{"id":"f0421cb010d8","type":"article","url":"https://hartvaat.nl/2025/03/28/geinhaleerde-flecainide-voor-cardioversie-van-recent-onset-af-lancet/","title":"Geïnhaleerde flecaïnide voor cardioversie van recent-onset AF: Lancet","title_en":"Flecainide acetate inhalation solution for cardioversion of recent-onset, symptomatic atrial fibrillation: results of the phase 3 RESTORE-1 trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["apotheker","cardioloog"],"tags":["roken"],"journal":"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","source_url":"https://doi.org/10.1093/europace/euaf064","authors":["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"],"significance":9,"published":"2025-03-28","source_date":"2025-03-28","image":"","kennis":["https://hartvaat.nl/kennis/atriumfibrilleren/abc-pad-af/"],"congress":"","summary_en":"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.","created":"2026-07-03T10:31:32Z","updated":"2026-07-03T13:30:33Z","licence":"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.","body_markdown":"Lancet-trial toonde dat geïnhaleerde flecaïnide snel en effectief cardioverteert bij recent-onset symptomatisch AF. De inhalatievorm biedt een patiënt-gecontroleerde, prehospitale behandeloptie.","abstract_original":"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."}