Kirchhof Paulus, Camm A John, Crijns Harry J G M, Piccini Jonathan P, Torp-Pedersen Christian, McKindley David S, Wieloch Mattias, Hohnloser Stefan H
Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
German Center for Cardiovascular Research, Partner Site Hamburg/Kiel/Lübeck, Germany.
Europace. 2025 Mar 28;27(4). doi: 10.1093/europace/euaf080.
This post-hoc analysis of the ATHENA trial assessed whether dronedarone (400 mg twice daily) improved cardiovascular outcomes compared with placebo in patients with early atrial fibrillation/atrial flutter (AF) and cardiovascular comorbidities, based on EAST-AFNET 4 inclusion criteria and outcomes.
The co-primary outcomes were (i) a composite of cardiovascular death, stroke, or hospitalisation due to worsening of heart failure (HF) or acute coronary syndrome (ACS) and (ii) nights spent in hospital per year. Sinus rhythm (SR) at 12 months was a secondary outcome. The primary safety outcome was a composite of death, stroke, or pre-specified serious adverse events of special interest (AESIs) related to rhythm control therapy. 1810 patients with early AF were identified. Patients receiving dronedarone had fewer deaths from cardiovascular causes, strokes, or hospitalisations due to worsening of HF or ACS compared with patients receiving placebo [dronedarone (n = 924), 87 patients with ≥1 event; placebo (n = 886), 117 patients with ≥1 event; hazard ratio 0.71; 95% confidence interval 0.54-0.94; P = 0.014]. Number of nights spent in hospital did not differ between treatment groups. More patients receiving dronedarone (69.2%) were in SR at 12 months compared with placebo (60.8%). Primary safety events comprising death, stroke, or pre-specified serious AESIs related to rhythm control therapy were not different (dronedarone vs. placebo: 60 vs. 71 patients with ≥1 event).
These data support the use of dronedarone for early rhythm control therapy in selected patients with early AF.
ATHENA: ClinicalTrials.gov identifier NCT00174785. EAST-AFNET 4: ClinicalTrials.gov identifier NCT01288352.
本ATHENA试验的事后分析基于EAST-AFNET 4纳入标准和结局，评估与安慰剂相比，决奈达隆（每日两次，每次400毫克）是否能改善早期心房颤动/心房扑动（AF）合并心血管疾病患者的心血管结局。
共同主要结局为：（i）心血管死亡、中风或因心力衰竭（HF）或急性冠状动脉综合征（ACS）恶化导致的住院综合结局；（ii）每年住院天数。12个月时的窦性心律（SR）为次要结局。主要安全性结局为与节律控制治疗相关的死亡、中风或预先指定的特殊关注严重不良事件（AESIs）的综合结局。共纳入1810例早期AF患者。与接受安慰剂的患者相比，接受决奈达隆治疗的患者因心血管原因导致的死亡、中风或因HF或ACS恶化导致的住院更少[决奈达隆组（n = 924），87例发生≥1次事件；安慰剂组（n = 886），117例发生≥1次事件；风险比0.71；95%置信区间0.54 - 0.94；P = 0.014]。治疗组间每年住院天数无差异。与安慰剂组（60.8%）相比，接受决奈达隆治疗的患者在12个月时处于SR的比例更高（69.2%）。包括死亡、中风或与节律控制治疗相关的预先指定严重AESIs在内的主要安全性事件无差异（决奈达隆组与安慰剂组：≥1次事件的患者分别为60例和71例）。
这些数据支持在选定的早期AF患者中使用决奈达隆进行早期节律控制治疗。
ATHENA：ClinicalTrials.gov标识符NCT00174785。EAST-AFNET 4：ClinicalTrials.gov标识符NCT01288352。
