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
Edouard Caspersen,
Pierre-Grégoire Guinot,
Bertrand Rozec,
Jean-Ferréol Oilleau,
Jean-Luc Fellahi,
Philippe Gaudard,
Emmanuel Lorne,
Yazine Mahjoub,
Emmanuel Besnier,
Mouhamed Djahoum Moussa,
Nicolas Mongardon,
Jean-Luc Hanouz,
Anaïs R. Briant,
Laure Peyro Saint Paul,
Clémence Tomadesso,
Jean-Jacques Parienti,
Richard Descamps,
Alina Denisenko,
Marc-Olivier Fischer,
for the ARCOTHOVA Group
Affiliations
Edouard Caspersen
Department of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital
Pierre-Grégoire Guinot
Department of Anaesthesiology and Intensive Care, Dijon University Hospital
Bertrand Rozec
Service d’Anesthésie-Réanimation, Hôpital Laennec, CHU Nantes
Jean-Ferréol Oilleau
Department of Anesthesiology and Surgical Intensive Care Unit, Brest University Hospital
Jean-Luc Fellahi
Service d’Anesthésie-Réanimation, Hôpital Universitaire Louis Pradel
Philippe Gaudard
Department of Anesthesiology and Critical Care Medicine Arnaud de Villeneuve, CHU Montpellier, University of Montpellier
Emmanuel Lorne
Department of Anaesthesia and Critical Care Medicine, Clinique du Millénaire
Yazine Mahjoub
Anesthesia and Critical Care Department, Amiens Hospital University
Emmanuel Besnier
Department of Anesthesiology and Critical Care, Rouen University Hospital
Mouhamed Djahoum Moussa
Univ. Lille, Inserm, CHU Lille, Institut Pasteur de Lille
Nicolas Mongardon
Université Paris-Est Creteil Val de Marne
Jean-Luc Hanouz
Department of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital
Anaïs R. Briant
Department of Biostatistics, Normandy University, UNICAEN, Caen University Hospital
Laure Peyro Saint Paul
Department of Clinical Research and Innovation, Normandy University, UNICAEN, Caen University Hospital
Clémence Tomadesso
Department of Clinical Research and Innovation, Normandy University, UNICAEN, Caen University Hospital
Jean-Jacques Parienti
Department of Biostatistics, Normandy University, UNICAEN, Caen University Hospital
Richard Descamps
Department of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital
Alina Denisenko
Department of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital
Marc-Olivier Fischer
Institut Aquitain du Coeur, Clinique Saint Augustin
Abstract Background Postoperative 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. Methods The 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). Discussion The 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 registration ClinicalTrials.gov NCT04223739. Registered on January 10, 2020.
