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Title: Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke.
Authors: Alexandrov, Andrei V
Tsivgoulis, Georgios
K�hrmann, Martin
Katsanos, Aristeidis H
Soinne, Lauri
Barreto, Andrew D
Rothlisberger, Travis
Sharma, Vijay K 
Mikulik, Robert
Muir, Keith W
Levi, Christopher R
Molina, Carlos A
Saqqur, Maher
Mavridis, Dimitris
Psaltopoulou, Theodora
Vosko, Milan R
Fiebach, Jochen B
Mandava, Pitchaiah
Kent, Thomas A
Alexandrov, Anne W
Schellinger, Peter D
CLOTBUST-ER Trial Investigators
Keywords: endovascular
equipoise shift
intracranial hemorrhage
mechanical thrombectomy
ultrasound-enhanced thrombolysis
Issue Date: 2019
Publisher: SAGE Publications
Citation: Alexandrov, Andrei V, Tsivgoulis, Georgios, K�hrmann, Martin, Katsanos, Aristeidis H, Soinne, Lauri, Barreto, Andrew D, Rothlisberger, Travis, Sharma, Vijay K, Mikulik, Robert, Muir, Keith W, Levi, Christopher R, Molina, Carlos A, Saqqur, Maher, Mavridis, Dimitris, Psaltopoulou, Theodora, Vosko, Milan R, Fiebach, Jochen B, Mandava, Pitchaiah, Kent, Thomas A, Alexandrov, Anne W, Schellinger, Peter D, CLOTBUST-ER Trial Investigators (2019). Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke.. European Stroke Organization Conference 12 : 1756286419860652-. ScholarBank@NUS Repository.
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.
Source Title: European Stroke Organization Conference
ISSN: 17562856
DOI: 10.1177/1756286419860652
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