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

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 s...

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Detalles Bibliográficos
Autores: Alexandrov, Andrei V.|||0000-0001-8871-1023, Tsivgoulis, Georgios|||0000-0002-0640-3797, Köhrmann, Martin, Katsanos, Aristeidis H.|||0000-0002-6359-0023, Soinne, Lauri, Barreto, Andrew D., Rothlisberger, Travis, Sharma, Vijay K., Mikulik, Robert, Muir, Keith W., Levi, Christopher R., Molina, Carlos A.|||0000-0001-6058-6259, Saqqur, Maher, Mavridis, Dimitris|||0000-0003-1041-4592, Psaltopoulou, Theodora, Vosko, Milan R., Fiebach, Jochen B., Mandava, Pitchaiah, Kent, Thomas A., Schellinger, Peter D.
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:226546
Acceso en línea:https://ddd.uab.cat/record/226546
https://dx.doi.org/urn:doi:10.1177/1756286419860652
Access Level:acceso abierto
Palabra clave:Endovascular
Equipoise shift
Intracranial hemorrhage
Mechanical thrombectomy
Outcome
Recanalization
Sonothrombolysis
Stroke
Ultrasound-enhanced thrombolysis
Descripción
Sumario: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.

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