José M Ferro1, Jonathan M Coutinho2, Olav Jansen3, Martin Bendszus4, Francesco Dentali5, Adam Kobayashi6, Bas van der Veen2, Corinna Miede7, Jorge Caria8, Holger Huisman9, Hans-Christoph Diener10. 1. Serviço de Neurologia, Department of Neurosciences and Mental Health, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Portugal (J.M.F.). 2. Department of Neurology, Amsterdam University Medical Centers, the Netherlands (J.M.C., B.v.d.V.). 3. Department of Radiology and Neuroradiology, University of Kiel, Germany (O.J.). 4. Neurologische Klinik, Abteilung für Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany (M.B.). 5. Department of Medicine and Surgery, Insubria University, Varese, Italy (F.D.). 6. Faculty of Health Sciences and Physical Education, Kazimierz Pulaski University of Technology and Humanities, Radom, Poland (A.K.). 7. HMS Analytical Software GmbH, Weimar (Lahn), Germany (C.M.). 8. Boehringer Ingelheim International, Ingelheim am Rhein, Germany (J.C.). 9. Boehringer Ingelheim B.V., Alkmaar, the Netherlands (H.H.). 10. Faculty of Medicine, University Duisburg-Essen, Germany (H.-C.D.).
Abstract
BACKGROUND AND PURPOSE: This analysis examined the frequency of dural arteriovenous fistulae (dAVF) after cerebral venous thrombosis (CVT) in patients included in a randomized controlled trial comparing dabigatran etexilate with dose-adjusted warfarin (RE-SPECT CVT [A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis]), who had systematic follow-up magnetic resonance (MR) imaging. METHODS: RE-SPECT CVT was a Phase 3, prospective, randomized, parallel-group, open-label, multicenter, exploratory trial with blinded end point adjudication. We allocated patients with acute CVT to dabigatran 150 mg twice daily or dose-adjusted warfarin, for 24 weeks and obtained a standardized MR protocol including time-of-flight MR angiography, 3-dimensional phase-contrast venography, and 3-dimensional contrast-enhanced MR venography at the end of the treatment period. A blinded adjudication committee assessed the presence of dAVF in a predefined substudy of the trial. RESULTS: We analyzed development of dAVF in 112 of 120 randomized patients; 57 allocated todabigatran and 55 to warfarin. For 3 (2.7%) of these 112 patients, quality of follow-up imaging was insufficient to evaluate dAVF. A dAVF (Borden I) was found in 1 patient (0.9%) allocated to warfarin; however, this dAVF was already present at baseline. The patient did not present with hemorrhage at baseline or during the trial and was asymptomatic at follow-up. CONCLUSIONS: Despite systematic imaging, we found no new dAVF 6 months after CVT. Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02913326.
RCT Entities:
BACKGROUND AND PURPOSE: This analysis examined the frequency of dural arteriovenous fistulae (dAVF) after cerebral venous thrombosis (CVT) in patients included in a randomized controlled trial comparing dabigatran etexilate with dose-adjusted warfarin (RE-SPECT CVT [A Clinical Trial Comparing Efficacy and Safety of Dabigatran Etexilate With Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis]), who had systematic follow-up magnetic resonance (MR) imaging. METHODS: RE-SPECT CVT was a Phase 3, prospective, randomized, parallel-group, open-label, multicenter, exploratory trial with blinded end point adjudication. We allocated patients with acute CVT to dabigatran 150 mg twice daily or dose-adjusted warfarin, for 24 weeks and obtained a standardized MR protocol including time-of-flight MR angiography, 3-dimensional phase-contrast venography, and 3-dimensional contrast-enhanced MR venography at the end of the treatment period. A blinded adjudication committee assessed the presence of dAVF in a predefined substudy of the trial. RESULTS: We analyzed development of dAVF in 112 of 120 randomized patients; 57 allocated to dabigatran and 55 to warfarin. For 3 (2.7%) of these 112 patients, quality of follow-up imaging was insufficient to evaluate dAVF. A dAVF (Borden I) was found in 1 patient (0.9%) allocated to warfarin; however, this dAVF was already present at baseline. The patient did not present with hemorrhage at baseline or during the trial and was asymptomatic at follow-up. CONCLUSIONS: Despite systematic imaging, we found no new dAVF 6 months after CVT. Routine follow-up cerebral MR angiography aiming to detect new dAVF 6 months after CVT has a very low yield. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02913326.
Authors: Gauruv Bose; Justin Graveline; Vignan Yogendrakumar; Risa Shorr; Dean A Fergusson; Gregoire Le Gal; Jonathan Coutinho; Marcelo Mendonça; Miguel Viana-Baptista; Simon Nagel; Dar Dowlatshahi Journal: BMJ Open Date: 2021-02-16 Impact factor: 2.692