Use of Rivaroxaban in Children with Congenital Heart Disease: A Single-Center Case Series

Rivaroxaban is a direct oral anticoagulant approved for therapeutic and prophylactic anticoagulation in both adults and children. Studies on rivaroxaban use in pediatric patients with congenital heart disease (CHD) are limited. Currently, warfarin (oral) and enoxaparin (injection) are the primary options for pediatric outpatient anticoagulation. Rivaroxaban may be a less burdensome alternative, but its use has not been well described in the pediatric CHD population. We describe our single-center experience. From May 2020-July 2022, we identified all pediatric CHD patients started on rivaroxaban. Dosing was based on recommendations reported in the EINSTEIN-Jr (Male et al. in Lancet Haematol 7:e18-e27, 2020) and UNIVERSE study (McCrindle et al. in J Am Heart Assoc 10:e021765, 2021) protocols. Qualitative outcomes on safety and efficacy are reported. There were 27 patients studied with an age range of 4 months-15 years at time of medication initiation. Single ventricle heart disease was present in 70% (19/27) of patients. Of the 27 patients initiated on rivaroxaban, 15 (56%) were started for VTE prophylaxis and 12 (44%) were started for VTE treatment. No patients started on rivaroxaban for prophylaxis developed a VTE. There was resolution or lack of propagation in 10 of the 12 patients started for treatment. There were two clinically relevant bleeding episodes. Our single-center case series describes the experience with rivaroxaban for VTE prophylaxis and treatment in pediatric congenital heart disease. Larger studies are required to further investigate safety, efficacy, and use indications.