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Safety and efficacy of long-term sodium channel blocker therapy for early rhythm control: the EAST-AFNET 4 trial.
Rillig, Andreas; Eckardt, Lars; Borof, Katrin; Camm, A John; Crijns, Harry J G M; Goette, Andreas; Breithardt, Günter; Lemoine, Marc D; Metzner, Andreas; Rottner, Laura; Schotten, Ulrich; Vettorazzi, Eik; Wegscheider, Karl; Zapf, Antonia; Heidbuchel, Hein; Willems, Stephan; Fabritz, Larissa; Schnabel, Renate B; Magnussen, Christina; Kirchhof, Paulus.
Afiliación
  • Rillig A; Department of Cardiology, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
  • Eckardt L; German Center for Cardiovascular Research, Partner Site Hamburg/Luebeck/Kiel, Germany.
  • Borof K; Atrial Fibrillation Network (AFNET), Mendelstraße 11, 48149 Münster, Germany.
  • Camm AJ; Department of Cardiology II-Electrophysiology, University Hospital Münster, Münster, Germany.
  • Crijns HJGM; Department of Cardiology, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
  • Goette A; Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, London, UK.
  • Breithardt G; Department of Cardiology, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht, Maastricht, The Netherlands.
  • Lemoine MD; Atrial Fibrillation Network (AFNET), Mendelstraße 11, 48149 Münster, Germany.
  • Metzner A; St. Vincenz Hospital, Paderborn, Paderborn, Germany.
  • Rottner L; Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Magdeburg, Germany.
  • Schotten U; Atrial Fibrillation Network (AFNET), Mendelstraße 11, 48149 Münster, Germany.
  • Vettorazzi E; Department of Cardiology II-Electrophysiology, University Hospital Münster, Münster, Germany.
  • Wegscheider K; Department of Cardiology, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
  • Zapf A; German Center for Cardiovascular Research, Partner Site Hamburg/Luebeck/Kiel, Germany.
  • Heidbuchel H; Department of Cardiology, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
  • Willems S; German Center for Cardiovascular Research, Partner Site Hamburg/Luebeck/Kiel, Germany.
  • Fabritz L; Department of Cardiology, University Heart and Vascular Center, University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
  • Schnabel RB; German Center for Cardiovascular Research, Partner Site Hamburg/Luebeck/Kiel, Germany.
  • Magnussen C; Department of Physiology, Maastricht University, Maastricht, The Netherlands.
  • Kirchhof P; Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Europace ; 26(6)2024 Jun 03.
Article en En | MEDLINE | ID: mdl-38702961
ABSTRACT

AIMS:

Clinical concerns exist about the potential proarrhythmic effects of the sodium channel blockers (SCBs) flecainide and propafenone in patients with cardiovascular disease. Sodium channel blockers were used to deliver early rhythm control (ERC) therapy in EAST-AFNET 4. METHODS AND

RESULTS:

We analysed the primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) and primary efficacy outcome (cardiovascular death, stroke, and hospitalization for worsening of heart failure (HF) or acute coronary syndrome) during SCB intake for patients with ERC (n = 1395) in EAST-AFNET 4. The protocol discouraged flecainide and propafenone in patients with reduced left ventricular ejection fraction and suggested stopping therapy upon QRS prolongation >25% on therapy. Flecainide or propafenone was given to 689 patients [age 69 (8) years; CHA2DS2-VASc 3.2 (1); 177 with HF; 41 with prior myocardial infarction, coronary artery bypass graft, or percutaneous coronary intervention; 26 with left ventricular hypertrophy >15 mm; median therapy duration 1153 [237, 1828] days]. The primary efficacy outcome occurred less often in patients treated with SCB [3/100 (99/3316) patient-years] than in patients who never received SCB [SCBnever 4.9/100 (150/3083) patient-years, P < 0.001]. There were numerically fewer primary safety outcomes in patients receiving SCB [2.9/100 (96/3359) patient-years] than in SCBnever patients [4.2/100 (135/3220) patient-years, adjusted P = 0.015]. Sinus rhythm at 2 years was similar between groups [SCB 537/610 (88); SCBnever 472/579 (82)].

CONCLUSION:

Long-term therapy with flecainide or propafenone appeared to be safe in the EAST-AFNET 4 trial to deliver effective ERC therapy, including in selected patients with stable cardiovascular disease such as coronary artery disease and stable HF. Clinical Trial Registration ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, www.easttrial.org.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Flecainida / Bloqueadores de los Canales de Sodio / Antiarrítmicos Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Europace Asunto de la revista: CARDIOLOGIA / FISIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Flecainida / Bloqueadores de los Canales de Sodio / Antiarrítmicos Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Europace Asunto de la revista: CARDIOLOGIA / FISIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido