An international, investigator-initiated, parallel-group, open, blinded-outcome-assessment trial concluded that early rhythm-control therapy was associated with a lower risk of cardiovascular (CV) outcomes than usual care among patients with early atrial fibrillation (AF) and CV conditions. A total of 2789 patients who had early AF (diagnosed ≤1 year before enrollment, median time since diagnosis, 36 days) underwent randomization across 135 sites in 11 European countries between July 28, 2011, and December 30, 2016. 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 (a composite of death from CV causes, stroke, or hospitalization with worsening of heart failure or acute coronary syndrome) 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). The mean number of nights spent in the hospital and 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 results suggest that the early initiation of rhythm-control therapy including all major antiarrhythmic drugs and AF ablation probably contributed to the clinical superiority of this strategy. Source: https://www.nejm.org/
