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.

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.

[Not Available]. / Nouvel effet indésirable fréquent des inhibiteurs de la pompe à protons chez le sujet âgé : l'hyponatrémie modérée.

Hyponatremia is a rare side effect described in the product characteristics of proton pump inhibitors (PPIs). Hyponatremia in the elderly (>65years) was assessed in patients with exposure to PPIs for at least one year compared to controls not exposed to PPIs counterparts. Included 145 patients, twenty-four patients (16.6%) had moderate hyponatremia ([120-134] mEq/L). Forty-eight patients (33.1%) were treated with PPIs. In the end, 31.3% [18.7%-46.3%] of the treated population for more than a year by PPI suffered moderate hyponatremia against only 9.3% [14.3%-16.9%] in the rest of the population, giving an odds ratio of 4.4 ([1.8-11.1], p=0.001). The relationship between hyponatremia dose was not significant (R(2)=0.05, p=0.74). By our study, we show that the risk of moderate hyponatremia is increased by chronic use of PPI in the elderly population. We also specify a notion of prevalence between 18.7% and 46.3%.