# Geïnhaleerde flecaïnide voor cardioversie van recent-onset AF: Lancet

*geplaatst 2025-03-28 · Atriumfibrilleren · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · doi 10.1093/europace/euaf064 · https://hartvaat.nl/2025/03/28/geinhaleerde-flecainide-voor-cardioversie-van-recent-onset-af-lancet/*

Lancet-trial toonde dat geïnhaleerde flecaïnide snel en effectief cardioverteert bij recent-onset symptomatisch AF. De inhalatievorm biedt een patiënt-gecontroleerde, prehospitale behandeloptie.

## English: Flecainide acetate inhalation solution for cardioversion of recent-onset, symptomatic atrial fibrillation: results of the phase 3 RESTORE-1 trial.

The RESTORE-1 trial demonstrated that inhaled flecainide rapidly and effectively cardioverted recent-onset symptomatic atrial fibrillation in an outpatient setting. The needle-free, self-administered formulation offers a patient-controlled 'pill-in-the-pocket' alternative with faster onset than oral antiarrhythmic drugs.

## Abstract (original, from the publication)

AIMS: Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia. New treatments are needed to cardiovert recent-onset paroxysmal AF quickly and safely. RESTORE-1 was a multicentre, randomized, double-blind, placebo-controlled trial of a 120 mg orally inhaled solution of flecainide acetate (FlecIH-103) for cardioversion of symptomatic, recent-onset (≤48 h) paroxysmal AF. The study aim was to evaluate the efficacy and safety of FlecIH-103 administered via oral inhalation. METHODS AND RESULTS: Patients experiencing a recent-onset paroxysmal AF episode were randomized to receive a single dose of FlecIH-103 or placebo delivered over two 3.5 min inhalation periods, while patients were monitored using 12-lead electrocardiograms and Holter. The trial was stopped prematurely after treating 55 patients, due to lower-than-expected conversion rates and plasma levels. Mean age was 59.6 years, 31.5% of patients were female, and 59.2% were having their first AF episode. Conversion rate was 30.8% (95% confidence interval: 14.7-43.8) for the active group (n = 39) and 0.0% for the placebo group (n = 12) (P = 0.04). Median time to conversion was 12.8 min (IQR: 17.2). In the active group, the mean flecainide plasma level was 198 ng/mL (SD: 156), which is ∼50% lower than in the previous studies. The most common adverse events (AEs) were dysgeusia, dyspnoea, and cough. All AEs were short-lasting and of mild or moderate intensity. CONCLUSION: Despite early termination of the trial, FlecIH-103 was significantly more effective than placebo in cardioverting AF. Safety data did not show any serious AEs. Further studies of FlecIH-103 are needed to optimize the combination of drug formulation and inhalation delivery platform. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov, unique identifier: NCT05039359.

Auteurs: Michiel Rienstra, Anderson C Woite-Silva, Aaf Kuijper, Sabine Eijsbouts, Karin Kraaier, Tomas Janota, Clara Van Ofwegen, Ype Tuininga, Erik Badings, Jose Luis Merino, Jeremy N Ruskin, A John Camm, Peter R Kowey, Christopher Dufton, Jean Maupas, Dawn Parsell, Luiz Belardinelli

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Bron: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, https://doi.org/10.1093/europace/euaf064. Bijgewerkt 2026-07-03T13:30:33Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.