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@ARTICLE{Galinovic:274044,
author = {Galinovic, Ivana and Fiebach, Jochen B and Boutitie,
Florent and Cheng, Bastian and Cho, Tae-Hee and Ebinger,
Martin and Endres, Matthias and Enzinger, Christian and
Fiehler, Jens and Ford, Ian and Gregori, Johannes and
Günther, Matthias and Lemmens, Robin and Muir, Keith W and
Nighoghossian, N. and Roy, Pascal and Simonsen, Claus Z and
Thijs, Vincent N and Wouters, Anke and Gerloff, Christian
and Thomalla, Götz and Pedraza, Salvador},
collaboration = {Investigators, for WAKE-UP},
title = {{E}ffect of {IV} {T}hrombolysis {W}ith {A}lteplase in
{P}atients {W}ith {V}essel {O}cclusion in the {WAKE}-{UP}
{T}rial.},
journal = {Neurology},
volume = {104},
number = {2},
issn = {0028-3878},
address = {[Erscheinungsort nicht ermittelbar]},
publisher = {Ovid},
reportid = {DZNE-2025-00025},
pages = {e209871},
year = {2025},
abstract = {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.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).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).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.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.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.},
keywords = {Humans / Tissue Plasminogen Activator: administration $\&$
dosage / Tissue Plasminogen Activator: therapeutic use /
Female / Male / Middle Aged / Fibrinolytic Agents:
administration $\&$ dosage / Fibrinolytic Agents:
therapeutic use / Aged / Ischemic Stroke: drug therapy /
Ischemic Stroke: diagnostic imaging / Thrombolytic Therapy:
methods / Treatment Outcome / Diffusion Magnetic Resonance
Imaging / Double-Blind Method / Tissue Plasminogen Activator
(NLM Chemicals) / Fibrinolytic Agents (NLM Chemicals)},
cin = {AG Endres},
ddc = {610},
cid = {I:(DE-2719)1811005},
pnm = {353 - Clinical and Health Care Research (POF4-353)},
pid = {G:(DE-HGF)POF4-353},
typ = {PUB:(DE-HGF)16},
pubmed = {pmid:39705631},
pmc = {pmc:PMC11666272},
doi = {10.1212/WNL.0000000000209871},
url = {https://pub.dzne.de/record/274044},
}