AIM To explore whether the individualized antithrombotic strategy of aspirin based on the platelet function test is superior to the traditional fixed dose regimen in antithrombotic treatment for children with congenital heart disease (CHD).
METHODS A prospective randomized controlled study (registered NO. ChiCTR2000036446) was conducted in our Pediatric Surgery Center. All CHD children less than 6 years old who underwent cardiac surgery and routine antithrombotic therapy with aspirin after surgery from April 2020 to April 2021 were enrolled into this study. The children patients were randomly divided into fixed group 3 mg/(kg·d) and adjustment group according to aspirin dosage. In the adjustment group, the platelet aggregation induced by arachidonic acid (PAG-AA) was measured after 3 and 6 doses of aspirin. For those with PAG-AA>20% after 3 doses, aspirin was added to 6 mg/kg/d from the primary dose of 3 mg/(kg·d). For those PAG-AA still more than 20% after 6 doses, patients were treated with clopidogrel 0.2 mg/(kg·d) plus aspirin 6 mg/(kg·d). The cumulative incidence of thrombotic events including death and the incidence of bleeding events within 3 months after surgery was compared respectively between the two groups.
RESULTS There was no statistically significant difference in the data between the two groups of patients when comparing low aspirin response, thrombotic events, and adverse bleeding events. After receiving the same dose of aspirin 3 mg/(kg·d), once a day for three consecutive doses, there were significant differences in PAG-AA among different individuals. The dose control group improved overall aspirin responsiveness by increasing the dose of aspirin, prolonging the duration of aspirin use, and combining medication, but there was no statistically significant difference compared to the fixed dose group. There were no deaths between the two groups during the follow-up period of 3 months after surgery and at the final follow-up. There was no significant difference in the incidence of thrombotic and bleeding events between the two groups of aspirin responsive patients. Spearman correlation testing showed no significant correlation between low aspirin response and thrombotic events.
CONCLUSION Compared with the fixed dose regimen, aspirin dose adjustment strategy based on the platelet aggregation test is not superior, as it does not significantly reduce the incidence of thrombosis and bleeding events in the early 3 months after surgery in CHD children at high risk of thrombosis. There is no prominent association between low aspirin response and thrombotic events.
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