Early rhythm-control therapy improves cardiovascular outcomes in AF: NEJM

Recently, a study trial, published in the New England Journal Of Medicine, has established that 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. Researchers have valid data from EAST-AFNET 4 (NCT01288352), a multinational European trial in which 2789 patients (mean age, 70) with recently diagnosed AF (median time from diagnosis, 36 days) were randomized to early rhythm control or usual care (i.e., initial aggressive rate control, with rhythm control for symptoms).

A team under Paulus Kirchhof , at the Department of Cardiology, University Heart and Vascular Center (P.K.), and Institute of Medical Biometry and Epidemiology (A.S., E.V., K.W.), University Medical Center Hamburg–Eppendorf, designed a international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial, which randomly assigned patients who had early atrial fibrillation (diagnosed ≤1 year before enrollment) and cardiovascular conditions to receive either early rhythm control or usual care.

Early rhythm control included treatment with antiarrhythmic drugs or atrial fibrillation ablation after randomization. Usual care limited rhythm control to the management of atrial fibrillation–related symptoms.

The first primary outcome was a composite of death from cardiovascular causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome; the second primary outcome was the number of nights spent in the hospital per year.

The primary safety outcome was a composite of death, stroke, or serious adverse events related to rhythm-control therapy. Secondary outcomes, including symptoms and left ventricular function, were also evaluated.

The results highlighted the following facts.

• In 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 (5.8±21.9 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.

"The trial was stopped early, at a median of 5.1 years of follow-up per patient, because the incidence of a first-primary-outcome event — cardiovascular death, stroke, or hospitalization with worsening heart failure or acute coronary syndrome — was significantly lower in the rhythm-control group than the usual-care group." wrote the team.

Primary source: England Journal Of Medicine

For full article click link; DOI: 10.1056/NEJMoa2019422