Research and practice in thrombosis and haemostasis · 2025
Rivaroxaban in Chinese children with giant coronary artery aneurysms after Kawasaki disease.
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Dai Guangan, Liu Bijue, Liang Xuecun, Lin Yixiang, He Lan, Wang Feng, He Qingfeng, Zhao Quming, Zhao Lu, Zheng Yuanzheng, Chu Chen, Sun Shuna, Brandão Leonardo R, Huang Guoying, Zhu Xiao, Liu Fang
Аннотация
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.
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.