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

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http://hdl.handle.net/10138/306218

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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

Title: Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
Author: CLOTBUST-ER Trial Investigators; Alexandrov, Andrei V.; Tsivgoulis, Georgios; Köhrmann, Martin; Soinne, Lauri; Schellinger, Peter D.
Contributor: University of Helsinki, Clinicum
Date: 2019-07
Language: eng
Number of pages: 12
Belongs to series: Therapeutic advances in neurological disorders
ISSN: 1756-2856
URI: http://hdl.handle.net/10138/306218
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.
Subject: endovascular
equipoise shift
intracranial hemorrhage
mechanical thrombectomy
outcome
recanalization
sonothrombolysis
stroke
ultrasound-enhanced thrombolysis
THROMBECTOMY
MANAGEMENT
ULTRASOUND
EFFICACY
SAFETY
CARE
3112 Neurosciences
3124 Neurology and psychiatry
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