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Published on: October 12, 2012
Real-world experience of direct oral anticoagulant use in a single pediatric center
Gianna G Valenti1, Cynthia Sabo1, Michelle Hyde1
1Department of Pediatrics, Pediatric Hematology Oncology, Children's Hospital of Michigan, Detroit, Michigan, USA.
Insights
Direct oral anticoagulants (DOACs) show comparable bleeding rates in pediatric patients, but a higher recurrence of venous thromboembolism was observed. Heavy menstrual bleeding (HMB) is a significant outcome in postmenarchal females requiring further investigation.
Area of Science:
- Pediatric Hematology
- Pharmacology
- Clinical Outcomes Research
Background:
- Pediatric venous thromboembolism (VTE) incidence has risen significantly, particularly in hospitalized children.
- Direct oral anticoagulants (DOACs) present potential therapeutic advantages over traditional anticoagulants for pediatric VTE.
- Understanding the real-world effectiveness and safety of DOACs in children is crucial.
Purpose of the Study:
- To evaluate real-world epidemiological data and outcomes of pediatric patients treated with DOACs.
- To assess bleeding events, recurrent VTE, and heavy menstrual bleeding (HMB) in children on DOAC therapy.
- To compare findings with existing literature on DOACs and other anticoagulants in pediatric populations.
Main Methods:
- Retrospective review of 65 pediatric patients treated with DOACs between January 1, 2013, and December 31, 2022.
- Analysis of patient demographics, DOAC type (apixaban, rivaroxaban, dabigatran), and clinical outcomes using SPSS statistical software.
- Descriptive statistical analysis adhering to the 2023 International Society on Thrombosis and Haemostasis (ISTH) outcome definitions.
Main Results:
- Rivaroxaban was the most prescribed DOAC (61.5%), followed by apixaban (37%).
- Low rates of bleeding were observed: 2% major, 9% clinically relevant non-major, and 1.5% minor.
- Heavy menstrual bleeding (HMB) affected 5% of all patients and 19% of postmenarchal females. Recurrent VTE occurred in 9.2% of patients, with most on rivaroxaban.
Conclusions:
- DOAC therapy in pediatric patients demonstrated bleeding rates comparable to previous trials and other anticoagulants.
- Heavy menstrual bleeding (HMB) is a notable outcome in postmenarchal females and warrants continued research.
- The observed higher rate of recurrent VTE (9.2%) may be linked to ongoing risk factors and extended follow-up, necessitating further multicenter studies.
Background:
Pediatric venous thromboembolism has increased by 130%-200%, specifically in hospitalized children, and direct oral anticoagulants (DOACs) offer several therapeutic advantages.
Methods:
This study aims to evaluate the real-world epidemiological and outcome data from a retrospective review of pediatric patients treated with DOACs from January 1, 2013 to December 31, 2022. In this single-center, IRB-approved study, 65 patients were identified and analyzed using SPSS statistical software, and a descriptive statistical analysis was conducted.
Results:
Of the 65 patients, 37% were on apixaban, 61.5% were on rivaroxaban, and 1.5% were on dabigatran. Per the 2023 ISTH outcome definitions, one (2%) patient had a major bleeding episode, six (9%) had clinically relevant non-major bleeding, three (5%) patients had patient-important heavy menstrual bleeding (HMB), and one (1.5%) patient had minor bleeding. Seven (19%) of 37 postmenarchal patients had evidence of HMB. Six (9.2%) patients had recurrent venous thromboembolism while on a DOAC (one was on apixaban, and five were on rivaroxaban) and were transitioned to other forms of anticoagulation.
Conclusion:
Thus, bleeding rates after DOAC therapy are comparable to previous DOAC trials, as well as other anticoagulants in pediatrics. HMB is an important outcome measure and should continue to be investigated. This study reports a higher rate of recurrent thrombosis (9.2%) compared to other trials. However, this observation may be attributed to patients who had ongoing risk factors, as well as a longer duration of study follow-up. Additional multicentered outcome studies evaluating DOAC use in children are needed to determine long-term recurrence and HMB risks.
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