Long-Term Safety, Efficacy, and Outcomes Following Treatment with Dabigatran as First-Line Treatment in Subjects with Cerebral Venous Sinus Thrombosis (CVST): A Clinical Study

Abstract

Background: Dabigatran is a drug given orally having renal clearance primarily, and is equally efficient anticoagulant as Warfarin with the additive advantage of less bleeding risk compared to warfarin making it a promising anticoagulant with efficacy and safety in CVST subjects.
Aims: To assess the long-term safety, efficacy, and outcomes following treatment with Dabigatran as first-line treatment in subjects with Cerebral Venous Sinus Thrombosis (CVST).Materials and Methods: In 70 subjects with CVST, LMWH (Low Molecular Weight Heparin) was given for 5 days starting at the day of admission after confirmed diagnosis. The subjects were then started on 110 mg capsule of Dabigatran from day 3 for 3 months twice daily. The treatment outcomes were evaluated after 3 months using an MRI venogram. The collected data were subjected to statistical evaluation and the results were formulated.Results: Total deaths reported at 3 months were 7.46% (n=5) in subjects having GCS <8. 19.35% (n=12) of subjects survived after 3 months of Dabigatran use with a GCS score of <8 with small infarct, whereas, 80.64% (n=50) subjects with GCS >8 and either small lesion or non-haemorrhagic lesion also survived. Recanalization was seen in all 62 subjects at follow-up. Conclusion: The present study concludes that the recanalization in patients with CVST is quite early with the use of Dabigatran for 3 months after Cerebral venous sinus thrombosis event with very few adverse events.