Rivaroxaban in Paediatric Patients beyond Clinical Trial Settings – A Real-World Retrospective Cohort Study

Introduction Direct oral anticoagulants show increasing popularity in the treatment of paediatric venous thromboembolism (VTE), but real-world evidence outside clinical trials remains scarce. In Switzerland, rivaroxaban has been licensed for use of VTE treatment in children. This study aimed to evaluate the indications of use, effectiveness and safety of rivaroxaban in a real-world paediatric cohort at a tertiary care centre. Method Children exposed to rivaroxaban from 01/2020 to 06/2025 were included into this single-centre retrospective cohort study. Baseline demographic characteristics and anticoagulation indication were systematically extracted from medical records. Treatment effectiveness was assessed as thrombus recurrence, progression, improvement, and resolution, while primary prophylaxis effectiveness was defined as occurrence of any VTE. Safety outcomes included clinically relevant bleeding (CRB – defined as major bleeding and/or non-major CRB). All outcomes were defined according to ISTH trial criteria. A descriptive statistical analysis was conducted. The Cantonal Ethics Board approved this study [ 1 ] [ 2 ] [ 3 ]. Results Fifty-seven children (49% female) were included at a median age of 13.8 years (P25-75, 7.1-15.6) for a total follow-up duration of 70.96 years. Patient demographics are shown in [ Fig. 1 ]. Rivaroxaban was administered for VTE treatment in 32, for secondary VTE-prevention in 3, for primary prophylaxis in 20, and for other indications in 2 children (stroke, livedoid vasculopathy). Fig. 1 Demographics n (%); median (P25-P75) VTE (venous thromboembolic events) Of all VTEs in the treatment group (VTE-treatment and secondary VTE-prevention; n=35), 41% were catheter-related, with high predominance in the children aged