Multicenter ambispective observational study of oral anticoagulants in cerebral venous thrombosis (Eurasian Registry of Cerebral Venous Thrombosis — ER-CVT)

Objective. To compare the safety profile of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) in the management of cerebral venous thrombosis (CVT) following initial parenteral therapy. Material and methods. The Eurasian Registry of Cerebral Venous Thrombosis (ER-CVT) is a multicenter, ambispective, comparative cohort study conducted in accordance with the DOAC-CVT protocol. The primary endpoint was the composite of symptomatic venous thromboembolism (VTE) and/or major bleeding, as defined by ISTH criteria, during a 6-month follow-up period. Secondary endpoints included complete recanalization, functional outcomes as assessed by the modified Rankin scale (mRs), and the frequency of changes in anticoagulant therapy over a 12-month follow-up. The dataset was compiled from 12 cities across Russia. Of the total cases, 88 (77%) were recorded retrospectively. Between May 2023 and March 2025, 112 patients diagnosed with CVT from 13 sites In Russia were enrolled in the study. The median age of participants was 41 years (range: 33 to 55 years), with 73 (64%) being female. Brain MRI confirmed the diagnosis of CVT in 81 (72%) cases. Hemorrhagic lesions, as evident in neuroimaging, were observed in 44 (39%) cases. The final analysis of therapeutic efficacy was conducted with 104 patients (92.9% of the initial sample of 112), comprising 72 patients receiving warfarin therapy and 32 receiving DOACs. Results. Following the completion of initial parenteral anticoagulant therapy, 72 patients commenced VKA therapy, and 32 initiated treatment with DOACs. Eight patients who commenced an unspecified oral anticoagulant were excluded from the efficacy analysis. No events of recurrent symptomatic VTE, major bleeding, mortality, clinically significant non-major bleeding, or arterial thromboembolism were reported. In the VKA cohort, 6.9% of patients transitioned to DOACs, whereas no patients in the DOAC group switched to other anticoagulants. Ordinal regression analysis demonstrated significantly increased odds of complete recanalization at 6 and 12 months (OR=60.4; 95% CI 3.1—1191.6, p=0.007, and OR=52.0; 95% CI 2.83—956.3, p=0.008, respectively), as well as improved functional outcomes (as measured by the mRs scale) at 12 months (OR=4.2; 95% CI 1.4—2.5, p=0.012) within the DOAC cohort. Conclusions. The findings from the ER-CVT study indicate a comparably safe profile for both DOACs and VKAs in treating CVT post-initial parenteral therapy. DOACs demonstrated superior recanalization rates and enhanced functional outcomes.