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Aims <p>Concerns exist about the safety of amiodarone and dronedarone. We assessed the long-term outcome of both drugs for early rhythm control (ERC) in the EAST-AFNET 4 trial.</p> Methods and Results <p>Patients randomized for ERC and treated with amiodarone or dronedarone were compared to other ERC-therapies. Patients receiving amiodarone or dronedarone at initial therapy (n = 653/1395) were older with more comorbidities and less paroxysmal atrial fibrillation (AF, 29%) compared to patients never receiving amiodarone or dronedarone (Amiodarone/Dronedarone<sup>never</sup>, 43% paroxysmal AF). Patients treated with amiodarone had more often heart failure (HF, 42%) and persistent AF (40%) compared to patients treated with dronedarone (16% HF, 15% persistent AF) and Amiodarone/Dronedarone<sup>never</sup> (25% HF, 22% persistent AF). 115/398 amiodarone-treated patients (6.7/100 patient-years) and 51/255 dronedarone-treated patients (4.2/100 patient-years) experienced a primary efficacy outcome (cardiovascular death, stroke, HF-hospitalization or acute coronary syndrome), while 98/398 (5.3/100 patient-years) and 43/255 (3.4/100 patient-years) experienced a primary safety outcome (death, stroke or serious adverse events related to rhythm-control therapy). Serious adverse events related to drug therapy were similar for amiodarone (1.4/100 patient-years), dronedarone (1.2/100 patient-years), and other ERC (0.8/100 patient-years). Dronedarone (hazard ratio (HR) 0.5; CI 0.28–0.91), age (HR 1.05; CI 1.03–1.07), coronary artery disease (HR 1.84; CI 1.38–2.46) and stable HF (HR 1.66; CI 1.28–2.16) were associated with efficacy outcome upon multivariate Cox regression. Age (HR 1.07; CI 1.05–1.09) and left ventricular hypertrophy (HR 1.94; CI 1.13–3.32) were associated with safety outcome.</p> Conclusion <p>Early rhythm control using amiodarone or dronedarone rarely led to drug-related serious adverse events in EAST-AFNET 4.</p> <p><i>Clinical Trial Registration</i>: ISRCTN04708680, NCT01288352, EudraCT2010-021258-20.</p> Graphical abstract <p>Central illustration</p> <p></p>

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Safety and efficacy of amiodarone and dronedarone for early rhythm control in EAST-AFNET 4

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月19日

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  • Laura Rottner,
  • Marc D. Lemoine,
  • Lars Eckardt,
  • Katrin Borof,
  • A. John Camm,
  • Andreas Goette,
  • Günter Breithardt,
  • Andreas Metzner,
  • Ulrich Schotten,
  • Antonia Zapf,
  • Hein Heidbüchel,
  • Stephan Willems,
  • Harry Crijns,
  • Renate B. Schnabel,
  • Larissa Fabritz,
  • Christina Magnussen,
  • Andreas Rillig,
  • Paulus Kirchhof

摘要

Aims

Concerns exist about the safety of amiodarone and dronedarone. We assessed the long-term outcome of both drugs for early rhythm control (ERC) in the EAST-AFNET 4 trial.

Methods and Results

Patients randomized for ERC and treated with amiodarone or dronedarone were compared to other ERC-therapies. Patients receiving amiodarone or dronedarone at initial therapy (n = 653/1395) were older with more comorbidities and less paroxysmal atrial fibrillation (AF, 29%) compared to patients never receiving amiodarone or dronedarone (Amiodarone/Dronedaronenever, 43% paroxysmal AF). Patients treated with amiodarone had more often heart failure (HF, 42%) and persistent AF (40%) compared to patients treated with dronedarone (16% HF, 15% persistent AF) and Amiodarone/Dronedaronenever (25% HF, 22% persistent AF). 115/398 amiodarone-treated patients (6.7/100 patient-years) and 51/255 dronedarone-treated patients (4.2/100 patient-years) experienced a primary efficacy outcome (cardiovascular death, stroke, HF-hospitalization or acute coronary syndrome), while 98/398 (5.3/100 patient-years) and 43/255 (3.4/100 patient-years) experienced a primary safety outcome (death, stroke or serious adverse events related to rhythm-control therapy). Serious adverse events related to drug therapy were similar for amiodarone (1.4/100 patient-years), dronedarone (1.2/100 patient-years), and other ERC (0.8/100 patient-years). Dronedarone (hazard ratio (HR) 0.5; CI 0.28–0.91), age (HR 1.05; CI 1.03–1.07), coronary artery disease (HR 1.84; CI 1.38–2.46) and stable HF (HR 1.66; CI 1.28–2.16) were associated with efficacy outcome upon multivariate Cox regression. Age (HR 1.07; CI 1.05–1.09) and left ventricular hypertrophy (HR 1.94; CI 1.13–3.32) were associated with safety outcome.

Conclusion

Early rhythm control using amiodarone or dronedarone rarely led to drug-related serious adverse events in EAST-AFNET 4.

Clinical Trial Registration: ISRCTN04708680, NCT01288352, EudraCT2010-021258-20.

Graphical abstract

Central illustration