Rivaroxaban for pediatric venous thromboembolism in routine clinical practice: Effectiveness and safety from a real-world cohort.
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BACKGROUND: The incidence of pediatric venous thromboembolism (VTE) has been increasing in recent years. Due to the unique hemostatic characteristics of children, thrombi are often difficult to resolve once formed and may result in long-term sequelae. Rivaroxaban has been approved for the treatment of pediatric VTE; however, real-world data on its use in Chinese pediatric populations remain limited. OBJECTIVES: This study aimed to evaluate the effectiveness and long-term safety of rivaroxaban in children with VTE and to provide real-world evidence to support its clinical use. METHODS: This single-center retrospective observational study included children aged >28 days and <18 years who were diagnosed with VTE and received rivaroxaban treatment for at least one month at Beijing Children's Hospital between January 2022 and April 2025. Demographic characteristics, clinical data, and treatment information were collected. Effectiveness outcomes included thrombus resolution and changes in thrombus burden assessed by imaging. Safety outcomes included bleeding events and adverse drug reactions. All patients were followed up for 3 months during treatment, with an additional 3 months of subsequent follow-up. RESULTS: A total of 189 pediatric patients with VTE treated with rivaroxaban were included between January 1, 2022 and April 1, 2025. The median age was 8.6 years, and 53.97% were male. The most common VTE risk factor was pulmonary disease (pneumonia) (58.20%), followed by catheter-related thrombosis (33.33%). At 3-month follow-up, complete thrombus resolution was achieved in 24.34% of patients, partial improvement in 57.67%, and no improvement in 14.29%. Thrombus recurrence occurred in 2.12% of patients, with no fatal VTE or death observed. Univariable logistic regression showed no significant predictors of thrombus recanalization (all P > 0.05). No significant difference in efficacy was found between patients with and without cancer (P = 0.148). For safety, bleeding events were rare and mostly mild (4.79% clinically relevant non-major bleeding), with one discontinuation due to melena and no fatal or intracranial hemorrhage. No significant risk factors for bleeding were identified in univariable analysis. CONCLUSIONS: In this real-world pediatric cohort, rivaroxaban demonstrated favorable effectiveness and an acceptable safety profile, consistent with findings from previous clinical trials. Larger multicenter real-world studies are warranted to further define the clinical value of rivaroxaban in pediatric VTE.