6/28/23, 9:49 PM EAST-AFNET 4 Pathway Feedback Search Clinical Topics Home Studies EAST AFNET 4 EAST AFNET 4 Disease Atrial fibrillation Trial question What is the role of early rhythm-control therapy in patients with AF? Study design Multi-center Open label RCT Population Characteristics of study participants 46.0% female N = 2789 54.0% male 2789 patients (1293 female, 1496 male) Inclusion criteria: patients who had early AF diagnosed 1 year before enrollment and cardiovascular conditions Key exclusion criteria: any disease that limits life expectancy to < 1 year, pregnancy or breastfeeding, drug abuse, prior ablation or surgical therapy of AF, previous therapy failure on amiodarone, severe mitral valve stenosis, prosthetic mitral valve Interventions N=1395 early rhythm control (treatment with antiarrhythmic drugs or AF ablation at an early time point) N=1394 usual care (following the 2010 ESC guidelines for AF treatment) Primary outcome Incidence of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome https://web.pathway.md/studies/rec05cudwNIhrzJuY 1/2 6/28/23, 9:49 PM EAST-AFNET 4 Pathway 5.0/100 py 5 3.9 3.8/100 py 2.5/100 py 1.3/100 py Significant decrease 0.0/100 py Early rhythm control Usual care Significant decrease in the incidence of death from cardiovascular causes, stroke, or hospitalization with worsening of HF or acute coronary syndrome (3.9 /100 py vs. 5 /100 py; HR 0.79, 96% CI 0.66 to 0.94) Secondary outcomes No significant difference in the incidence of mean number of nights spent in the hospital (5.8 days / y vs. 5.1 days / y; HR 1.08, 99% CI 0.92 to 1.28) No significant difference in change in European Quality of Life-5 Dimensions score at 2 years (-1 vs. -2.7; AD 1.07, 95% CI -0.68 to 2.82) Significant decrease in change in 12-Item Short-Form General Health Survey Mental score at 2 years (0.7 vs. 1.6; AD -1.2, 95% CI -2.04 to -0.37) Safety outcomes No significant difference in symptoms of LV function at 2 years and death. Significant difference in serious adverse events related to rhythm-control therapy (4.9% vs. 1.4%). Conclusion In patients who had early AF diagnosed 1 year before enrollment and cardiovascular conditions, early rhythm control was superior to usual care with respect to the incidence of death from cardiovascular causes, stroke, or hospitalization with worsening of HF or acute coronary syndrome. Reference Paulus Kirchhof, A John Camm, Andreas Goette et al. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. Open reference URL https://web.pathway.md/studies/rec05cudwNIhrzJuY 2/2