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First published online March 16, 2021

Recanalization after cerebral venous thrombosis. A randomized controlled trial of the safety and efficacy of dabigatran etexilate versus dose-adjusted warfarin in patients with cerebral venous and dural sinus thrombosis

Abstract

Background

The effect of different anticoagulants on recanalization after cerebral venous thrombosis has not been studied in a randomized controlled trial.

Methods

RE-SPECT CVT (ClinicalTrials.gov number: NCT02913326) was a Phase III, prospective, randomized, parallel-group, open-label, multicenter, exploratory trial with blinded endpoint adjudication. Acute cerebral venous thrombosis patients were allocated to dabigatran 150 mg twice daily, or dose-adjusted warfarin, for 24 weeks, after 5–15 days’ treatment with unfractionated or low-molecular-weight heparin. A standardized magnetic resonance protocol including arterial spin labeling, three-dimensional time-of-flight venography, and three-dimensional contrast-enhanced magnetic resonance angiography was obtained at the end of the treatment period. Cerebral venous recanalization at six months was assessed by two blinded adjudicators, using the difference in a score of occluded sinuses and veins (predefined secondary efficacy endpoint) and in the modified Qureshi scale (additional endpoint), between baseline and the end of the treatment.

Results

Of 120 cerebral venous thrombosis patients randomized, venous recanalization could be evaluated in 108 (55 allocated to dabigatran and 53 to warfarin, 1 patient had a missing occlusion score at baseline). No patient worsened in the score of occluded cerebral veins and sinuses, while 33 (60%) on dabigatran and 35 (67%) on warfarin improved. The mean score change from baseline in the occlusion score was similar in the two treatment groups (dabigatran −0.8, SD 0.78; warfarin −1.0, SD 0.92). In the modified Qureshi score, full recanalization was adjudicated in 24 (44%) and 19 (36%), and partial recanalization in 23 (42%) and 26 (49%) patients in the dabigatran and warfarin arms, respectively. No statistically significant treatment difference in the modified Qureshi score could be detected (p = 0.44).

Conclusion

The majority of patients with cerebral venous thrombosis, anticoagulated with either dabigatran or warfarin for six months, showed partial or complete recanalization of occluded sinuses and veins at the end of the treatment.
Clinical trial registration: Trial registry name: ClinicalTrials.gov URL: https://clinicaltrials.gov Registration number: NCT02913326

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References

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International Journal of Stroke

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Published In

Article first published online: March 16, 2021
Issue published: February 2022

Keywords

  1. Cerebral venous thrombosis
  2. dabigatran
  3. MR angiography
  4. recanalization
  5. warfarin

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© 2021 World Stroke Organization.
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History

Manuscript received: January 15, 2021
Manuscript accepted: February 1, 2021
Accepted manuscript online: March 16, 2021
Published online: April 4, 2021
Issue published: February 2022
PubMed: 33724104

Authors

Affiliations

José M Ferro
Department of Neurosciences and Mental Health, Serviço de Neurologia, Hospital Santa Maria, Lisbon, Portugal
Instituto de Medicina Molecular, Universidade de Lisboa, Lisboa, Portugal
Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal
Martin Bendszus
Neurologische Klinik, Abteilung für Neuroradiologie, Universitätsklinikum Heidelberg, Heidelberg, Germany
Olav Jansen
Department of Radiology and Neuroradiology, University of Kiel, Kiel, Germany
Jonathan M Coutinho
Department of Neurology, Amsterdam University Medical Centers, Amsterdam, the Netherlands
Francesco Dentali
Department of Medicine and Surgery, Insubria University, Varese, Italy
Adam Kobayashi
Faculty of Health Sciences and Physical Education, Kazimierz Pulaski University of Technology and Humanities, Radom, Poland
Diana Aguiar de Sousa
Department of Neurosciences and Mental Health, Serviço de Neurologia, Hospital Santa Maria, Lisbon, Portugal
Instituto de Medicina Molecular, Universidade de Lisboa, Lisboa, Portugal
Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal
Lia L Neto
Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal
Serviço de Neuroradiologia, Hospital Santa Maria/Centro Hospitalar Lisboa Norte, Lisboa, Portugal
Corinna Miede
HMS Analytical Software GmbH, Weimar (Lahn), Germany
Jorge Caria
Boehringer Ingelheim International, Ingelheim am Rhein, Germany
Holger Huisman
Boehringer Ingelheim B.V., Alkmaar, the Netherlands
Hans-Christoph Diener
Faculty of Medicine, University Duisburg-Essen, Essen, Germany
on behalf of the RE-SPECT CVT Study Group

Notes

José M Ferro, Faculdade de Medicina, Hospital Santa Maria, Neurology, Universidade de Lisboa, 6th Floor, Avenida Professor Egas Moniz s/n 1649-035 Lisbon, Portugal. Email [email protected]

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