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Rivaroxaban in Paediatric Patients Beyond Clinical Trial Settings - A Real-World Retrospective Cohort Study
Lukas Röthlisberger1,2, Manuela Albisetti1, Alessandra Bosch1
1University Children's Hospital Zürich, Department of Haematology, ZH, Switzerland, Zürich.
Hamostaseologie
|July 29, 2026
Summary
Rivaroxaban is a safe and effective treatment for paediatric venous thromboembolism (VTE) in real-world settings. This study found favourable outcomes comparable to clinical trials, with bleeding events primarily in high-risk patients.
Area of Science:
- Pediatric Hematology
- Pharmacology
- Clinical Thrombosis
Background:
- Direct oral anticoagulants (DOACs) are increasingly used for pediatric venous thromboembolism (VTE).
- Real-world data on DOAC use in children is limited.
- Rivaroxaban is a commonly prescribed DOAC.
Purpose of the Study:
- To evaluate the real-world use, safety, and effectiveness of rivaroxaban in children.
- To assess treatment outcomes and bleeding events in a pediatric cohort.
- To compare findings with existing clinical trial and real-world data.
Main Methods:
- Single-center retrospective cohort study.
- Inclusion of children exposed to rivaroxaban from January 2020 to June 2025.
- Assessment of effectiveness (thrombus recurrence, progression, resolution) and safety (clinically relevant bleeding, minor bleeding).
Main Results:
- Fifty-seven children were analyzed (median age 13.8 years).
- Low recurrence rate (3%) in the treatment group; no VTE in the prophylaxis group.
- Clinically relevant bleeding (CRB) was rare (7%) and non-major, occurring in patients with additional bleeding risk factors.
Conclusions:
- Rivaroxaban shows a favorable safety and effectiveness profile in pediatric VTE management.
- Outcomes are comparable to existing data, supporting its use.
- Patient-specific bleeding risks are crucial for guiding rivaroxaban therapy in children.
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