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Use of Rivaroxaban in Children with Congenital Heart Disease: A Single-Center Case Series
Silvestre Duran1, Christina Gerber2, Shannon Bilsky2
1University Hospitals Rainbow Babies and Children's Hospital Pediatric Cardiology, Cleveland, OH, USA. Silvestre.duran@UHhospitals.org.
Insights
Rivaroxaban shows promise for pediatric patients with congenital heart disease (CHD), offering an alternative to warfarin and enoxaparin. This study found it effective for VTE prophylaxis and treatment with manageable bleeding risk in this population.
Area of Science:
- Cardiology
- Pediatric Hematology
- Pharmacology
Background:
- Rivaroxaban is a direct oral anticoagulant with limited study data in pediatric patients with congenital heart disease (CHD).
- Current anticoagulation options for pediatric outpatients, warfarin and enoxaparin, have limitations.
- Rivaroxaban may offer a less burdensome alternative for anticoagulation in pediatric CHD.
Purpose of the Study:
- To describe the single-center experience of using rivaroxaban in pediatric patients with CHD.
- To evaluate the safety and efficacy of rivaroxaban for venous thromboembolism (VTE) prophylaxis and treatment in this population.
Main Methods:
- A retrospective review of 27 pediatric CHD patients initiated on rivaroxaban between May 2020 and July 2022.
- Dosing based on EINSTEIN-Jr and UNIVERSE study protocols.
- Qualitative assessment of safety (bleeding episodes) and efficacy (VTE events/outcomes).
Main Results:
- The study included 27 patients aged 4 months to 15 years; 70% had single ventricle heart disease.
- Fifteen patients (56%) received rivaroxaban for VTE prophylaxis, with no VTE events.
- Twelve patients (44%) received rivaroxaban for VTE treatment, with resolution or no propagation in 10; two experienced clinically relevant bleeding.
Conclusions:
- Rivaroxaban appears to be a potentially effective and manageable option for VTE prophylaxis and treatment in pediatric CHD patients.
- Further larger-scale studies are necessary to confirm safety, efficacy, and optimal indications for rivaroxaban in this specific patient group.
Abstract:
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.
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