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Orally Inhaled Flecainide for Conversion of Atrial Fibrillation to Sinus Rhythm: INSTANT Phase 2 Trial.

Ruskin, JN; Camm, AJ; Dufton, C; Woite-Silva, AC; Tuininga, Y; Badings, E; De Jong, JSSG; Oosterhof, T; Aksoy, I; Kuijper, AFM; et al. Ruskin, JN; Camm, AJ; Dufton, C; Woite-Silva, AC; Tuininga, Y; Badings, E; De Jong, JSSG; Oosterhof, T; Aksoy, I; Kuijper, AFM; Van Gelder, IC; van Dijk, V; Nuyens, D; Schellings, D; Lee, MY; Kowey, PR; Crijns, HJGM; Maupas, J; Belardinelli, L; INSTANT Investigators (2024) Orally Inhaled Flecainide for Conversion of Atrial Fibrillation to Sinus Rhythm: INSTANT Phase 2 Trial. JACC Clin Electrophysiol, 10 (6). pp. 1021-1033. ISSN 2405-5018 https://doi.org/10.1016/j.jacep.2024.02.021
SGUL Authors: Camm, Alan John

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Abstract

BACKGROUND: INSTANT (INhalation of flecainide to convert recent-onset SympTomatic Atrial fibrillatioN to sinus rhyThm) was a multicenter, open-label, single-arm study of flecainide acetate oral inhalation solution (FlecIH) for acute conversion of recent-onset (≤48 hours) symptomatic atrial fibrillation (AF) to sinus rhythm. OBJECTIVES: This study investigated the efficacy and safety in 98 patients receiving a single dose of FlecIH delivered via oral inhalation. METHODS: Patients self-administered FlecIH over 8 minutes in a supervised medical setting using a breath-actuated nebulizer and were continuously monitored for 90 minutes using a 12-lead Holter. RESULTS: Mean age was 60.5 years, mean body mass index was 27.0 kg/m2, and 34.7% of the patients were women. All patients had ≥1 AF-related symptoms at baseline, and 87.8% had AF symptoms for ≤24 hours. The conversion rate was 42.6% (95% CI: 33.0%-52.6%) with a median time to conversion of 14.6 minutes. The conversion rate was 46.9% (95% CI: 36.4%-57.7%) in a subpopulation that excluded predose flecainide exposure for the current AF episode. Median time to discharge among patients who converted was 2.5 hours, and only 2 patients had experienced AF recurrence by day 5. In the conversion-no group, 44 (81.5%) patients underwent electrical cardioversion by day 5. The most common adverse events were related to oral inhalation of flecainide (eg, cough, oropharyngeal irritation/pain), which were mostly of mild intensity and limited duration. CONCLUSIONS: The risk-benefit of orally inhaled FlecIH for acute cardioversion of recent-onset AF appears favorable. FlecIH could provide a safe, effective, and convenient first-line therapeutic option. (INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm [INSTANT]; NCT03539302).

Item Type: Article
Additional Information: © 2024 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) .
Keywords: atrial fibrillation, cardioversion, flecainide, inhalation, INSTANT Investigators, 1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences
Journal or Publication Title: JACC Clin Electrophysiol
ISSN: 2405-5018
Language: eng
Dates:
DateEvent
24 June 2024Published
10 April 2024Published Online
14 February 2024Accepted
Publisher License: Creative Commons: Attribution-Noncommercial-No Derivative Works 4.0
PubMed ID: 38613545
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/116429
Publisher's version: https://doi.org/10.1016/j.jacep.2024.02.021

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