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Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
AV. Alexandrov, G. Tsivgoulis, M. Köhrmann, AH. Katsanos, L. Soinne, AD. Barreto, T. Rothlisberger, VK. Sharma, R. Mikulik, KW. Muir, CR. Levi, CA. Molina, M. Saqqur, D. Mavridis, T. Psaltopoulou, MR. Vosko, JB. Fiebach, P. Mandava, TA. Kent, AW....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články
NLK
Directory of Open Access Journals
od 2017
Free Medical Journals
od 2008
PubMed Central
od 2008
Europe PubMed Central
od 2008
ProQuest Central
od 2016-01-01
Health & Medicine (ProQuest)
od 2016-01-01
ROAD: Directory of Open Access Scholarly Resources
od 2008
PubMed
31320933
DOI
10.1177/1756286419860652
Knihovny.cz E-zdroje
- Publikační typ
- časopisecké články MeSH
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.
Center for Stroke Research Berlin Charité University Medicine Berlin Berlin Germany
Cerevast Therapeutics Inc Redmond WA USA
Department of Medicine University of Alberta Edmonton Alberta Canada
Department of Neurology 2 Med Campus 3 Kepler University Hospital Linz Austria
Department of Neurology John Hunter Hospital University of Newcastle Newcastle Australia
Department of Neurology Universitaetsklinikum Erlangen Erlangen Germany
Department of Neurology University of Tennessee Health Science Center Memphis TN USA
Department of Neurology University of Texas Health Science Center at Houston Houston TX USA
Department of Primary Education School of Education University of Ioannina Ioannina Greece
Stroke Outcomes Laboratory Department of Neurology Baylor College of Medicine Houston TX USA
Citace poskytuje Crossref.org
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- $a 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.
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