Safety of DOACs in Budd-Chiari syndrome: A real-world comparison from the TriNetX Global Collaborative Network.

Abstract

e23289 Background: Anticoagulation is the cornerstone treatment for all types of Budd-Chiari Syndrome (BCS), often requiring lifelong therapy. While heparin and Coumadin have traditionally been the primary treatments, Coumadin carries a significant bleeding risk, highlighting the need for more tailored strategies. Recently, direct oral anticoagulants (DOACs) have emerged as a potential alternative. Though off-label for BCS, the limited existing literature on their safety and efficacy is based on small studies, indicating the need for further research. Methods: This study used the TriNetX database, a multicenter platform encompassing over 270 million patients from 120 healthcare organizations globally. The dataset included adults (≥18 years) diagnosed with BCS who received anticoagulation therapy with Coumadin or DOACs between 2006 and 2024. Exclusion criteria included other systemic thrombosis, end-stage renal disease (ESRD), pregnancy, platelet counts < 50×10³/μL, or malignant neoplasms of the liver or biliary system. Two cohorts were created: patients initiating coumadin and those starting DOACs within two weeks of BCS diagnosis. Propensity score matching (PSM) adjusted for confounders such as gender, ethnicity, antiplatelet use, smoking, and chronic diseases, creating well-matched groups. TriNetX's statistical tools compared one-year and two-years outcomes, including major bleeding, transjugular intrahepatic portosystemic shunt (TIPS) procedures, spontaneous bacterial peritonitis (SBP), and mortality. Results: A total of 15,245 patients diagnosed with BCS were identified, of whom 2,566 were treated with Coumadin and 3,066 with any DOACs. PSM was used to create two balanced cohorts of 381 patients each. At the one-year follow-up, the rate of major bleeding in patients treated with Coumadin compared to those treated with DOACs was 9.7% vs. 7.6% (P = 0.30). The rates of TIPS procedures (3.7% vs. 3.7%) and SBP (3.4% vs. 2.6%, P = 0.53) were similar between the groups. Similarly, overall mortality rates were higher in the Coumadin group but not statistically significant (11.0% vs. 8.4%, P = 0.22). At the two-year follow-up, major bleeding rates remained higher in the Coumadin group, although the difference was not statistically significant (11.7% vs. 9.0%, P = 0.23). The rates of TIPS procedures (3.4% vs. 4.8%, P = 0.36) and SBP (3.4% vs. 2.7%, P = 0.52) continued to show no significant differences between the groups. Conclusions: This study found that DOACs were comparable in safety and effectiveness to Coumadin for BCS patients. While Coumadin-treated patients had slightly higher rates of major bleeding and mortality at one- and two-year follow-ups, the differences were not statistically significant. Rates of TIPS procedures and SBP were similar between groups. These findings support DOACs as a potential alternative to Coumadin.