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Orally Inhaled Flecainide for Conversion of Atrial Fibrillation to Sinus Rhythm: INSTANT Phase 2 Trial.
Ruskin, Jeremy N; Camm, A John; Dufton, Christopher; Woite-Silva, Anderson C; Tuininga, Ype; Badings, Erik; De Jong, Jonas S S G; Oosterhof, Thomas; Aksoy, Ismail; Kuijper, Aaf F M; Van Gelder, Isabelle C; van Dijk, Vincent; Nuyens, Dieter; Schellings, Dirk; Lee, Mark Young; Kowey, Peter R; Crijns, Harry J G M; Maupas, Jean; Belardinelli, Luiz.
Afiliação
  • Ruskin JN; Massachusetts General Hospital, Boston, Massachusetts, USA. Electronic address: jruskin@mgh.harvard.edu.
  • Camm AJ; St. George's University, London, United Kingdom.
  • Dufton C; InCarda Therapeutics, Newark, California, USA.
  • Woite-Silva AC; InCarda Therapeutics, Newark, California, USA.
  • Tuininga Y; Deventer Hospital, Deventer, the Netherlands.
  • Badings E; Deventer Hospital, Deventer, the Netherlands.
  • De Jong JSSG; Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands.
  • Oosterhof T; Ziekenhuis Gelderse Vallei, Ede, the Netherlands.
  • Aksoy I; Admiraal de Ruyter Ziekenhuis, Goes, the Netherlands.
  • Kuijper AFM; Spaarne Gasthuis, Haarlem, the Netherlands.
  • Van Gelder IC; University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
  • van Dijk V; St Antonius Ziekenhuis, Nieuwegein, the Netherlands.
  • Nuyens D; Hartcentrum Ziekenhuis Oost-Limburg, Genk, Belgium.
  • Schellings D; Slingeland Ziekenhuis, Doetinchem, the Netherlands.
  • Lee MY; Long Beach Medical Center, Long Beach, California, USA.
  • Kowey PR; Lankenau Heart Institute, Wynnewood, Pennsylvania, USA.
  • Crijns HJGM; Maastricht University Medical Center (MUMC), Maastricht, the Netherlands.
  • Maupas J; InCarda Therapeutics, Newark, California, USA.
  • Belardinelli L; InCarda Therapeutics, Newark, California, USA.
JACC Clin Electrophysiol ; 10(6): 1021-1033, 2024 Jun.
Article em En | MEDLINE | ID: mdl-38613545
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).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fibrilação Atrial / Flecainida / Antiarrítmicos Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Fibrilação Atrial / Flecainida / Antiarrítmicos Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article