clinical Trial.
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Zhang Yiran, Buck Brian H, Barber Philip A, Chatterjee Kausik, Clarke Brian, Choi Philip M C, Hunter Gary, Ganesh Aravind, Mishra Sachin M, Williams David, Campbell Bruce C V, Dowlatshahi Dar, Butcher Ken S, Krishnan Kailash, Wiggam M Ivan, Kleinig Timothy J, Muir Keith W, Zerna Charlotte, Field Thalia S, Goyal Mayank, Yu Amy Y X, Roffe Christine, Demchuck Andrew M, Parsons Mark W, Bazan Rodrigo, Ankolekar Sandeep, Kennedy James, Menon Bijoy K, Mandzia Jennifer L, Pille Arthur, Kelly Peter J, Marko Martha, Singh Nishita, Vatanpour Shabnam, Lima Fabrico O, Catanese Luciana, Horn MacKenzie, Ghia Darshan, Ferrari Julia, Greisenegger Stefen, Hill Michael D, Coutts Shelagh B, TEMPO-2 Investigators
Аннотация
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 [IQR] age, 72 [61-80] years), 100 (11.3%) had disabling and 784 (88.7%) had nondisabling deficits. Patients with disabling deficits had higher median (IQR) baseline NIHSS scores (4 [3-5] vs 2 [1-3]), later presentations (onset to hospital arrival time: 288 [153-412] minutes vs 133 [70-310] minutes), and longer onset to treatment time (411 [307-560] minutes vs 278 [170-462] minutes) than those with nondisabling deficits. In the disabling group, the primary outcome following tenecteplase, compared with standard of care, occurred in 29 patients (54.7%) vs 32 patients (68.1%) (adjusted risk ratio [aRR], 0.81; 95% CI, 0.60-1.10). This neutral treatment effect was consistent in patients without disabling deficits (280 [73.9%] vs 306 [75.6%]; aRR, 0.98; 95% CI, 0.91-1.07; P for interaction = .32).
CONCLUSIONS AND RELEVANCE: In this secondary analysis of the TEMPO-2 randomized clinical trial, current definitions of disabling symptoms based on NIHSS score at baseline did not modify the neutral treatment effect of intravenous tenecteplase in patients with minor stroke and intracranial occlusion. Together with converging evidence comparing intravenous thrombolysis to nonthrombolytic standard of care, this analysis suggests the need to reevaluate thrombolysis in minor disabling stroke.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02398656.