- •This study is one of the first studies to explore rivaroxaban in real-world paediatric settings.
- •Results of rivaroxaban use in children less than 2 years (who were under-represented in clinical trials) are promising.
- •Rivaroxaban was effective in treating unusual sites of thrombosis in paediatrics.
- •The current study showed rivaroxaban safety and efficacy in secondary venous thromboembolism prophylaxis in paediatrics.
Paediatric clinical practice for treatment of venous thromboembolism (VTE) is based on extrapolation from adult trials with minimal data on anticoagulation efficacy and safety in children. Based on EINSTEIN-Jr clinical trial data, rivaroxaban was approved to treat VTE and prevent its recurrence in children of all ages.
To report the safety and efficacy of rivaroxaban use in paediatric VTE and to present real-world data, specifically about very young children.
We conducted a retrospective observational study at Birmingham Children's Hospital. Data were collected from patients <16 years old who received rivaroxaban after its licensure in the period between March 2021 and June 2022.
Rivaroxaban was used for treatment of acute VTE in 64 patients. Thrombosis was CVC-related in 26 patients, unprovoked in 3, while the rest had one or more risk factors for VTE. Safety and efficacy of rivaroxaban were assessed in 52 patients after excluding patients who were on current rivaroxaban treatment and those who were lost to follow up or stopped rivaroxaban due to intolerance. No bleeding events were reported, and recurrence of thrombosis occurred in only 3.6 %. About 35 % had normalised re-imaging, 40.3 % improved, 9.6 % were unchanged and 11.5 % stopped rivaroxaban without re-imaging. Rivaroxaban was used for secondary VTE prophylaxis in 6 patients in our cohort with no recurrence of thrombosis or bleeding reports.
Our real-world experience confirmed that rivaroxaban was well tolerated, effective and safe. Further real-world data and observational studies are essential to investigate the use of rivaroxaban among different risk groups.
Abbreviations:CVC (central venous catheter), CVT (cerebral venous thrombosis), DOACs (direct oral anticoagulants), DVT (deep vein thrombosis), IVC (inferior vena cava), LMWH (low molecular weight heparin), PE (pulmonary embolism), RVT (renal vein thrombosis), SVC (superior vena cava), VTE (venous thromboembolism)
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Published online: December 05, 2022
Accepted: November 29, 2022
Received in revised form: November 25, 2022
Received: August 6, 2022
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