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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},
}