From the Guidelines
Direct oral anticoagulants (DOACs) have a limited but growing role in pediatric neurology, particularly for conditions like cerebral venous sinus thrombosis and stroke prevention in certain cardiac conditions, with rivaroxaban being the only FDA-approved DOAC for pediatric venous thromboembolism treatment, as evidenced by recent studies 1.
Current Uses of DOACs in Pediatric Neurology
The current evidence suggests that DOACs may be considered for use in pediatric neurology patients, especially in situations where traditional anticoagulants are not effective or are contraindicated. The advantages of DOACs include their predictable pharmacokinetics, fewer drug interactions, and no need for routine monitoring 1. However, significant limitations exist, including minimal pediatric-specific safety data and lack of readily available reversal agents in emergency situations 1.
Conditions for Consideration of DOACs
DOACs might be considered for conditions like:
- Cerebral venous sinus thrombosis
- Stroke prevention in certain cardiac conditions
- Thrombotic complications of neurological disorders It is essential to note that the use of DOACs in pediatric neurology patients should be individualized based on the specific neurological condition, patient age, weight, renal function, and potential drug interactions 1.
Recommendation
When considering DOACs in pediatric neurology patients, consultation with pediatric hematology is strongly recommended, and treatment decisions should be individualized based on the specific neurological condition, patient age, weight, renal function, and potential drug interactions 1. Some key points to consider when using DOACs in pediatric neurology patients include:
- Rivaroxaban is the only FDA-approved DOAC for pediatric venous thromboembolism treatment
- Other DOACs like apixaban, dabigatran, and edoxaban lack formal pediatric approval but may be used off-label in specific situations
- The appeal of DOACs includes their predictable pharmacokinetics, fewer drug interactions than warfarin, no need for routine monitoring, and oral administration
- Significant limitations exist, including minimal pediatric-specific safety data, lack of readily available reversal agents in emergency situations, and insufficient evidence for neurological indications.
From the Research
Uses of Direct Oral Anticoagulants (DOAC) in Pediatric Neurology
- The use of DOACs, such as dabigatran and rivaroxaban, has been supported by evidence in the treatment of venous thromboembolism (VTE) in pediatric patients 2, 3, 4.
- Dabigatran has been shown to be noninferior to standard of care (SOC) in terms of efficacy, with similar bleeding rates 2.
- Rivaroxaban has been found to result in a low recurrence risk and reduced thrombotic burden, without increased risk of bleeding, compared to SOC 2, 4.
- Treatment of pediatric cerebral venous thrombosis as well as central venous catheter-related VTE with rivaroxaban appeared to be both safe and efficacious and similar to that with SOC 2.
- Dabigatran also has a favorable safety profile for prevention of VTE, and rivaroxaban has a favorable safety profile for VTE prevention in children with congenital heart disease 2.
- Several studies are ongoing to evaluate the safety and efficacy of DOACs in unique patient populations, as well as VTE prevention 2, 5, 6.
Pediatric-Specific Considerations
- Pediatric-specific considerations may limit the use of DOACs in certain children and adolescents 5.
- There is a paucity of real-world evidence to guide the use of DOACs in children who would not have met clinical trial inclusion criteria 5.
- Practical considerations for the use of DOACs in children and adolescents include the need for evidence-based pediatric guidelines and additional long-term, postauthorization studies 2, 5.