Systematic, early rhythm control strategy for atrial fibrillation in patients with or without symptoms: the EAST-AFNET 4 trial

Figure 1. Consort flow chart of the patients included in this analysis showing screening, randomization, treatment, and follow-up. Of all patients included into the EAST-AFNET 4 trial, 21 of the 2810 patients did not meet the inclusion criteria of early atrial fibrillation (diagnosed ≤1 year before enrolment) and cardiovascular conditions. After exclusion of 156 patients with missing baseline symptom status, 2633 patients were included into the analysis with randomization to early rhythm control (n = 1305) or usual care (n = 1328). Most of the patients assigned to early rhythm-control were initially treated with antiarrhythmic drugs, regardless of symptom status. After 2 years of follow-up, 242 of the 395 asymptomatic patients (59.3%) and 601 of the 910 symptomatic patients (64.8%) who had been randomly assigned to early rhythm control therapy were still receiving active rhythm-control therapy [atrial fibrillation ablation in 75/395 (19.0%) asymptomatic patients and in 176/910 (19.3%) symptomatic patients; P = 0.672] randomized to early rhythm control. This corresponds to ca 25% of patients randomized to early rhythm control and still in follow-up at 24 months.

Figure 2. Aalen–Johansen cumulative-incidence curves for the first primary outcome: (A) for patients with asymptomatic atrial fibrillation at baseline and (B) for patients with symptomatic atrial fibrillation at baseline. 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 effect of early rhythm control on this outcome was almost identical in symptomatic and asymptomatic patients.

Figure 3. Change in atrial fibrillation symptoms between discharge from baseline and 24 months follow-up. There were no differences in symptom status at 24 months between randomized groups, irrespective of the presence of baseline symptoms (P = 0.1161). Symptoms improved without inter-group difference, illustrating the good adherence to protocol in patients randomized to usual care, which included symptom-directed rhythm control therapy to improve atrial fibrillation-related symptoms.