Post-hoc Analysis of Outcome of Intravenous Thrombolysis in Infarcts of Infratentorial Localization in the WAKE-UP Trial
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Post-hoc Analysis of Outcome of Intravenous Thrombolysis in Infarcts of Infratentorial Localization in the WAKE-UP Trial. / Galinovic, Ivana; Boutitie, Florent; Fiebach, Jochen B; Villringer, Kersten; Cheng, Bastian; Ebinger, Martin; Endres, Matthias; Fiehler, Jens; Ford, Ian; Thijs, Vincent; Lemmens, Robin; Muir, Keith W; Nighoghossian, Norbert; Pedraza, Salvador; Simonsen, Claus Z; Roy, Pascal; Gerloff, Christian; Thomalla, Götz.
In: FRONT NEUROL, Vol. 10, 2019, p. 983.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Post-hoc Analysis of Outcome of Intravenous Thrombolysis in Infarcts of Infratentorial Localization in the WAKE-UP Trial
AU - Galinovic, Ivana
AU - Boutitie, Florent
AU - Fiebach, Jochen B
AU - Villringer, Kersten
AU - Cheng, Bastian
AU - Ebinger, Martin
AU - Endres, Matthias
AU - Fiehler, Jens
AU - Ford, Ian
AU - Thijs, Vincent
AU - Lemmens, Robin
AU - Muir, Keith W
AU - Nighoghossian, Norbert
AU - Pedraza, Salvador
AU - Simonsen, Claus Z
AU - Roy, Pascal
AU - Gerloff, Christian
AU - Thomalla, Götz
N1 - Copyright © 2019 Galinovic, Boutitie, Fiebach, Villringer, Cheng, Ebinger, Endres, Fiehler, Ford, Thijs, Lemmens, Muir, Nighoghossian, Pedraza, Simonsen, Roy, Gerloff and Thomalla.
PY - 2019
Y1 - 2019
N2 - Introduction: In WAKE-UP (Efficacy and Safety of MRI-based Thrombolysis in Wake-Up Stroke), patients with an acute stroke of unknown onset time were randomized to treatment with intravenous alteplase or placebo, guided by MRI. Methods: In this exploratory post-hoc secondary analysis we compared clinical and imaging data, as well as treatment effects and safety of intravenous thrombolysis between patients with infra- vs. supratentorial stroke. Results: Forty-eight out of 503 randomized patients (9.5%) presented with a stroke involving the cerebellum or brainstem. Patients with infratentorial stroke were younger compared to patients with supratentorial stroke (mean age 60 vs. 66 years), more frequently male (85 vs. 62%), and less severely affected (median NIHSS 4.5 vs. 6.0). There was no heterogeneity for treatment effect between supratentorial (OR 1.67 95% CI 1.11-2.51) and infratentorial (OR 1.31 95% CI 0.41-4.22) sub-groups (test for interaction p = 0.70). In patients with infratentorial stroke, favorable outcome [a score of 0-1 on the modified Rankin scale (mRS) at 90 days] was observed in 12/22 patients (54.5%) in the alteplase group and in 13/25 patients (52.0%) in the placebo group (p = 0.59). The primary safety endpoint (death or mRS 4-6 at day 90) occurred in three patients of the alteplase group (13.6%) and three patients in the placebo group (12.0%); p = 0.74. Discussion: WAKE-UP was underpowered for demonstrating treatment effect in subgroup analyses however, based on our current results, there is no evidence to recommend withholding MRI-guided thrombolysis in patients with unknown onset stroke of infratentorial localization.
AB - Introduction: In WAKE-UP (Efficacy and Safety of MRI-based Thrombolysis in Wake-Up Stroke), patients with an acute stroke of unknown onset time were randomized to treatment with intravenous alteplase or placebo, guided by MRI. Methods: In this exploratory post-hoc secondary analysis we compared clinical and imaging data, as well as treatment effects and safety of intravenous thrombolysis between patients with infra- vs. supratentorial stroke. Results: Forty-eight out of 503 randomized patients (9.5%) presented with a stroke involving the cerebellum or brainstem. Patients with infratentorial stroke were younger compared to patients with supratentorial stroke (mean age 60 vs. 66 years), more frequently male (85 vs. 62%), and less severely affected (median NIHSS 4.5 vs. 6.0). There was no heterogeneity for treatment effect between supratentorial (OR 1.67 95% CI 1.11-2.51) and infratentorial (OR 1.31 95% CI 0.41-4.22) sub-groups (test for interaction p = 0.70). In patients with infratentorial stroke, favorable outcome [a score of 0-1 on the modified Rankin scale (mRS) at 90 days] was observed in 12/22 patients (54.5%) in the alteplase group and in 13/25 patients (52.0%) in the placebo group (p = 0.59). The primary safety endpoint (death or mRS 4-6 at day 90) occurred in three patients of the alteplase group (13.6%) and three patients in the placebo group (12.0%); p = 0.74. Discussion: WAKE-UP was underpowered for demonstrating treatment effect in subgroup analyses however, based on our current results, there is no evidence to recommend withholding MRI-guided thrombolysis in patients with unknown onset stroke of infratentorial localization.
U2 - 10.3389/fneur.2019.00983
DO - 10.3389/fneur.2019.00983
M3 - SCORING: Journal article
C2 - 31572293
VL - 10
SP - 983
JO - FRONT NEUROL
JF - FRONT NEUROL
SN - 1664-2295
ER -
