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Rivaroxaban in Chinese children with giant coronary artery aneurysms after Kawasaki disease
Guangan Dai1, Bijue Liu1, Xuecun Liang1
1Pediatric Heart Center, Children's Hospital of Fudan University, Shanghai, People's Republic of China.
Insights
Rivaroxaban is feasible for treating giant coronary artery aneurysms (GCAA) in children post-Kawasaki disease (KD). A modified 15-mg regimen showed no thrombosis or major bleeding in a Chinese pediatric cohort.
Area of Science:
- Pediatric Cardiology
- Pharmacology
- Internal Medicine
Background:
- Limited data exists on rivaroxaban use in children with giant coronary artery aneurysms (GCAA) following Kawasaki disease (KD).
- This study addresses the need for evidence regarding rivaroxaban's efficacy and safety in this specific pediatric population.
Purpose of the Study:
- To evaluate the feasibility of using rivaroxaban in Chinese children diagnosed with GCAA subsequent to KD.
- To assess the safety and efficacy of different rivaroxaban dosing regimens in this cohort.
Main Methods:
- A two-stage study conducted at Children's Hospital of Fudan University involving children aged 1 month to 18 years with persistent GCAA (≥ 8 mm or Z-score ≥ 10).
- Stage 1: 6 patients received a 20-mg-equivalent rivaroxaban regimen. Stage 2: 14 patients received a pharmacometric model-informed 15-mg-equivalent rivaroxaban regimen.
- Follow-up was for at least 6 months, monitoring for GCAA thrombosis, major adverse cardiovascular events, major bleeding, and clinically relevant nonmajor (CRNM) bleeding.
Main Results:
- In Stage 1, no GCAA thrombosis or major bleeding occurred; 4 CRNM bleedings led to dose adjustments. Two patients discontinued treatment due to improved coronary status.
- In Stage 2, the 15-mg-equivalent rivaroxaban regimen showed no primary or secondary outcomes, including GCAA thrombosis, major bleeding, or CRNM bleeding. All patients continued treatment beyond 6 months.
- Pharmacometric model extrapolation was externally validated, supporting predictive performance.
Conclusions:
- A 15-mg-equivalent rivaroxaban regimen appears feasible and safe for Chinese children with GCAA post-KD, with no observed thrombosis or significant bleeding within 6 months.
- Preliminary findings suggest potential efficacy, but larger-scale studies are necessary to confirm these results and establish optimal treatment protocols.
Background:
Data on the use of rivaroxaban in children with giant coronary artery aneurysm (GCAA) after Kawasaki disease (KD) remain limited.
Objectives:
This study evaluated the feasibility of rivaroxaban in Chinese children with GCAA after KD.
Methods:
This study was conducted at the Children's Hospital of Fudan University. Children aged 1 month to 18 years with persistent GCAA (diameter ≥ 8 mm or Z-score ≥ 10) during the postacute period of KD were included and followed up for at least 6 months. The study consisted of 2 stages. During the first stage (January-December 2023), patients received rivaroxaban following the 20-mg-equivalent regimen. In the second stage (January-November 2024), a pharmacometric model-informed rivaroxaban regimen was implemented. The primary outcome was a composite of GCAA thrombosis and major adverse cardiovascular event within 6 months. The secondary outcome included major bleeding and clinically relevant nonmajor (CRNM) bleeding.
Results:
In the first stage, 6 patients were enrolled (median age, 14.6 months; range, 4.7-130.8 months; median weight, 9.9; range, 6.6-33 kg; Z-score, 14.9; range, 10.6-28.0). No primary outcome or major bleeding occurred. Four CRNM bleedings were documented, leading to 6 dose adjustments. Two patients discontinued rivaroxaban due to improved coronary status. In the second stage, 14 patients received the 15-mg-equivalent rivaroxaban regimen (median age, 69.7 months; range, 16.4-143.1 months; median weight, 19.5 kg; range, 12.5-57.5 kg; Z-score, 14.7; range, 10.6-39.1). No primary or secondary outcome occurred. Two patient important bleeding no intervention events were documented. All patients remained on rivaroxaban beyond 6 months. External validation supported the predictive performance of model extrapolation.
Conclusion:
The 15-mg-equivalent rivaroxaban regimen appeared feasible in Chinese children with GCAA after KD, with no GCAA thrombosis, major bleeding or CRNM bleeding observed within 6 months. Larger studies are required to confirm these preliminary findings.
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