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000274044 1001_ $$00000-0003-4904-8251$$aGalinovic, Ivana$$b0
000274044 245__ $$aEffect of IV Thrombolysis With Alteplase in Patients With Vessel Occlusion in the WAKE-UP Trial.
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000274044 520__ $$aData 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.
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000274044 650_7 $$0EC 3.4.21.68$$2NLM Chemicals$$aTissue Plasminogen Activator
000274044 650_7 $$2NLM Chemicals$$aFibrinolytic Agents
000274044 650_2 $$2MeSH$$aHumans
000274044 650_2 $$2MeSH$$aTissue Plasminogen Activator: administration & dosage
000274044 650_2 $$2MeSH$$aTissue Plasminogen Activator: therapeutic use
000274044 650_2 $$2MeSH$$aFemale
000274044 650_2 $$2MeSH$$aMale
000274044 650_2 $$2MeSH$$aMiddle Aged
000274044 650_2 $$2MeSH$$aFibrinolytic Agents: administration & dosage
000274044 650_2 $$2MeSH$$aFibrinolytic Agents: therapeutic use
000274044 650_2 $$2MeSH$$aAged
000274044 650_2 $$2MeSH$$aIschemic Stroke: drug therapy
000274044 650_2 $$2MeSH$$aIschemic Stroke: diagnostic imaging
000274044 650_2 $$2MeSH$$aThrombolytic Therapy: methods
000274044 650_2 $$2MeSH$$aTreatment Outcome
000274044 650_2 $$2MeSH$$aDiffusion Magnetic Resonance Imaging
000274044 650_2 $$2MeSH$$aDouble-Blind Method
000274044 7001_ $$00000-0002-7936-6958$$aFiebach, Jochen B$$b1
000274044 7001_ $$aBoutitie, Florent$$b2
000274044 7001_ $$aCheng, Bastian$$b3
000274044 7001_ $$00000-0001-8677-2447$$aCho, Tae-Hee$$b4
000274044 7001_ $$aEbinger, Martin$$b5
000274044 7001_ $$0P:(DE-2719)2811033$$aEndres, Matthias$$b6$$udzne
000274044 7001_ $$00000-0001-9764-7617$$aEnzinger, Christian$$b7
000274044 7001_ $$00000-0001-8533-7478$$aFiehler, Jens$$b8
000274044 7001_ $$aFord, Ian$$b9
000274044 7001_ $$aGregori, Johannes$$b10
000274044 7001_ $$aGünther, Matthias$$b11
000274044 7001_ $$00000-0002-4948-5956$$aLemmens, Robin$$b12
000274044 7001_ $$00000-0001-9535-022X$$aMuir, Keith W$$b13
000274044 7001_ $$aNighoghossian, N.$$b14
000274044 7001_ $$00000-0003-3837-3198$$aRoy, Pascal$$b15
000274044 7001_ $$00000-0003-1363-0266$$aSimonsen, Claus Z$$b16
000274044 7001_ $$00000-0002-6614-8417$$aThijs, Vincent N$$b17
000274044 7001_ $$00000-0001-5229-2699$$aWouters, Anke$$b18
000274044 7001_ $$aGerloff, Christian$$b19
000274044 7001_ $$00000-0002-4785-1449$$aThomalla, Götz$$b20
000274044 7001_ $$00000-0003-2517-4413$$aPedraza, Salvador$$b21
000274044 7001_ $$aInvestigators, for WAKE-UP$$b22$$eCollaboration Author
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