Safety of direct oral anticoagulants in hemodialysis patients with venous thromboembolism: an analysis using the Korean National Health Insurance Service database.

Background: Limited data exist regarding the safety of direct oral anticoagulants in hemodialysis patients with venous thromboembolic disease. This study aims to investigate the safety of direct oral anticoagulants in hemodialysis patients using national data.

Methods: The National Health Insurance Service database was retrospectively queried to identify chronic kidney disease patients who took direct oral anticoagulants for venous thromboembolism from 2008 to 2019. Bleeding complications and all-cause mortality were compared between 118 hemodialysis patients (HD group) and 227 matched chronic kidney disease patients not undergoing hemodialysis (CKD group).

Results: The use of direct oral anticoagulants among chronic kidney disease patients, with or without dialysis, increased over time. The incidence rate of all-cause mortality per 100 person-years was 38.1 in the HD group and 10.5 in the CKD group (adjusted hazard ratio [HR], 3.28; 95% confidence interval [CI], 2.27-4.75; p < 0.001). When considering death as a competing risk, there was no significant difference in gastrointestinal bleeding (adjusted HR, 1.61; 95% CI, 0.91-2.88; p = 0.115) and intracranial bleeding (adjusted HR, 1.86; 95% CI, 0.73-4.74; p = 0.193) between the HD and CKD groups.

Conclusion: In comparison to chronic kidney disease patients not on hemodialysis, the major bleeding risk, including gastrointestinal and intracranial bleeding, was comparable in hemodialysis patients using direct oral anticoagulants for venous thromboembolism.