Introduction: Kawasaki disease (KD) is generally treated with IVIG+high anti-inflammatory doses of Aspirin, which is subsequently switched to low, anti-thrombotic dose. We aimed to compare the efficacy and safety of IVIG+ high dose Aspirin regimen with IVIG+low dose Aspirin in a multicenter, national, retrospective study.
Methods: Medical records review of KD patients from our Pediatric Rheumatology Study Group units (8 hospitals) was conducted. The primary efficacy outcome was defined as coronary aneurism 2-4 weeks after fever onset. Groups were compared using the Student`s t-test for continuous variables and the Pearson Chi-square test for categorical variables.
Results: 303 KD patients, 262 in the high dose and 41 in the low dose group were included. There were no demographic, clinical, or laboratory differences between the groups. In the high dose group, 8.4% had coronary aneurisms, compared to 5.3% in the low dose group (P=0.64). Regarding mild coronary findings, 24.2% of the high dose group developed coronary ectasia 2-4 weeks after KD onset, compared to 4.3% in the low dose group (p=0.03). No significant statistical differences were noted between the groups in time until fever resolution in days. The number of adverse events in both groups was similar (P=0.94).
Conclusion: The efficacy and safety of treatment with IVIG and low-dose Aspirin was similar to that of IVIG and high dose Aspirin in patients with KD. We suggest that the routine use of high-dose Aspirin+IVIG, will be re-evaluated in further prospective controlled studies.