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

被引：8

作者：

Ruskin, Jeremy N. ^{[1
]}

Camm, John ^{[2
]}

Dufton, Christopher ^{[3
]}

Woite-Silva, Anderson C. ^{[3
]}

Tuininga, Ype ^{[4
]}

Badings, Erik ^{[4
]}

De Jong, Jonas S. S. G. ^{[5
]}

Oosterhof, Thomas ^{[6
]}

Aksoy, Ismail ^{[7
]}

Kuijper, Aaf F. M. ^{[8
]}

Van Gelder, Isabelle C. ^{[9
]}

van Dijk, Vincent ^{[10
]}

Nuyens, Dieter ^{[11
]}

Schellings, Dirk ^{[12
]}

Lee, Mark Young ^{[13
]}

Kowey, Peter R. ^{[14
]}

Crijns, Harry J. G. M. ^{[15
]}

Maupas, Jean ^{[3
]}

Belardinelli, Luiz ^{[3
]}

机构：

[1] Massachusetts Gen Hosp, Boston, MA 02114 USA

[2] St Georges Univ, London, England

[3] InCarda Therapeut, Newark, CA USA

[4] Deventer Hosp, Deventer, Netherlands

[5] Onze Lieve Vrouwe Gasthuis OLVG, Amsterdam, Netherlands

[6] Ziekenhuis Gelderse Vallei, Ede, Netherlands

[7] Admiraal de Ruyter Ziekenhuis, Goes, Netherlands

[8] Spaarne Gasthuis, Haarlem, Netherlands

[9] Univ Groningen, Univ Med Ctr Groningen, Groningen, Netherlands

[10] St Antonius Hosp, Nieuwegein, Netherlands

[11] Hartctr Ziekenhuis Oost Limburg, Genk, Limburg, Belgium

[12] Slingeland Ziekenhuis, Doetinchem, Netherlands

[13] Long Beach Med Ctr, Long Beach, CA USA

[14] Lankenau Heart Inst, Wynnewood, PA USA

[15] Maastricht Univ Med Ctr MUMC, Maastricht, Netherlands

来源：

JACC-CLINICAL ELECTROPHYSIOLOGY | 2024年 / 10卷 / 06期

关键词：

atrial fi brillation; cardioversion; fl ecainide; inhalation; EMERGENCY-DEPARTMENT; INTRAVENOUS FLECAINIDE; ANTIARRHYTHMIC-DRUGS; CARDIOVERSION; MANAGEMENT; DURATION; ACETATE;

D O I：

10.1016/j.jacep.2024.02.021

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 ef ficacy 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/m 2 , 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-bene fit 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) (J Am Coll Cardiol EP 2024;10:1021 -1033) (c) 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/).

引用

页码：1021 / 1033

页数：13

共 30 条

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