Intravenous Immunoglobulin Alone for Coronary Artery Lesion Treatment of Kawasaki Disease: A Randomized Clinical Trial
Authors' conclusion
This randomized clinical trial demonstrated the noninferiority of IVIG alone compared with IVIG plus aspirin, with a noninferiority margin set at 10%.
Study context
- Population
- Children (aged <6 years) with Kawasaki disease (KD) by American Heart Association criteria, 5 medical centers in Taiwan, 2016–2018
- Participants
- 134 children
- Comparison
- Intravenous immunoglobulin (IVIG) alone vs IVIG plus high-dose aspirin
- IVIG-onlyn = 65
- IVIG plus aspirinn = 69reference
- Primary endpoint
- Occurrence of coronary artery lesions (CALs) at 6 weeks
- Follow-up
- 6 weeks
Methodological detailsprospective, evaluator-blinded, multicenter, noninferiority
- Prospective
- Evaluator-blinded
- Multicenter
- Noninferiority
Primary result
As reported in the abstract
Occurrence of CALs
Further findings
CAL occurrence · 6 months
Treatment or prophylactic effect
- No significant differences in the treatment or prophylactic effect
Original publication
Intravenous Immunoglobulin Alone for Coronary Artery Lesion Treatment of Kawasaki Disease: A Randomized Clinical Trial. JAMA Netw Open. Published 1 April 2025. doi:10.
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