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 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.
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Authors | José M Ferro, Jonathan M Coutinho, Olav Jansen, Martin Bendszus, Francesco Dentali, Adam Kobayashi, Bas van der Veen, Corinna Miede, Jorge Caria, Holger Huisman, Hans-Christoph Diener, RE-SPECT CVT Study Group |
Journal | Stroke
(Stroke)
Vol. 51
Issue 11
Pg. 3344-3347
(11 2020)
ISSN: 1524-4628 [Electronic] United States |
PMID | 32972315
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticoagulants
- Antithrombins
- Warfarin
- Dabigatran
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Topics |
- Adult
- Anticoagulants
(therapeutic use)
- Antithrombins
(therapeutic use)
- Arteriovenous Fistula
(diagnostic imaging, epidemiology)
- Central Nervous System Vascular Malformations
(diagnostic imaging, epidemiology)
- Cerebral Angiography
- Cerebral Veins
- Cranial Sinuses
(diagnostic imaging)
- Dabigatran
(therapeutic use)
- Female
- Humans
- Imaging, Three-Dimensional
- Intracranial Thrombosis
(drug therapy, epidemiology)
- Magnetic Resonance Angiography
- Male
- Meningeal Arteries
- Middle Aged
- Randomized Controlled Trials as Topic
- Secondary Prevention
- Sinus Thrombosis, Intracranial
(drug therapy, epidemiology)
- Venous Thrombosis
(drug therapy, epidemiology)
- Warfarin
(therapeutic use)
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