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急诊科中维纳卡兰与氟卡尼转复心房颤动的有效性和安全性:VERITA研究

Effectiveness and safety of vernakalant vs flecainide for cardioversion of atrial fibrillation in the emergency department: the VERITA study.

作者信息

Dominijanni Giuseppe, Caballero-Bermejo Antonio F, Sainz-Herrero Ana, Pineda-Torcuato Álvaro, Capilla-Pueyo Rosa, Ruiz-Antorán Belén

机构信息

Emergency Department, Hospital Universitario Puerta de Hierro, Instituto de Investigación Sanitaria Puerta de Hierro Segovia de Arana, Madrid, Spain.

Escuela de Doctorado, Universidad Autónoma de Madrid, Madrid, Spain.

出版信息

Int J Emerg Med. 2025 Aug 1;18(1):141. doi: 10.1186/s12245-025-00951-y.

DOI:10.1186/s12245-025-00951-y
PMID:40751135
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12317465/
Abstract

BACKGROUND

Vernakalant is authorized in several countries, except in the U.S., where the FDA denied its commercialization due to safety concerns, generating debate about its use.

OBJECTIVE

To compare the effectiveness and safety of intravenous (iv) vernakalant and iv flecainide in the conversion of atrial fibrillation (AF) to sinus rhythm (SR) in a hospital emergency department (ED).

DESIGN, SETTINGS AND PARTICIPANTS: A retrospective observational study was conducted, including all AF episodes treated with vernakalant or iv flecainide in the ED between January 2012 and December 2022. Clinical characteristics of each episode were analyzed following routine clinical practice.

OUTCOMES MEASURE AND ANALYSIS

The primary outcome was the percentage of episodes achieving conversion to sinus rhythm during the emergency department stay. Secondary outcomes included clinical evolution, emergency department re-presentations, and outpatient cardiology consultations recorded over a 6-month period. Subgroup analyses evaluated the effectiveness of vernakalant and flecainide by age, sex, treatment timing, heart failure history, previous atrial fibrillation episodes, AF type, and CHADS-VAS score.

MAIN FINDINGS

A total of 289 patients and 414 AF episodes were included, with 151 treated with flecainide and 263 with vernakalant. The median age was 62 years, and 57.5% were male. Vernakalant converted 76.4% of episodes to SR during the ED stay, compared to 69.5% with flecainide (p = 0.124). AF recurrence at six months was lower in the vernakalant group (20.1% vs. 29.1%; p = 0.043), with fewer ED visits for recurrent AF (0.24 vs. 0.48; p = 0.001). Vernakalant was more effective in early treatment (< 12 h after symptom onset) (82.2% vs. 70.7%; p = 0.014) and in AF with rapid ventricular response (78.1% vs. 68.0%; p = 0.044). Both drugs were well tolerated, although flecainide was associated with higher rates of bradycardia, dizziness, and hypotension.

CONCLUSIONS

Vernakalant and flecainide demonstrated similar effectiveness and safety; however, vernakalant showed superior effectiveness in early treatment, faster conversion to SR, lower AF recurrence rates, and fewer ED visits within six months.

摘要

背景

维纳卡兰在多个国家已获批准,但在美国除外,美国食品药品监督管理局(FDA)因安全担忧拒绝其商业化,引发了关于其使用的争论。

目的

比较静脉注射维纳卡兰和静脉注射氟卡尼在医院急诊科(ED)将心房颤动(AF)转为窦性心律(SR)的有效性和安全性。

设计、设置和参与者:进行了一项回顾性观察研究,纳入了2012年1月至2022年12月期间在急诊科接受维纳卡兰或静脉注射氟卡尼治疗的所有房颤发作病例。按照常规临床实践分析了每个发作病例的临床特征。

结果测量和分析

主要结局是在急诊科停留期间转为窦性心律的发作病例百分比。次要结局包括临床进展、再次到急诊科就诊情况以及6个月期间记录的门诊心脏病学会诊情况。亚组分析按年龄、性别、治疗时机、心力衰竭病史、既往房颤发作情况、房颤类型和CHADS-VAS评分评估了维纳卡兰和氟卡尼的有效性。

主要发现

共纳入289例患者和414次房颤发作病例,其中151例接受氟卡尼治疗,263例接受维纳卡兰治疗。中位年龄为62岁,男性占57.5%。在急诊科停留期间,维纳卡兰使76.4%的发作病例转为SR,而氟卡尼为69.5%(p = 0.124)。维纳卡兰组6个月时房颤复发率较低(20.1%对29.1%;p = 0.043),因房颤复发到急诊科就诊的次数较少(0.24对0.48;p = 0.001)。维纳卡兰在早期治疗(症状发作后<12小时)更有效(82.2%对70.7%;p = 0.014),在伴有快速心室反应的房颤中也更有效(78.1%对68.0%;p = 0.044)。两种药物耐受性均良好,不过氟卡尼与更高的心动过缓、头晕和低血压发生率相关。

结论

维纳卡兰和氟卡尼显示出相似的有效性和安全性;然而,维纳卡兰在早期治疗中显示出更高的有效性、更快转为SR、更低的房颤复发率以及6个月内更少的急诊科就诊次数。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c41/12317465/d33bd1f0a1ec/12245_2025_951_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c41/12317465/0adef91790ec/12245_2025_951_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c41/12317465/d33bd1f0a1ec/12245_2025_951_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c41/12317465/0adef91790ec/12245_2025_951_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c41/12317465/d33bd1f0a1ec/12245_2025_951_Fig2_HTML.jpg

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Safety and Effectiveness of Antidysrhythmic Drugs for Pharmacologic Cardioversion of Recent-Onset Atrial Fibrillation: a Systematic Review and Bayesian Network Meta-analysis.抗心律失常药物用于近期发作心房颤动药物复律的安全性和有效性:一项系统评价和贝叶斯网络Meta分析
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