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阿哌沙班用于 Fontan 手术后早期血栓预防的真实世界应用及结果

Real-World Use and Outcomes of Apixaban for Early Post-Surgical Fontan Thromboprophylaxis.

作者信息

Adkins Kira, Williams Ryan J, Esteso Paul, Kobayashi Ryan, Gauvreau Kimberlee, VanderPluym Christina, Hellinger Amy

机构信息

Pharmacy Department, Boston Children's Hospital, Boston, MA, USA.

Department of Pediatrics, Heart Center, Boston Children's Hospital, Boston, MA, USA.

出版信息

Pediatr Cardiol. 2024 Sep 12. doi: 10.1007/s00246-024-03641-3.

DOI:10.1007/s00246-024-03641-3
PMID:39266772
Abstract

Patients with Fontan physiology are at heightened risk of thrombosis related to passive venous return leading to increased stasis, as well as acquired thrombophilia from congestive hepatopathy. Variability exists for post-Fontan thromboprophylaxis, with no consensus on best practices. Direct oral anticoagulants offer advantages over conventional anticoagulants including fewer drug-drug interactions, no dietary restrictions, and less frequent monitoring. Herein, we report our single center experience utilizing apixaban thromboprophylaxis in children post-Fontan procedure. Single center, retrospective, cohort study evaluating apixaban thromboprophylaxis dosing strategies, efficacy, and safety in children admitted post-Fontan procedure at Boston Children's Hospital. Between September 2019 and December 2023, 62 children, median age 3.2 years (2.1-10.5 years), weight 13.9 kg (9.5-56.3 kg) received apixaban at a median of 93 days post-Fontan (7-1421 days). Over a total of 93 days of apixaban exposure, there was 1 treatment-related thrombosis event (0.07 per 1000 person-days on apixaban) and 3 combined treatment-related clinically relevant non-major (CRNM) and major bleeding events (0.22 per 1000 person-days on apixaban). Apixaban for post-Fontan thromboprophylaxis was feasible with low rates of bleeding and thrombosis.

摘要

接受Fontan手术的患者因被动静脉回流导致血流淤滞增加,以及因充血性肝病导致获得性血栓形成倾向,血栓形成风险升高。Fontan手术后的血栓预防措施存在差异,对于最佳实践尚无共识。直接口服抗凝剂相对于传统抗凝剂具有优势,包括更少的药物相互作用、无饮食限制以及监测频率更低。在此,我们报告我们在波士顿儿童医院对接受Fontan手术的儿童使用阿哌沙班进行血栓预防的单中心经验。这是一项单中心、回顾性队列研究,评估阿哌沙班在波士顿儿童医院接受Fontan手术后入院儿童中的预防给药策略、疗效和安全性。在2019年9月至2023年12月期间,62名儿童,中位年龄3.2岁(2.1 - 10.5岁),体重13.9千克(9.5 - 56.3千克)在Fontan手术后中位93天(7 - 1421天)接受了阿哌沙班治疗。在总共93天的阿哌沙班暴露期间,有1例与治疗相关的血栓形成事件(阿哌沙班治疗期间每1000人日0.07例)和3例与治疗相关的合并临床相关非大出血(CRNM)和大出血事件(阿哌沙班治疗期间每1000人日0.22例)。阿哌沙班用于Fontan手术后的血栓预防是可行的,出血和血栓形成发生率较低。

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本文引用的文献

1
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J Thromb Haemost. 2023 Jun;21(6):1601-1609. doi: 10.1016/j.jtha.2023.03.005. Epub 2023 Mar 14.
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Influence of Bovine Arch Anatomy on Surgical Outcomes of Coarctation of the Aorta.牛主动脉弓解剖结构对主动脉缩窄手术结果的影响。
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Increased Risk for Thromboembolism After Fontan Surgery: Considerations for Thromboprophylaxis.
Fontan手术后血栓栓塞风险增加:血栓预防的考量
Front Pediatr. 2022 Mar 28;10:803408. doi: 10.3389/fped.2022.803408. eCollection 2022.
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Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study.法洛四联症根治术后患儿的血栓预防:来自 UNIVERSE 研究的见解。
J Am Heart Assoc. 2021 Nov 16;10(22):e021765. doi: 10.1161/JAHA.120.021765. Epub 2021 Sep 24.
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A multi-national trial of a direct oral anticoagulant in children with cardiac disease: Design and rationale of the Safety of ApiXaban On Pediatric Heart disease On the preventioN of Embolism (SAXOPHONE) study.多国儿童心脏病患者直接口服抗凝剂试验:ApiXaban 在儿科心脏病预防栓塞安全性研究(SAXOPHONE)的设计和原理。
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Apixaban: A Clinical Pharmacokinetic and Pharmacodynamic Review.阿哌沙班:临床药代动力学和药效学评价。
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