Quick Take: Safety and Efficacy of Dabigatran Etexilate vs Dose-Adjusted Warfarin in Patients with Cerebral Venous Thrombosis

Central venous thrombosis (CVT) is a form of stroke characterized by thrombosis of cerebral veins or dural sinuses. While less than 5% of the 1.3 to 1.6 per 100,000 who experience CVT die by this cause, those who survive are at an increased risk of venous thrombotic events, and therefore, require anticoagulation, traditionally warfarin. The use of non-vitamin K oral anticoagulants in this setting has not been evaluated in randomized trials. In this multicentre randomized clinical trial (RE-SPECT CVT), 120 patients with CVT were randomized to receive dabigatran 150 mg twice daily or dose-adjusted warfarin for a treatment period of 24 weeks to assess the efficacy and safety of dabigatran in preventing recurrent VTEs in this patient population. Researchers found that while no recurrent VTEs were noted during the study, one major intestinal bleeding event occurred in the dabigatran group (1.7%, 95% CI 0.0% to 8.9%) and two major intracranial bleeding events occurred in the warfarin group (3.3% 95% CI 0.4% to 11.5%). An additional participant in the warfarin group experienced a non-major, clinically relevant bleeding event. Recanalization occurred in 60% of patients from the dabigatran group (95% CI 45.9% to 73.0%) and 67.3% of the warfarin group (95% CI 52.9% to 79.7%). The findings of this study demonstrate that patients who had CVT anticoagulated with either dabigatran or warfarin had a low risk of recurrent VTEs. Risks of bleeding events were also low and similar between medication groups, suggesting comparable safety with either approach in CVT patients at risk for recurrent VTEs.

Click to read the study in JAMA Neurology

Image: PD

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