TY - JOUR
T1 - Dronedarone provides effective early rhythm control
T2 - post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria
AU - Kirchhof, Paulus
AU - Camm, A John
AU - Crijns, Harry J G M
AU - Piccini, Jonathan P
AU - Torp-Pedersen, Christian
AU - McKindley, David S
AU - Wieloch, Mattias
AU - Hohnloser, Stefan H
N1 - © The Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology.
PY - 2025/3/28
Y1 - 2025/3/28
N2 - AIMS: 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.METHODS AND RESULTS: 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).CONCLUSION: These data support the use of dronedarone for early rhythm control therapy in selected patients with early AF.TRIAL REGISTRATION: ATHENA: ClinicalTrials.gov identifier NCT00174785. EAST-AFNET 4: ClinicalTrials.gov identifier NCT01288352.
AB - AIMS: 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.METHODS AND RESULTS: 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).CONCLUSION: These data support the use of dronedarone for early rhythm control therapy in selected patients with early AF.TRIAL REGISTRATION: ATHENA: ClinicalTrials.gov identifier NCT00174785. EAST-AFNET 4: ClinicalTrials.gov identifier NCT01288352.
KW - Aged
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Acute Coronary Syndrome/mortality
KW - Anti-Arrhythmia Agents/adverse effects
KW - Atrial Fibrillation/drug therapy
KW - Atrial Flutter/drug therapy
KW - Comorbidity
KW - Double-Blind Method
KW - Dronedarone/adverse effects
KW - Heart Failure/mortality
KW - Heart Rate/drug effects
KW - Hospitalization
KW - Risk Factors
KW - Stroke/mortality
KW - Time Factors
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=105003959953&partnerID=8YFLogxK
U2 - 10.1093/europace/euaf080
DO - 10.1093/europace/euaf080
M3 - Journal article
C2 - 40295782
SN - 1099-5129
VL - 27
JO - Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
JF - Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
IS - 4
M1 - euaf080
ER -