IVIG Alone Is as Effective as IVIG Plus Aspirin in Kawasaki Disease: JAMA
Researchers have discovered in a new study that high-dose aspirin does not significantly enhance coronary artery outcomes in children with Kawasaki disease (KD) when it is added to routine IVIG therapy. The study found IVIG alone to be noninferior to the combination of IVIG and high-dose aspirin for the prevention of coronary artery lesions (CALs) in affected children. These data contradict the long-standing tradition of incorporating high-dose aspirin in initial treatment and indicate that IVIG alone is enough for acute-phase therapy in KD. The study was conducted by Ho-Chang and colleagues published in JAMA Network Open.
Kawasaki disease is a self-limited inflammatory disease that mainly occurs in children less than 5 years old and is the major cause of acquired cardiovascular disease in children. Standard therapy has traditionally incorporated IVIG with high-dose aspirin in an effort to minimize the risk of coronary artery lesions. Researchers performed a prospective, multicenter, evaluator-blinded, noninferiority trial to compare the outcomes of IVIG alone with IVIG plus high-dose aspirin in children with KD.
The trial was performed in five large medical centers in Taiwan. 134 children less than 6 years of age, diagnosed by the American Heart Association criteria of KD, were recruited from September 2016 to August 2018. Participants were equally divided into two treatment arms: one received IVIG alone (2 g/kg), and the other received IVIG (2 g/kg) with high-dose aspirin (80–100 mg/kg per day) until fever had remitted for a period of at least 48 hours.
Follow-up assessment was conducted at 6 weeks and 6 months after treatment. The researchers assessed the progression of coronary artery lesions as the main outcome measure using the noninferiority margin of 10%. More sophisticated statistical analysis, such as the chi-square tests and repeated measures analysis, were employed for strong data interpretation.
Key Findings
• The last sample consisted of 134 patients, with a mean age of 1.8 years (SD 1.3 years), and 82 (61.2%) were male. The two treatment groups were comparable regarding age, weight, height, and sex distribution.
In the IVIG plus aspirin group (69 patients):
• CALs were present in 9 children (13.0%) at baseline.
• CALs decreased to 2 children (2.9%) at 6 weeks.
• CALs decreased further to 1 child (1.4%) at 6 months.
In IVIG-only cohort (65 children):
• CALs were noted in 7 children (10.8%) at diagnosis.
• CALs decreased to 1 child (1.5%) at 6 weeks.
• CALs increased marginally to 2 children (3.1%) at 6 months.
• There was no statistically significant difference in the incidence of coronary artery lesions between the two cohorts at any of the time points. The 6-week difference in occurrence of CAL in the groups was only 0.7 percentage points (95% CI, –4.5 to 5.8; p=0.65), safely within the noninferiority margin set a priori at 10%.
• Furthermore, no clinically relevant differences in prophylactic or treatment effects were seen, supporting the conclusion that high-dose aspirin was not providing added clinical benefit here.
The study authors concluded that IVIG monotherapy is similar in effect to IVIG plus high-dose aspirin for prevention of coronary artery lesions in pediatric Kawasaki disease. The research emphasizes that the addition of high-dose aspirin is not associated with clinically significant benefit within initial therapy.
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