Safety of Apixaban on pediatric heart disease on the prevention of embolism
People with certain types of heart disease may need to take medication to prevent their blood from clotting. That medication is called an anticoagulant or a blood thinner. The purpose of this study was to find out whether the medicine called apixaban (commonly known as Eliquis®) is safe for children with heart disease, and to learn how much apixaban will be present in the blood after taking a certain dose. Researchers compared apixaban to two other widely used blood thinners in children with congenital or acquired heart disease.
with heart disease who needed to take medication to prevent blood clots
Bleeding and thromboembolism were infrequent in both treatment groups.
Results support the use of apixaban as an alternative for thromboprophylaxis in pediatric heart disease.
From 2017 to 2021, 192 participants ages 28 days to 17 years with congenital or acquired heart disease who needed to take medication to prevent blood clots were enrolled and randomized.
Participation lasted for up to 14 months, or until anticoagulation was no longer needed. The study consisted of:
One apixaban participant (0.8%) and 3 with other standard treatments (4.8%) had major or clinically relevant nonmajor bleeding (% difference -4.0 [95% CI: -12.8 to 0.8]). Apixaban incidence rate for all bleeding events was nearly twice the rate of other treatments (100.0 vs 58.2 per 100 person-years), driven by 12 participants with ≥4 minor bleeding events. No thromboembolic events or deaths occurred in either group. Apixaban pediatric PK steady-state exposures were consistent with adult levels.
In this pediatric multinational, randomized trial, bleeding and thromboembolism were infrequent. These results support the use of apixaban as an alternative for thromboprophylaxis in pediatric heart disease.
R. M. Payne, Am Heart J. 2019 Nov;217:52-63.