Real-world use of apixaban for the treatment and prevention of thrombosis in children with cardiac disease
Copyright © 2023 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved..
BACKGROUND: Direct oral anticoagulants use in pediatric cardiology is poorly defined.
OBJECTIVE: We present the largest experience of apixaban use in children with heart disease, using weight- and level-based dosing.
METHODS: Retrospective single-center analysis of cardiac patients ≤19 years treated with apixaban. Patients were evaluated for safety (clinically relevant non-major [CRNM] or major bleeding; thrombotic events) and effectiveness (thrombus improvement by imaging). Peak drug-specific anti-Xa chromogenic assay results ("apixaban levels") were analyzed.
RESULTS: Over 3 years (5/2018-9/2021), 219 children, median age 6.8 years (0.3-19), median weight 20.8 kg (4.8-160) received apixaban, totaling 50,916 patient days. Of them, 172 (79%) warranted thromboprophylaxis and 47 (21%) thrombosis treatment (with 10 arterial, 19 venous, 15 intracardiac, and 3 pulmonary). The median initial peak apixaban level was 165 ng/mL (23-474; n = 125) in the prophylaxis subgroup and 153 ng/mL (30-450; n = 33) in the treatment subgroup; dosage was adjusted in response to levels in 25% of the patients. There were 4 bleeding safety events (3 CRNM; 1 major, hemoptysis complicating empyema); the serious bleeding event rate was 2.9 per 100 patient-years of apixaban. Minor bleeding events (42) were noted in 18 patients, with an additional 2 having leukopenia, 1 transaminitis, and 3 rashes. An improvement in thrombosis was seen in 95% of the treated patients with available follow-up imaging (37/39 patients).
CONCLUSION: Apixaban use was feasible with a low rate of adverse events across a diverse pediatric cardiac population using commercially available tablets dosed to weight and adjusted based on peak apixaban levels.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
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| Enthalten in: |
Journal of thrombosis and haemostasis : JTH - 21(2023), 6 vom: 28. Juni, Seite 1601-1609 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
VanderPluym, Christina [VerfasserIn] |
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| Links: |
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| Themen: |
3Z9Y7UWC1J |
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| Anmerkungen: |
Date Completed 15.05.2023 Date Revised 25.05.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jtha.2023.03.005 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM354274465 |
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| 245 | 1 | 0 | |a Real-world use of apixaban for the treatment and prevention of thrombosis in children with cardiac disease |
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| 500 | |a Date Completed 15.05.2023 | ||
| 500 | |a Date Revised 25.05.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 International Society on Thrombosis and Haemostasis. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Direct oral anticoagulants use in pediatric cardiology is poorly defined | ||
| 520 | |a OBJECTIVE: We present the largest experience of apixaban use in children with heart disease, using weight- and level-based dosing | ||
| 520 | |a METHODS: Retrospective single-center analysis of cardiac patients ≤19 years treated with apixaban. Patients were evaluated for safety (clinically relevant non-major [CRNM] or major bleeding; thrombotic events) and effectiveness (thrombus improvement by imaging). Peak drug-specific anti-Xa chromogenic assay results ("apixaban levels") were analyzed | ||
| 520 | |a RESULTS: Over 3 years (5/2018-9/2021), 219 children, median age 6.8 years (0.3-19), median weight 20.8 kg (4.8-160) received apixaban, totaling 50,916 patient days. Of them, 172 (79%) warranted thromboprophylaxis and 47 (21%) thrombosis treatment (with 10 arterial, 19 venous, 15 intracardiac, and 3 pulmonary). The median initial peak apixaban level was 165 ng/mL (23-474; n = 125) in the prophylaxis subgroup and 153 ng/mL (30-450; n = 33) in the treatment subgroup; dosage was adjusted in response to levels in 25% of the patients. There were 4 bleeding safety events (3 CRNM; 1 major, hemoptysis complicating empyema); the serious bleeding event rate was 2.9 per 100 patient-years of apixaban. Minor bleeding events (42) were noted in 18 patients, with an additional 2 having leukopenia, 1 transaminitis, and 3 rashes. An improvement in thrombosis was seen in 95% of the treated patients with available follow-up imaging (37/39 patients) | ||
| 520 | |a CONCLUSION: Apixaban use was feasible with a low rate of adverse events across a diverse pediatric cardiac population using commercially available tablets dosed to weight and adjusted based on peak apixaban levels | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Hellinger, Amy |e verfasserin |4 aut | |
| 700 | 1 | |a Ventresco, Courtney |e verfasserin |4 aut | |
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| 700 | 1 | |a Gauvreau, Kimberlee |e verfasserin |4 aut | |
| 700 | 1 | |a Esch, Jesse J |e verfasserin |4 aut | |
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