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SHR Neuro Cancer Cardio Lipid Metab Microb
Galinovic, I; Fiebach, JB; Boutitie, F; Cheng, B; Cho, TH; Ebinger, M; Endres, M; Enzinger, C; Fiehler, J; Ford, I; Gregori, J; Günther, M; Lemmens, R; Muir, KW; Nighoghossian, N; Roy, P; Simonsen, CZ; Thijs, VN; Wouters, A; Gerloff, C; Thomalla, G; Pedraza, S, , for, WAKE-UP, Investigators.
Effect of IV Thrombolysis With Alteplase in Patients With Vessel Occlusion in the WAKE-UP Trial.
Neurology. 2025; 104(2):e209871
Doi: 10.1212/WNL.0000000000209871
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- Co-authors Med Uni Graz
- Enzinger Christian
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- Abstract:
- BACKGROUND AND OBJECTIVES: Data from randomized trials on the treatment effect of pure thrombolysis in patients with vessel occlusion are lacking. We examined data from a corresponding subsample of patients from the multicenter, randomized, placebo-controlled WAKE-UP trial to determine whether MRI-guided IV thrombolysis with alteplase in unknown-onset ischemic stroke benefits patients presenting with vessel occlusion. METHODS: Patients with an acute ischemic lesion visible on MRI diffusion-weighted imaging but no marked parenchymal hyperintensity on fluid-attenuated inversion recovery images were randomized to treatment with IV alteplase or placebo. The primary end point was a favorable outcome defined by a modified Rankin Scale score of 0-1 at 90 days after stroke. We investigated the interaction between vessel status and treatment effect using an unconditional logistic regression model. Treatment effects (adjusted odds ratio [aOR]) and their 95% CI were compared in patients with and without any vessel occlusion (AVO) and large vessel occlusion (LVO). RESULTS: 185 patients (mean age 64.5 years, 46% female, median NIH Stroke Scale score 9, median time between last seen well and MRI 10.26 hours) received treatment and presented with an occlusion. 98 (20%) had LVO (defined as occlusion of the internal carotid artery, middle cerebral artery trunk, or combination). A favorable outcome was observed in 30 of 94 patients with AVO (31.9%) in the alteplase group and in 18 of 91 (19.8%) in the placebo group (aOR 2.04, 95% CI 1.00-4.18). In the subgroup of patients with LVO, a favorable outcome was observed in 16 of 53 (30.2%) in the alteplase group and in 7 of 44 (15.9%) in the placebo group (aOR 2.08, 95% CI 0.71-6.10). Treatment with alteplase was associated with higher odds of favorable outcomes with no heterogeneity of treatment effect between patients with AVO and patent vessel (p = 0.56), or between patients with and without LVO (p = 0.69). DISCUSSION: Although the WAKE-UP study was not powered to demonstrate treatment efficacy in patient subpopulations, this subgroup analysis points to a benefit of MRI-guided thrombolysis in patients with unknown-onset ischemic stroke, independent of vessel occlusion. CLINICAL TRIAL REGISTRATION: Registered at ClinicalTrials.gov with unique identifier NCT01525290 (clinicaltrials.gov/study/NCT01525290). The study was first posted on February 2, 2012; the first patient was enrolled on September 24, 2012. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with unknown-onset ischemic stroke with AVO, MRI-guided treatment with IV tissue plasminogen activator improves outcomes.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Tissue Plasminogen Activator - administration & dosage, therapeutic use
- Female - administration & dosage
- Male - administration & dosage
- Middle Aged - administration & dosage
- Fibrinolytic Agents - administration & dosage, therapeutic use
- Aged - administration & dosage
- Ischemic Stroke - drug therapy, diagnostic imaging
- Thrombolytic Therapy - methods
- Treatment Outcome - administration & dosage
- Diffusion Magnetic Resonance Imaging - administration & dosage
- Double-Blind Method - administration & dosage