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dc.contributorVall d'Hebron Barcelona Hospital Campus
dc.contributor.authorAlexandrov, Andrei V.
dc.contributor.authorTsivgoulis, Georgios
dc.contributor.authorKöhrmann, Martin
dc.contributor.authorKatsanos, Aristeidis H.
dc.contributor.authorSoinne, Lauri
dc.contributor.authorBarreto, Andrew D.
dc.contributor.authorMolina Cateriano, Carlos
dc.date.accessioned2020-02-12T10:47:55Z
dc.date.available2020-02-12T10:47:55Z
dc.date.issued2019-07-12
dc.identifier.citationAlexandrov AV, Tsivgoulis G, Köhrmann M, Katsanos AH, Soinne L, Barreto AD, et al. Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke. Ther Adv Neurol Disord. 2019 Jan 12;12:175628641986065.
dc.identifier.issn1756-2856
dc.identifier.urihttp://hdl.handle.net/11351/4613
dc.descriptionSonothrombolysis; Endovascular; Equipoise shift
dc.description.abstractBackground: 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.
dc.language.isoeng
dc.publisherSAGE Publications
dc.relation.ispartofseriesTherapeutic Advances in Neurological Disorders;12
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
dc.sourceScientia
dc.subjectVasos sanguinis - Cirurgia
dc.subjectTeràpia trombolítica
dc.subject.meshEndovascular Procedures
dc.subject.meshThrombolytic Therapy
dc.subject.meshTherapeutic Equipoise
dc.titleEndovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1177/1756286419860652
dc.subject.decsprocedimientos endovasculares
dc.subject.decsequiponderación terapéutica
dc.subject.decstratamiento trombolítico
dc.relation.publishversionhttps://journals.sagepub.com/doi/10.1177/1756286419860652
dc.type.versioninfo:eu-repo/semantics/publishedVersion
dc.audienceProfessionals
dc.contributor.authoraffiliation[Alexandrov AV] Department of Neurology, University of Tennessee Health Science Center, Memphis, USA. [Tsivgoulis G] ] Department of Neurology, University of Tennessee Health Science Center, Memphis, USA. Second Department of Neurology, ‘Attikon’ University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece. [Köhrmann M] Department of Neurology, Universitaetsklinikum Erlangen, Erlangen, Germany. Department of Neurology, University Duisburg-Essen, Essen, Germany. [Katsanos AH] Second Department of Neurology, ‘Attikon’ University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece. Department of Neurology, St Josef Hospital, Ruhr University Bochum, Bochum, Germany. [Soinne L] Department of Neurology, Helsinki University Hospital and Clinical Neurosciences, Neurology, University of Helsinki, Helsinki, Finland. [Barreto AD] Department of Neurology, University of Texas Health Science Center at Houston, Houston, USA. [Molina CA] Servei de Neurologia, Hospital Universitari Vall d’Hebron, Barcelona, Spain. Recerca en Ictus, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Barcelona, Spain.
dc.identifier.pmid31320933
dc.identifier.wos000478614500001
dc.rights.accessrightsinfo:eu-repo/semantics/openAccess


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