From the Guidelines
Bivalirudin is not recommended for use in infants due to lack of safety data and no established association with preventing necrotizing enterocolitis (NEC). The use of bivalirudin in pediatric patients, especially neonates, is limited and not well-studied, as evident from the American Heart Association's scientific statement on prevention and treatment of thrombosis in pediatric and congenital heart disease 1.
Key Considerations
- Bivalirudin is an anticoagulant primarily used in adults for conditions like acute coronary syndrome or during percutaneous coronary interventions.
- There is very limited data regarding the use of bivalirudin in neonates, and no evidence supports its use as a preventive or therapeutic agent for NEC.
- Established strategies for NEC prevention include preferential use of human milk, standardized feeding protocols, probiotics in certain settings, and avoiding rapid advancement of feedings.
- For infants requiring anticoagulation for other reasons, more established options with pediatric dosing data such as heparin or low molecular weight heparin would typically be considered before bivalirudin, as suggested by studies on thromboprophylaxis in pediatric patients 1.
- Any anticoagulant use in infants should be carefully monitored due to their developing hemostatic systems and increased bleeding risk, highlighting the need for caution and consultation with pediatric specialists 1.
Clinical Implications
- Clinicians should consult with pediatric hematology specialists when anticoagulation is needed in this vulnerable population.
- The lack of safety data and established guidelines for bivalirudin use in infants necessitates a cautious approach, prioritizing the use of more established anticoagulants with known safety profiles in pediatric patients.
- The most recent guidelines, such as the 2021 ACC/AHA/SCAI guideline for coronary artery revascularization, provide dosing recommendations for anticoagulants like bivalirudin in adult populations but do not address its use in neonates or infants 1.
From the Research
Risk of Necrotizing Enterocolitis (NEC) in Infants Associated with Bivalrudin
- There are no research papers to assist in answering this question, as none of the provided studies 2, 3, 4, 5, 6 directly investigate the risk of necrotizing enterocolitis (NEC) in infants associated with Bivalrudin (Angiomax, generic name: Bivalirudin).
- The studies provided focus on the use of bivalirudin as an anticoagulant in pediatric patients, including its effectiveness and safety in various clinical settings, such as cardiopulmonary bypass, extracorporeal life support, and extracorporeal membrane oxygenation (ECMO) 2, 3, 4, 5, 6.
- However, none of these studies mention NEC as a potential risk or complication associated with bivalirudin use in infants.
Bivalirudin Use in Pediatric Patients
- Bivalirudin has been used as an alternative to heparin for anticoagulation in infants and children, particularly in cases of heparin-induced thrombocytopenia or heparin resistance 2, 3, 4, 5, 6.
- The studies suggest that bivalirudin is effective and safe in pediatric patients, with a lower risk of bleeding and thromboembolic complications compared to heparin 2, 3, 4, 5, 6.