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

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.