37 - A MULTI-CENTER, NON-INFERIORITY STUDY TO EVALUATE  THE EFFICACY OF ELIMINATION OF HIGH-DOSE ASPIRIN IN THE ACUTE STAGE OF KAWASAKI DISEASE FOR PREVENTING CORONARY ARTERY LESIONS (KIAA TRIAL)

Background Aspirin and intravenous immunoglobulin (IVIG) are currently the standard treatment of Kawasaki disease for reducing the risk of coronary arteries complications, but the duration and aspirin dosage vary. Many centers reduce the aspirin dosage once the patient is afebrile or do not use high-dose aspirin at all. There has been no multi-center randomized controlled trials to assess the effect of high-dose aspirin in the acute stage of KD.

Methods This trial was designed as a prospective multi-center randomized controlled evaluator-blinded trial with two parallel arms to determine whether IVIG as the primary therapy in the acute stage of KD is as effective on its own compared to IVIG combined with high-dose aspirin therapy. The primary endpoint was defined as a coronary artery lesion (CAL, irregular luminal contour with Z score >2.5 SD) formation at 6-8 weeks. Patients meeting the AHA criteria for KD were randomly assigned (1:1) to a test group (receiving only IVIG, 2 g/kg) or a standard group (receiving IVIG plus high-dose aspirin at 80-100mg/kg/day).

Results This clinical trial (ClinicalTrials.gov Identifier: NCT02951234) was conducted across five medical centers in Linkou Chang Gung Memorial Hospital, Kaohsiung Chang Gung Memorial Hospital, Taichung Veterans General Hospital, Kaohsiung Veterans General Hospital and Tungs' Taichung Metro Harbor Hospital from Taiwan. A total of 152 KD patients were enrolled. After excluding atypical cases, 134 KD patients were processed for analysis; 69 in the standard group and 65 in the test group. In the test group, CAL decreased from 10.8% at the acute phase at the time of KD to 1.5% and 3.1% at 6 weeks and 6 months, respectively. In the standard group, CAL declined from 13.0% to 2.9% and 1.4%. There was no statistically significant difference (P=0.529) in frequency of CAL between the standard and test groups at any point in the study period.

Conclusions This is the first prospective multi-center randomized controlled trial of standard treatment of KD with IVIG plus high-dose aspirin compared with IVIG alone. This study showed that high-dose Aspirin added to IVIG does not reduce the incidence of CAL in patients with Kawasaki disease.