ArticleEClinicalMedicine2026
Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD-CAA prevention (KD-CAAP) trial.
Article in EClinicalMedicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Kawasaki disease (KD) is a childhood vasculitis affecting medium-sized arteries, particularly the coronary arteries. Despite treatment with intravenous immunoglobulin (IVIG), coronary artery aneurysm (CAA) rates remain high in Europe and North America. The KD-CAAP trial evaluated whether adjunctive prednisolone reduces CAA in unselected European children with KD. Methods: This multicentre, randomised, open-label, blinded endpoint-assessed, superiority trial (ISRCTN71987471) enrolled children aged 30 days to 16 years across 59 centres in 12 European countries. Participants were randomised 1:1 to oral prednisolone (2 mg/kg/day) plus IVIG (2 g/kg) and aspirin (experimental group); or IVIG and aspirin (control group), stratified by age (<1 vs ≥1 year), sex and country. Co-primary outcomes were: CAA within 12 weeks and mean maximum coronary artery z-score across weeks 1-6, analysed using intention-to-treat. Findings: Between Jan 2021-July 2024, 103 children (58% male; median age 2 years) were randomised: 50 to experimental and 53 to control groups. All children received IVIG + aspirin; fewer experimental participants received a second IVIG dose [9 (18%) vs 20 (38%) control, p = 0.021] or rescue therapy [8 (16%) vs 17 (32%), respectively, p = 0.044]. CAA occurred in 12/50 (24%) experimental vs 12/53 (23%) control participants (adjusted risk difference +1.1% (95% credibility interval -13.8%-16.1%), with 45% probability of benefit. There was no evidence of difference in mean maximum coronary z-scores over weeks 1-6 (mean 0.6 (95% confidence interval 0.4-0.9) vs 0.7 (0.4-0.9); adjusted difference -0.0; 95% confidence interval -0.2 to +0.2; p = 0.72). CAA developed in 6/12 (50%) infants <1 year. Serious Adverse Events occurred in 7 (14%) experimental vs 3 (6%) control participants (p = 0.19). Costs were significantly lower in the experimental group due to less IVIG use over 12 weeks. Interpretation: Prednisolone reduced treatment escalation, with potential health economic benefits, but did not reduce CAA in unselected European children with KD. CAA rates remained high, particularly in infants. Funding: Innovative Medicines Initiative grant 777389.
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