Bleeding and Thrombotic Outcomes in Patients With Inflammatory Bowel Disease and Venous Thromboembolism Open Access

• Patients with inflammatory bowel disease [IBD] are at an increased risk of venous thromboembolism [VTE] and bleeding.

• DOAC use was associated with a lower risk of bleeding compared to warfarin, without a significant difference in the risk of recurrent VTE.

Patients with inflammatory bowel disease [IBD] are at an increased risk of venous thromboembolism [VTE] and bleeding. While oral anticoagulants are effective in preventing VTE recurrence, concerns exist regarding the risk of bleeding complications in the context of IBD.nWe conducted a target trial emulation in patients with IBD and VTE to compare the risk of recurrent VTE and serious bleeding between direct oral anticoagulants [DOACs] and warfarin. This was a retrospective cohort study using a U.S.-based commercial healthcare insurance database from 1 January 2015 to 31 December 2022. The study included adults with IBD and VTE who were newly prescribed DOACs or warfarin. The primary study outcomes were recurrent VTE and a composite of serious bleeding events leading to hospitalization. We used Cox proportional hazard model after propensity score matching to estimate the hazard ratios [HRs] and 95% confidence intervals [CIs]. In a secondary analysis, we compared the risk of bleeding in patients on DOACs with IBD vs. non-IBD patients. Our matched IBD cohort patients initiating oral anticoagulants comprised 2174 patients (1087 DOAC users and 1087 warfarin users). The median follow-up duration was 107 days (IQR, 46 and 225 days) for DOAC users, compared to 110 days (IQR, 42 and 250 days) for warfarin users. After propensity score matching, DOAC use (compared to warfarin) was associated with a lower risk of bleeding (HR, 0.59 [95% CI, 0.41 to 0.85]) with no difference in the risk of recurrent VTE (HR, 0.82 [95% CI, 0.59 to 1.15]). In the secondary analysis of patients with VTE who were users of DOACs, there was a 2-fold increase in the risk of bleeding in patients with IBD compared to non-IBD patients (HR, 1.99 [95% CI, 1.64 to 2.41]). In patients with IBD and VTE, DOAC use was associated with a lower risk of bleeding compared to warfarin, without a significant difference in the risk of recurrent VTE. However, even with the use of DOACs, patients with IBD were twice as likely to experience serious bleeding as those without IBD, highlighting the importance of close monitoring.