دورية أكاديمية
Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
| العنوان: | Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke |
|---|---|
| المؤلفون: | Alexandrov, Andrei V., Tsivgoulis, Georgios, Köhrmann, 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. |
| سنة النشر: | 2019 |
| المجموعة: | OPUS FAU - Online publication system of Friedrich-Alexander-Universität Erlangen-Nürnberg |
| مصطلحات موضوعية: | ddc:610 |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://opus4.kobv.de/opus4-fau/frontdoor/index/index/docId/16296Test; urn:nbn:de:bvb:29-opus4-162962; https://nbn-resolving.org/urn:nbn:de:bvb:29-opus4-162962Test; https://doi.org/10.1177Test/ 1756286419860652; https://opus4.kobv.de/opus4-fau/files/16296/1756286419860652.pdfTest |
| DOI: | 10.1177/ |
| الإتاحة: | https://opus4.kobv.de/opus4-fau/frontdoor/index/index/docId/16296Test https://nbn-resolving.org/urn:nbn:de:bvb:29-opus4-162962Test https://opus4.kobv.de/opus4-fau/files/16296/1756286419860652.pdfTest |
| حقوق: | https://creativecommons.org/licenses/by/4.0/deed.deTest ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.123B55C2 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1177/ |
|---|