Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
Alexandrov, Andrei V. (University of Tennessee Health Science Center)
Tsivgoulis, Georgios (University of Tennessee Health Science Center)
Köhrmann, Martin (Universitaetsklinikum Erlangen)
Katsanos, Aristeidis H. (University General Hospital Attikon (Haidari, Grècia))
Soinne, Lauri (Helsinki University Hospital and Clinical Neurosciences)
Barreto, Andrew D. (University of Texas Health Science Center at Houston)
Rothlisberger, Travis (Cerevast Therapeutics, Inc., Redmond)
Sharma, Vijay K. (Yong Loo Lin School of Medicine)
Mikulik, Robert (St. Anne's University Hospital in Brno)
Muir, Keith W. (University of Glasgow)
Levi, Christopher R. (John Hunter Hospital)
Molina, Carlos A. (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Saqqur, Maher (University of Alberta)
Mavridis, Dimitris (University of Ioannina)
Psaltopoulou, Theodora (Kapodistrian University of Athens)
Vosko, Milan R. (Kepler University Hospital)
Fiebach, Jochen B. (Charité-University Medicine Berlin)
Mandava, Pitchaiah (Baylor College of Medicine)
Kent, Thomas A. (Baylor College of Medicine)
Alexandrov, Andrei V (University of Tennessee Health Science Center)
Schellinger, Peter D. (Ruhr University Bochum)
Universitat Autònoma de Barcelona

Data:	2019
Resum:	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. 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. 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). 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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra, i la creació d'obres derivades, sempre que no sigui amb finalitats comercials i que es distribueixin sota la mateixa llicència que regula l'obra original. Cal que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Endovascular ; Equipoise shift ; Intracranial hemorrhage ; Mechanical thrombectomy ; Outcome ; Recanalization ; Sonothrombolysis ; Stroke ; Ultrasound-enhanced thrombolysis
Publicat a:	Therapeutic Advances in Neurological Disorders, Vol. 12 (july 2019) , ISSN 1756-2864

DOI: 10.1177/1756286419860652
PMID: 31320933

12 p, 545.5 KB

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