Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial

Trials

Study Protocol

Yazine Mahjoub¹  Emmanuel Lorne²  Pierre-Grégoire Guinot³  Alina Denisenko⁴  Edouard Caspersen⁴  Jean-Luc Hanouz⁴  Richard Descamps⁴  Philippe Gaudard⁵  Emmanuel Besnier⁶  Jean-Ferréol Oilleau⁷  Anaïs R. Briant⁸  Jean-Jacques Parienti⁸  Laure Peyro Saint Paul⁹  Clémence Tomadesso⁹  Marc-Olivier Fischer^1,10  Bertrand Rozec^1,11  Jean-Luc Fellahi^1,12  Mouhamed Djahoum Moussa^1,13  Nicolas Mongardon^1,14 

[1] Anesthesia and Critical Care Department, Amiens Hospital University, Amiens, France;Department of Anaesthesia and Critical Care Medicine, Clinique du Millénaire, Cedex 2, 34960, Montpellier, France;Department of Anaesthesiology and Intensive Care, Dijon University Hospital, Dijon, France;University of Bourgogne and Franche-Comté, LNC UMR1231, Dijon, France;INSERM, LNC UMR1231, Dijon, France;LipSTIC LabEx, FCS Bourgogne-Franche Comté, Dijon, France;Department of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France;Department of Anesthesiology and Critical Care Medicine Arnaud de Villeneuve, CHU Montpellier, University of Montpellier, Montpellier, France;Department of Anesthesiology and Critical Care, Rouen University Hospital, Rouen, France;Department of Anesthesiology and Surgical Intensive Care Unit, Brest University Hospital, 29200, Brest, France;Department of Biostatistics, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France;Department of Clinical Research and Innovation, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France;Institut Aquitain du Coeur, Clinique Saint Augustin, Elsan, 114 Avenue d’Arès, 33074, Bordeaux Cedex, France;Service d’Anesthésie-Réanimation, Hôpital Laennec, CHU Nantes, Nantes, France;Institut du Thorax, Université de Nantes, CHU Nantes, CNRS, INSERM, Nantes, France;Service d’Anesthésie-Réanimation, Hôpital Universitaire Louis Pradel, Hospices Civils de Lyon, Lyon, France;Faculté de Médecine Lyon Est, Université Claude-Bernard, Lyon 1, Lyon, France;Univ. Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1011- EGID, F-59000, Lille, France;Université Paris-Est Creteil Val de Marne, 27010, Creteil, France;

关键词: Anti-arrhythmic drugs;    Anti-coagulation;    Amiodarone;    Atrial fibrillation;    Beta-blockers;    Cardiac surgery;   

DOI  :  10.1186/s13063-023-07353-6

 received in 2022-10-03, accepted in 2023-05-05,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPostoperative atrial fibrillation (PoAF) after cardiac surgery has a high incidence of 30%, but its management is controversial. Two strategies are recommended without evidence of a superiority of one against the other: rate control with beta-blocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with fast onset and short half-life. One retrospective, single-center study compared landiolol to amiodarone for PoAF after cardiac surgery with a better hemodynamic stability and a higher rate of reduction to sinus rhythm with landiolol, justifying the need for a multicenter randomized controlled trial. Our aim is to compare landiolol to amiodarone in the setting of PoAF after cardiac surgery with the hypothesis of a higher rate of reduction to sinus rhythm with landiolol during the 48 h after the first episode of POAF.MethodsThe FAAC trial is a multicenter single-blind two parallel-arm randomized study, which planned to include 350 patients with a first episode of PoAF following cardiac surgery. The duration of the study is 2 years. The patients are randomized in two arms: a landiolol group and an amiodarone group.Randomization (Ennov Clinical®) is performed by the anesthesiologist in charge of the patient if PoAF is persistent for at least 30 min after correction of hypovolemia, dyskalemia, and absence of pericardial effusion on a transthoracic echocardiography done at bedside.Our hypothesis is an increase of the percentage of patients in sinus rhythm from 70 to 85% with landiolol in less than 48 h after onset of PoAF (alpha risk = 5%, power = 90%, bilateral test).DiscussionThe FAAC trial was approved by the Ethics Committee of EST III with approval number 19.05.08. The FAAC trial is the first randomized controlled trial comparing landiolol to amiodarone for PoAF after cardiac surgery. In case of higher rate of reduction with landiolol, this beta-blocker could be the drug of choice used in this context as to reduce the need for anticoagulant therapy and reduce the risk of complications of anticoagulant therapy for patients with a first episode of postoperative atrial fibrillation after cardiac surgery.Trial registrationClinicalTrials.gov NCT04223739. Registered on January 10, 2020.

【 授权许可】

CC BY   
© The Author(s) 2023

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