Early rhythm-control therapy was associated with a lower risk of adverse cardiovascular outcomes compared with usual care in patients diagnosed early with atrial fibrillation (AFib), according to findings from the EAST-AFNET 4 trial presented at ESC Congress 2020 and simultaneously published in the New England Journal of Medicine (NEJM).

The study randomized a total of 2,789 patients from 135 sites in 11 European countries to either early rhythm control therapy or usual care. Patients in both groups were in their first year of AFib diagnosis and had at least two cardiovascular conditions. Patients in the early rhythm control group received antiarrhythmic drugs or catheter ablation, with rhythm control therapy escalated when recurrent AFib was documented clinically or by ECG, including monitoring with patient-operated ECG devices. Patients in the usual care group were initially managed with rate control. Rhythm control therapy was only used to mitigate severe AFib-related symptoms in this group. Median follow-up was 5.1 years.

Overall results found the composite of cardiovascular death, stroke, worsening heart failure, and acute coronary syndrome occurred in 249 patients on early therapy and in 316 patients receiving usual care. The clinical benefit of early rhythm control was consistent across subgroups, including asymptomatic patients and patients without heart failure, researchers said. Additionally, while all components of the primary outcome occurred less often in patients randomized to early therapy, researchers found cardiovascular death and stroke were significantly reduced compared to usual care. There was no difference in nights spent in hospital between groups.

In terms of the primary safety outcome, there was no significant difference in the composite rate of stroke, all-cause death, and serious adverse events caused by rhythm control therapy (231 events in the early therapy group vs. 223 events in the usual care group). Complications of rhythm control therapy were more common in patients on early therapy, but occurred infrequently, in line with other recent rhythm control trials, according to principle investigator Paulus Kirchhof, MD.

"Rhythm control therapy initiated soon after diagnosis of atrial fibrillation reduces cardiovascular complications without increasing time spent in hospital and without safety concerns," Kirchhof said. "These results have the potential to completely change clinical practice towards rhythm control therapy early after the diagnosis of atrial fibrillation."

In a related editorial also published in NEJM, T. Jared Bunch, MD, FACC, and Benjamin A. Steinberg, MD, MHS, FACC, write: "The results of this trial support the use of rhythm control to reduce AFib-related adverse clinical outcomes when applied early in the treatment of patients with AFib." However, they also note that the use of other cardiovascular therapies in the trial "probably contributed to the low rates of stroke, heart failure, acute coronary syndrome, and death and highlight the need to treat AFib with comprehensive management."

Clinical Topics: Arrhythmias and Clinical EP, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: ESC Congress, ESC20, Atrial Fibrillation, Secondary Prevention, Arrhythmias, Cardiac

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