Rivaroxaban in Paediatric Patients Beyond Clinical Trial Settings - A Real-World Retrospective Cohort Study.
Rivaroxaban led to thrombus resolution in over half of treated children
Rivaroxaban in Paediatric Patients Beyond Clinical Trial Settings - A Real-World Retrospective Cohort Study.
ABSTRACT: BACKGROUND: Direct oral anticoagulants (direct oral anticoagulants) show increasing popularity in the treatment of paediatric venous thromboembolism (venous thromboembolism), but real-world evidence outside clinical trials remains scarce.
ABSTRACT: OBJECTIVES: This study aimed to evaluate the use, safety and effectiveness of rivaroxaban in a real-world paediatric cohort at a tertiary care hospital.
ABSTRACT: METHODS: All children exposed to rivaroxaban between January 2020 and June 2025 at our institution were included into this single-centre retrospective cohort study.
In the prophylaxis group ( n = 20), no incident venous thromboembolism occurred.
Overall, clinically relevant bleeding was rare (7%), all non-major during rivaroxaban exposure and occurred exclusively in children with identifiable additional bleeding risk factors.
Rivaroxaban demonstrated a favourable effectiveness and safety profile in this real-world paediatric cohort, with outcomes comparable to available real-world and trial data.
clinically relevant bleeding events clustered in settings with additional bleeding risks, underscoring the importance of patient characteristics in guiding therapy.
Our findings support rivaroxaban as a feasible anticoagulation option in children.