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Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED)

Pharmacologic cardioversion is a well-established alternative to electric cardioversion for hemodynamically stable patients, as it skips the risks associated with anesthesia. A recent network meta-analysis identifies the most effective antiarrhythmics for pharmacologic cardioversion with flecainide...

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Autores principales: Tsioufis, Panagiotis, Tsiachris, Dimitris, Doundoulakis, Ioannis, Kordalis, Athanasios, Antoniou, Christos-Konstantinos, Vlachakis, Panayotis K., Theofilis, Panagiotis, Manta, Eleni, Gatzoulis, Konstantinos A., Parissis, John, Tsioufis, Konstantinos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10299428/
https://www.ncbi.nlm.nih.gov/pubmed/37373655
http://dx.doi.org/10.3390/jcm12123961
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author Tsioufis, Panagiotis
Tsiachris, Dimitris
Doundoulakis, Ioannis
Kordalis, Athanasios
Antoniou, Christos-Konstantinos
Vlachakis, Panayotis K.
Theofilis, Panagiotis
Manta, Eleni
Gatzoulis, Konstantinos A.
Parissis, John
Tsioufis, Konstantinos
author_facet Tsioufis, Panagiotis
Tsiachris, Dimitris
Doundoulakis, Ioannis
Kordalis, Athanasios
Antoniou, Christos-Konstantinos
Vlachakis, Panayotis K.
Theofilis, Panagiotis
Manta, Eleni
Gatzoulis, Konstantinos A.
Parissis, John
Tsioufis, Konstantinos
author_sort Tsioufis, Panagiotis
collection PubMed
description Pharmacologic cardioversion is a well-established alternative to electric cardioversion for hemodynamically stable patients, as it skips the risks associated with anesthesia. A recent network meta-analysis identifies the most effective antiarrhythmics for pharmacologic cardioversion with flecainide exhibiting a more efficacious and safer profile towards faster cardioversion. Moreover, the meta-analysis of class Ic antiarrhythmics revealed an absence of adverse events when used for pharmacologic cardioversion of AF in the ED, including patients with structural heart disease. The primary goals of this clinical trial are to prove the superiority of flecainide over amiodarone in the successful cardioversion of paroxysmal atrial fibrillation in the Emergency Department and to prove that the safety of flecainide is non-inferior to amiodarone in patients with coronary artery disease without residual ischemia, and an ejection fraction over 35%. The secondary goals of this study are to prove the superiority of flecainide over amiodarone in the reduction in hospitalizations from the Emergency Department due to atrial fibrillation in the time taken to achieve cardioversion, and in the reduction in the need to conduct electrical cardioversion.
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spelling pubmed-102994282023-06-28 Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED) Tsioufis, Panagiotis Tsiachris, Dimitris Doundoulakis, Ioannis Kordalis, Athanasios Antoniou, Christos-Konstantinos Vlachakis, Panayotis K. Theofilis, Panagiotis Manta, Eleni Gatzoulis, Konstantinos A. Parissis, John Tsioufis, Konstantinos J Clin Med Study Protocol Pharmacologic cardioversion is a well-established alternative to electric cardioversion for hemodynamically stable patients, as it skips the risks associated with anesthesia. A recent network meta-analysis identifies the most effective antiarrhythmics for pharmacologic cardioversion with flecainide exhibiting a more efficacious and safer profile towards faster cardioversion. Moreover, the meta-analysis of class Ic antiarrhythmics revealed an absence of adverse events when used for pharmacologic cardioversion of AF in the ED, including patients with structural heart disease. The primary goals of this clinical trial are to prove the superiority of flecainide over amiodarone in the successful cardioversion of paroxysmal atrial fibrillation in the Emergency Department and to prove that the safety of flecainide is non-inferior to amiodarone in patients with coronary artery disease without residual ischemia, and an ejection fraction over 35%. The secondary goals of this study are to prove the superiority of flecainide over amiodarone in the reduction in hospitalizations from the Emergency Department due to atrial fibrillation in the time taken to achieve cardioversion, and in the reduction in the need to conduct electrical cardioversion. MDPI 2023-06-10 /pmc/articles/PMC10299428/ /pubmed/37373655 http://dx.doi.org/10.3390/jcm12123961 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Study Protocol
Tsioufis, Panagiotis
Tsiachris, Dimitris
Doundoulakis, Ioannis
Kordalis, Athanasios
Antoniou, Christos-Konstantinos
Vlachakis, Panayotis K.
Theofilis, Panagiotis
Manta, Eleni
Gatzoulis, Konstantinos A.
Parissis, John
Tsioufis, Konstantinos
Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED)
title Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED)
title_full Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED)
title_fullStr Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED)
title_full_unstemmed Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED)
title_short Rationale and Design of a Randomized Controlled Clinical Trial on the Safety and Efficacy of Flecainide versus Amiodarone in the Cardioversion of Atrial Fibrillation at the Emergency Department in Patients with Coronary Artery Disease (FLECA-ED)
title_sort rationale and design of a randomized controlled clinical trial on the safety and efficacy of flecainide versus amiodarone in the cardioversion of atrial fibrillation at the emergency department in patients with coronary artery disease (fleca-ed)
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10299428/
https://www.ncbi.nlm.nih.gov/pubmed/37373655
http://dx.doi.org/10.3390/jcm12123961
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