Safety and Efficacy of Dabigatran vs Dose Adjusted Warfarin inPatients with Cerebral Venous thrombosis”

Abstract

Background:Patients with cerebral venous thrombosis (CVT) are at risk of recurrent venousthrombotic events (VTEs). Non–vitamin K oral anticoagulants which are relatively safer have not been evaluated in cerebral venous thrombosis.

 Objectiveof the study: To compare the efficacy and safety of dabigatran with those of dose-adjusted warfarin in preventing recurrent VTEs among patients with history of CVT.

 Material & Methods: This was a longitudinal, prospective, observational single center study with two parallel treatment groups. The study period was September 2018 to March, 2021 and was conducted at Sher- e- Kashmir Institute of Medical Sciences Soura. Adult patients with acute CVT, who were stable after 5 to 15 days of treatment with subcutaneous heparin, were screened for eligibility. Patients with CVT associated with pregnancy or major trauma were excluded, but those with intracranial hemorrhage from index CVT were allowed to participate. A total of 82 patients were recruited for the study and were divided into two treatment groups based on the initial treatment they had received.Dabigatran, 150 mg twice daily, or dose-adjusted warfarin for a treatment period of 24 weeks were given to the recruited patients. Outcome was measured based on the following criteria. The primary outcome was a composite of patients with a new VTE (recurrent CVT, deep vein thrombosis of any limb, pulmonary embolism, and major bleeding during the study period. Secondary outcomes were cerebral venous recanalization and clinically relevant non–major bleeding events. Patient Data was entered in Microsoft Excel spreadsheet 2007 and analysed using SPSS V.26.0.

Results: A total of 82 patients with CVT were recruited for the study after explaining the objectives of the study and were divided into two treatment groups (42 to dabigatran and 40 to dose-adjusted warfarin) based on the drug they were prescribed by their treating neurologist. Of the two treatment groups, the mean (SD) age was 34.4 (12.5) years, and 61 (68.02%) were women. The mean (SD) duration of exposure was 23.3 (6.16) weeks for the dabigatran group and 23.0 (5.20) weeks for the warfarin group. Two recurrent VTEs were observed. One (1.7%; 95% CI, 0.0-8.9) major bleeding event (hematuria) was recorded in the dabigatran group, and 2 (3.3%; 95% CI,0.4-11.5) (intracranial) in the warfarin group. One additional patient (1.7; 95% CI, 0.0-8.9) in the warfarin group experienced a clinically relevant non–major bleeding event. Recanalization occurred in 40 patients in the dabigatran group (95.2.0%; 95% CI, 45.9-73.0) and in 36 patients in the warfarin group (90%; 95% CI, 52.9-79.7).

Conclusion:This study found that patients who had CVT anticoagulated with either dabigatran or warfarin had low risk of recurrent VTEs, and the risk of bleeding was similar with both medications, suggesting that both dabigatran and warfarin may be safe and effective for preventing recurrent VTEs in patients with CVT. However long-term treatment compliance and associated cognitive abnormalities were better with dabigrtan.