Risk of bleeding associated with outpatient use of rivaroxaban in VTE management at a National Referral Hospital in Western Kenya

Abstract

There is limited data on the bleeding safety profile of direct oral anticoagulants, such as rivaroxaban, in low- and middle-income country settings like Kenya. In this prospective observational study, patients newly started on rivaroxaban or switchingto rivaroxaban from warfarin for the management of venous thromboembolism (VTE) within the national referral hospital inwestern Kenya were assessed to determine the frequency of bleeding during treatment. Bleeding events were assessed at the1- and 3-month visits, as well as at the end of follow-up. The International Society of Thrombosis and Hemostasis (ISTH) andthe Bleeding Academic Research Consortium (BARC) criteria were used to categorize the bleeding events, and descriptivestatistics were used to summarize categorical variables. Univariate and multivariate logistic regression model was used to cal-culate unadjusted and adjusted associations between patient characteristics and bleeding. The frequency of any type of bleed-ing was 14.4% (95% CI: 9.3%-20.8%) for an incidence rate of 30.9 bleeding events (95% CI: 20.1-45.6) per 100 patient-years offollow-up. The frequency of major bleeding was 1.9% while that of clinically relevant non-major bleeding was 13.8%. In themultivariate logistic regression model, being a beneficiary of the national insurance plan was associated with a lower risk ofbleeding, while being unemployed was associated with a higher bleeding risk. The use of rivaroxaban in the management ofVTE was associated with a higher frequency of bleeding. These findings warrant confirmation in larger and more targetedinvestigations in a similar population.