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Title: | Safety and efficacy of long-term sodium channel blocker therapy for early rhythm control: the EAST-AFNET 4 trial | Authors: | Rillig, Andreas Eckardt, Lars Borof, Katrin Camm, A. John Crijns, Harry J. G. M. Goette, Andreas Breithardt, Guenter Lemoine, Marc D. Metzner, Andreas Rottner, Laura Schotten, Ulrich Vettorazzi, Eik Wegscheider, Karl Zapf, Antonia HEIDBUCHEL, Hein Fabritz, Larissa Willems , Stephan Schnabel, Renate B. Magnussen, Christina Kirchhof, Paulus |
Issue Date: | 2024 | Publisher: | OXFORD UNIV PRESS | Source: | EP Europace, 26 (6) (Art N° euae121) | 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; CHA(2)DS(2)-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 >15mm; 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 | Notes: | Kirchhof, P (corresponding author), Univ Med Ctr Hamburg Eppendorf, Univ Heart & Vasc Ctr, Dept Cardiol, Martinistr 52, D-20246 Hamburg, Germany.; Kirchhof, P (corresponding author), German Ctr Cardiovascular Res, Partner Site Hamburg Luebeck Kiel, Berlin, Germany.; Kirchhof, P (corresponding author), Atrial Fibrillat Network AFNET, Mendelstr 11, D-48149 Munster, Germany.; Kirchhof, P (corresponding author), Univ Birmingham, Inst Cardiovasc Sci, Birmingham, W Midlands, England. p.kirchhof@uke.de |
Keywords: | Atrial fibrillation;Early rhythm control;Sodium channel blocker;Stable cardiovascular disease;Heart failure;Coronary artery disease | Document URI: | http://hdl.handle.net/1942/45779 | ISSN: | 1099-5129 | e-ISSN: | 1532-2092 | DOI: | 10.1093/europace/euae121 | ISI #: | 001440507900002 | Rights: | The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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