Evidence map›Paper›PMID 37226174›Full record

ArticleTrials2023

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 and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04223739 (Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.1field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04223739 phase4unknown statusnot on this map

Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery : a Randomized Multicenter Clinical Trial

TypeinterventionalSponsorUniversity Hospital, CaenRan2019 to 2022Enrolled380ConditionsAtrial Fibrillation, Cardiac SurgeryArmsLandiolol, Amiodarone
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 10 institutions in 1 country.

Edouard CaspersenDepartment of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France.
Pierre-Grégoire GuinotDepartment of Anaesthesiology and Intensive Care, Dijon University Hospital, Dijon, France.
Bertrand RozecService d'Anesthésie-Réanimation, Hôpital Laennec, CHU Nantes, Nantes, France.
Jean-Ferréol OilleauDepartment of Anesthesiology and Surgical Intensive Care Unit, Brest University Hospital, 29200, Brest, France.
Jean-Luc FellahiService d'Anesthésie-Réanimation, Hôpital Universitaire Louis Pradel, Hospices Civils de Lyon, Lyon, France.
Philippe GaudardDepartment of Anesthesiology and Critical Care Medicine Arnaud de Villeneuve, CHU Montpellier, University of Montpellier, Montpellier, France.
Emmanuel LorneDepartment of Anaesthesia and Critical Care Medicine, Clinique du Millénaire, Cedex 2, 34960, Montpellier, France.
Yazine MahjoubAnesthesia and Critical Care Department, Amiens Hospital University, Amiens, France.
Emmanuel BesnierDepartment of Anesthesiology and Critical Care, Rouen University Hospital, Rouen, France.
Mouhamed Djahoum MoussaUniv. Lille, Inserm, CHU Lille, Institut Pasteur de Lille, U1011- EGID, F-59000, Lille, France.
Nicolas MongardonUniversité Paris-Est Creteil Val de Marne, 27010, Creteil, France.
Jean-Luc HanouzDepartment of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France.
Anaïs R BriantDepartment of Biostatistics, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France.
Laure Peyro Saint PaulDepartment of Clinical Research and Innovation, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France.
Clémence TomadessoDepartment of Clinical Research and Innovation, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France.
Jean-Jacques ParientiDepartment of Biostatistics, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France.
Richard DescampsDepartment of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France.
Alina DenisenkoDepartment of Anaesthesiology-Resuscitation and Perioperative Medicine, Normandy University, UNICAEN, Caen University Hospital, Normandy, Caen, France.
Marc-Olivier FischerInstitut Aquitain du Coeur, Clinique Saint Augustin, Elsan, 114 Avenue d'Arès, 33074, Bordeaux Cedex, France. marcolivierfischer@yahoo.fr.
ARCOTHOVA Group
Université de Caen Normandie · FRInserm · FRCentre Hospitalier Régional Universitaire de Brest · FRCentre Hospitalier Universitaire Amiens-Picardie · FRClinique Charcot · FRClinique du Millénaire · FRHospices Civils de Lyon · FRUniversité de Montpellier · FRUniversité de Rouen Normandie · FRUniversité Paris-Est Créteil · FR

Funding

Direction Générale de l'offre de Soins PHRCI-19-013
6 · The paper itself

Abstract

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). 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 registrationClinicalTrials.gov NCT04223739. Registered on January 10, 2020.

Indexed as

AmiodaroneAtrial FibrillationCardiac Surgical ProceduresHumansMorpholinesMulticenter Studies as TopicRandomized Controlled Trials as TopicRetrospective StudiesSingle-Blind MethodUreaAmiodaronelandiololMorpholinesUreaAmiodaroneAnti-arrhythmic drugsAnti-coagulationAtrial fibrillationBeta-blockersCardiac surgery

Identifiers

PMID37226174
PMCPMC10210392
OpenAlexW4377965947

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.