TY - JOUR
T1 - Early Rhythm-Control Therapy in Patients with Atrial Fibrillation
AU - EAST-AFNET 4 Trial Investigators
AU - Kirchhof, Paulus
AU - Camm, A. John
AU - Goette, Andreas
AU - Brandes, Axel
AU - Eckardt, Lars
AU - Elvan, Arif
AU - Fetsch, Thomas
AU - van Gelder, Isabelle C.
AU - Haase, Doreen
AU - Haegeli, Laurent M.
AU - Hamann, Frank
AU - Heidbuchel, Hein
AU - Hindricks, Gerhard
AU - Kautzner, Josef
AU - Kuck, Karl-Heinz
AU - Mont, Lluis
AU - Ng, G. Andre
AU - Rekosz, Jerzy
AU - Schoen, Norbert
AU - Schotten, Ulrich
AU - Suling, Anna
AU - Taggeselle, Jens
AU - Themistoclakis, Sakis
AU - Vettorazzi, Eik
AU - Vardas, Panos
AU - Wegscheider, Karl
AU - Willems, Stephan
AU - Crijns, Harry J. G. M.
AU - Breithardt, Gunter
PY - 2020/10/1
Y1 - 2020/10/1
N2 - BackgroundDespite improvements in the management of atrial fibrillation, patients with this condition remain at increased risk for cardiovascular complications. It is unclear whether early rhythm-control therapy can reduce this risk.MethodsIn this international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial, we randomly assigned patients who had early atrial fibrillation (diagnosedResultsIn 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization. The trial was stopped for efficacy at the third interim analysis after a median of 5.1 years of follow-up per patient. A first-primary-outcome event occurred in 249 of the patients assigned to early rhythm control (3.9 per 100 person-years) and in 316 patients assigned to usual care (5.0 per 100 person-years) (hazard ratio, 0.79; 96% confidence interval, 0.66 to 0.94; P=0.005). The mean (SD) number of nights spent in the hospital did not differ significantly between the groups (5.821.9 and 5.1 +/- 15.5 days per year, respectively; P=0.23). The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care. Symptoms and left ventricular function at 2 years did not differ significantly between the groups.Conclusions Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions. (Funded by the German Ministry of Education and Research and others; EAST-AFNET 4 ISRCTN number, ISRCTN04708680; ClinicalTrials.gov number, NCT01288352; EudraCT number, 2010-021258-20.)In this multicenter, randomized trial comparing early rhythm control with usual care in patients with early atrial fibrillation and cardiovascular conditions, early rhythm control reduced the rate of death from cardiovascular causes and cardiovascular complications and did not affect the number of nights in the hospital.
AB - BackgroundDespite improvements in the management of atrial fibrillation, patients with this condition remain at increased risk for cardiovascular complications. It is unclear whether early rhythm-control therapy can reduce this risk.MethodsIn this international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial, we randomly assigned patients who had early atrial fibrillation (diagnosedResultsIn 135 centers, 2789 patients with early atrial fibrillation (median time since diagnosis, 36 days) underwent randomization. The trial was stopped for efficacy at the third interim analysis after a median of 5.1 years of follow-up per patient. A first-primary-outcome event occurred in 249 of the patients assigned to early rhythm control (3.9 per 100 person-years) and in 316 patients assigned to usual care (5.0 per 100 person-years) (hazard ratio, 0.79; 96% confidence interval, 0.66 to 0.94; P=0.005). The mean (SD) number of nights spent in the hospital did not differ significantly between the groups (5.821.9 and 5.1 +/- 15.5 days per year, respectively; P=0.23). The percentage of patients with a primary safety outcome event did not differ significantly between the groups; serious adverse events related to rhythm-control therapy occurred in 4.9% of the patients assigned to early rhythm control and 1.4% of the patients assigned to usual care. Symptoms and left ventricular function at 2 years did not differ significantly between the groups.Conclusions Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients with early atrial fibrillation and cardiovascular conditions. (Funded by the German Ministry of Education and Research and others; EAST-AFNET 4 ISRCTN number, ISRCTN04708680; ClinicalTrials.gov number, NCT01288352; EudraCT number, 2010-021258-20.)In this multicenter, randomized trial comparing early rhythm control with usual care in patients with early atrial fibrillation and cardiovascular conditions, early rhythm control reduced the rate of death from cardiovascular causes and cardiovascular complications and did not affect the number of nights in the hospital.
KW - CATHETER ABLATION
KW - MANAGEMENT
KW - RISK
KW - STROKE
KW - DRONEDARONE
KW - GUIDELINES
KW - SAFETY
KW - DEATH
U2 - 10.1056/NEJMoa2019422
DO - 10.1056/NEJMoa2019422
M3 - Article
SN - 0028-4793
VL - 383
SP - 1305
EP - 1316
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 14
ER -