Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke

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dc.contributor.author CLOTBUST-ER Trial Investigators
dc.contributor.author Alexandrov, Andrei V.
dc.contributor.author Tsivgoulis, Georgios
dc.contributor.author Köhrmann, Martin
dc.contributor.author Soinne, Lauri
dc.contributor.author Schellinger, Peter D.
dc.date.accessioned 2019-10-21T06:34:01Z
dc.date.available 2019-10-21T06:34:01Z
dc.date.issued 2019-07
dc.identifier.citation CLOTBUST-ER Trial Investigators , Alexandrov , A V , Tsivgoulis , G , Köhrmann , M , Soinne , L & Schellinger , P D 2019 , ' Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke ' , Therapeutic advances in neurological disorders , vol. 12 , 1756286419860652 . https://doi.org/10.1177/1756286419860652
dc.identifier.other PURE: 127547592
dc.identifier.other PURE UUID: 7703c112-9c13-462e-8cab-32ad99c86ce0
dc.identifier.other WOS: 000478614500001
dc.identifier.uri http://hdl.handle.net/10138/306218
dc.description.abstract Background: Results of our recently published phase III randomized clinical trial of ultrasound-enhanced thrombolysis (sonothrombolysis) using an operator-independent, high frequency ultrasound device revealed heterogeneity of patient recruitment among centers. Methods: We performed a post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p <0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06-0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89-1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0-2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01-2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies. en
dc.format.extent 12
dc.language.iso eng
dc.relation.ispartof Therapeutic advances in neurological disorders
dc.rights cc_by_nc
dc.rights.uri info:eu-repo/semantics/openAccess
dc.subject endovascular
dc.subject equipoise shift
dc.subject intracranial hemorrhage
dc.subject mechanical thrombectomy
dc.subject outcome
dc.subject recanalization
dc.subject sonothrombolysis
dc.subject stroke
dc.subject ultrasound-enhanced thrombolysis
dc.subject MANAGEMENT
dc.subject ULTRASOUND
dc.subject EFFICACY
dc.subject SAFETY
dc.subject CARE
dc.subject 3112 Neurosciences
dc.subject 3124 Neurology and psychiatry
dc.title Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke en
dc.type Article
dc.contributor.organization Clinicum
dc.contributor.organization HUS Neurocenter
dc.contributor.organization University Management
dc.contributor.organization Department of Neurosciences
dc.contributor.organization Neurologian yksikkö
dc.description.reviewstatus Peer reviewed
dc.relation.doi https://doi.org/10.1177/1756286419860652
dc.relation.issn 1756-2856
dc.rights.accesslevel openAccess
dc.type.version publishedVersion

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