Effect of IV Thrombolysis With Alteplase in Patients With Vessel Occlusion in the WAKE-UP Trial
(2025) Neurology — Vol. 104, n° 2, p. e209871 (2025)
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Galinovic, Ivana 
Fiebach, Jochen - et. al.
- 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 ran domized 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 in vestigated the interaction between vessel status and treatment effect using an unconditional logistic regression model. Treatment effects (adjusted odds ratio [aOR])andtheir 95%CIwere 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 anocclusion. 98 (20%)hadLVO(definedasocclusionoftheinternalcarotidartery, 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).
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Citations
Galinovic, I., Fiebach, J., Boutitie, F., Cheng, B., Cho, T.-H., Ebinger, M., Endres, M., Enzinger, C., Fiehler, J., Ford, I., Gregori, J., Günther, M., Lemmens, R., Muir, K., Nighoghossian, N., Roy, P., Simonsen, C., Thijs, V., Wouters, A., et al. (2025). Effect of IV Thrombolysis With Alteplase in Patients With Vessel Occlusion in the WAKE-UP Trial. Neurology, 104(2), e209871. https://doi.org/10.1212/wnl.0000000000209871 (Original work published 2025)