Comparison of the safety of dabigatran and rivaroxaban in Thai patients: A single-center retrospective study
Keywords:
direct oral anticoagulants, bleeding, dabigatran, rivaroxabanAbstract
Introduction: Direct oral anticoagulants (DOACs), such as dabigatran and rivaroxaban, are commonly used for stroke prevention in atrial fibrillation and venous thromboembolism treatment. However, real-world data on their comparative safety profiles in Thai population is limited.
Objective: The primary objective was to compare the safety outcomes of dabigatran and rivaroxaban in Thai population in real-world use.
Methods: This retrospective cohort study was conducted at Chiangrai Prachanukroh Hospital. The study included patients age over 18 years, diagnosed with AF or VTE, and received either dabigatran or rivaroxaban. Data were collected via electronic medical records from 1 January 2015 to 30 September 2023. Baseline characteristics, bleeding events, and thrombotic outcomes were analyzed.
Results: Total 249 patients were included. The study population’s mean age was 70.5 ± 10.2 years, with 51% being male. The median follow-up time was 17.5 months
(IQR, 11 - 31 months) for both groups. Dabigatran was prescribed more frequently to patients with a history of stroke compared to rivaroxaban (55.0% vs. 16.4%, p < 0.001). Conversely, rivaroxaban was prescribed more often to patients with heart failure (23.1% vs. 13.1%, p = 0.025). The dabigatran group had a higher HAS-BLED and CHA2DS2-VASc scores compared to the rivaroxaban group (1.9 vs. 1.5, p < 0.001, and 3.8 vs 3.2, p = 0.001), respectively. The incidence of major and clinically relevant non-major bleeding was 3.34 and 3.86 per 100 person-years for rivaroxaban and dabigatran, respectively (HR 1.15, 95% CI: 0.44 - 3.04, p = 0.774). No intracranial bleeding was observed in either group.
Conclusion: This study found no significant difference in the risk of major or clinically relevant non-major bleeding between dabigatran and rivaroxaban in Thai population. Further large-scale studies are warranted to confirm these findings and to guide clinical decision-making.
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