Current Real-World Status of Off-Label Under- and Over-Dose of Direct Oral Anticoagulants After Atrial Fibrillation Ablation.

IF 2.3 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Journal of Cardiovascular Electrophysiology Pub Date : 2025-01-07 DOI:10.1111/jce.16560

Tabito Kino, Akihiko Nogami, Kyoko Soejima, Kikuya Uno, Koichiro Kumagai, Takashi Kurita, Masayuki Fukuzawa, Atsushi Takita, Tomoko Ishizu, Kazutaka Aonuma

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引用次数: 0

Abstract

Background: Off-label under- and overdosing of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) is not uncommon in real-world practice.

Objective: This study aimed to identify efficacy and safety of off-label DOACs dose after AF ablation.

Methods: The RYOUMA registry was a prospective multicenter study of Japanese patients who underwent AF ablation between 2017 and 2018. DOAC prescriptions were categorized into on-label standard dose, on-label reduced dose, off-label underdose, and off-label overdose.

Results: The proportion of off-label doses among patients after AF ablation varied depending on the type of DOAC, ranging from 13.5% to 34.9%. Of 2821 patients, 366 (13.0%) were prescribed an off-label underdose and exhibited significantly higher CHADS₂, CHA₂DS₂-VASc, CHA₂DS₂-VA, HELT-E₂S₂, and HAS-BLED scores, age, concomitant use of antiplatelets, and lower weight when compared to the on-label standard dose (n = 1809). While the incidence of ischemic stroke after 1 year of off-label underdose was notably low (0.28%), the rate of major bleeding was relatively high (1.7%). Off-label overdose was prescribed to 134 patients (4.8%), who showed a significantly higher incidence of major bleeding (3.0%) compared to on-label standard dose (0.91%; p = 0.02). The off-label overdose group did not have any particular background and its thromboembolic risk was, conversely, low. The most likely cause of off-label overdose was clinicians potentially overlooking dose criteria, including advanced age, low body weight, and low creatinine clearance.

Conclusions: In patients after AF ablation, off-label DOAC overdose was infrequent, but significantly associated with higher incidence of major bleeding during the remote period after AF ablation.

Trial registration: The study was registered as UMIN000026092 (University Hospital Medical Information Network-Clinical Trial Registry).

查看原文本刊更多论文

心房颤动消融后直接口服抗凝药物超说明书剂量不足和过量的现状。

背景：心房颤动（AF）患者直接口服抗凝剂（DOACs）的超说明书用药不足和过量在现实生活中并不罕见。目的：本研究旨在确定房颤消融后超说明书DOACs剂量的有效性和安全性。RYOUMA注册是一项前瞻性多中心研究，研究对象是2017年至2018年间接受房颤消融的日本患者。DOAC处方分为标签上的标准剂量、标签上的减少剂量、标签外的不足剂量和标签外的过量剂量。结果：房颤消融后患者超说明书剂量的比例因DOAC类型的不同而不同，范围为13.5% ~ 34.9%。在2821例患者中，366例（13.0%）患者的处方剂量低于标签，与标签标准剂量相比，CHADS2、CHA2DS2-VASc、CHA2DS2-VA、HELT-E2S2和ha - bled评分、年龄、同时使用抗血小板药物和体重较低（n = 1809）。超说明书剂量不足1年后缺血性脑卒中发生率明显较低（0.28%），大出血发生率相对较高（1.7%）。134例（4.8%）患者服用超说明书用药过量，其大出血发生率（3.0%）明显高于超说明书标准剂量(0.91%；p = 0.02)。标签外用药过量组没有任何特殊的背景，相反，其血栓栓塞风险较低。超说明书用药过量最可能的原因是临床医生可能忽略了剂量标准，包括高龄、低体重和低肌酐清除率。结论：在房颤消融后患者中，超说明书DOAC过量的情况并不多见，但与房颤消融后较长时期大出血的发生率显著相关。试验注册：研究注册号为UMIN000026092（大学医院医学信息网-临床试验注册）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Cardiovascular Electrophysiology 医学-心血管系统

CiteScore

5.20

自引率

14.80%

发文量

433

审稿时长

3-6 weeks

期刊介绍： Journal of Cardiovascular Electrophysiology (JCE) keeps its readership well informed of the latest developments in the study and management of arrhythmic disorders. Edited by Bradley P. Knight, M.D., and a distinguished international editorial board, JCE is the leading journal devoted to the study of the electrophysiology of the heart.