Rhythm control therapy offers a clinical benefit when initiated within one year of a diagnosis of atrial fibrillation (AF) in patients with signs or symptoms of heart failure, a sub-analysis of the EAST–AFNET 4 trial has concluded.
The findings were presented during a late-breaking trial session at the 2021 Heart Rhythm Society annual meeting (HRS 2021, 28–31 July, Boston, USA and virtual) by Andreas Rillig (Universitäres Herzzentrum Hamburg, Hamburg, Germany) and simultaneously published in Circulation.
Findings of EAST–AFNET 4 were initially presented at the 2020 European Society of Cardiology congress (ESC 2020, 29 August–1 September, virtual), concluding that patients with newly diagnosed AF benefit from early rhythm control therapy.
The latest analysis assessed the effect of systematic, early rhythm control therapy using antiarrhythmic drugs or catheter ablation compared to usual care, allowing rhythm control therapy to improve symptoms, on the two primary outcomes of the trial and on selected secondary outcomes in patients with heart failure.
According to Rillig and colleagues, even on optimal therapy, many patients with heart failure and AF experience cardiovascular complications. Additional treatments are needed to reduce these events, especially in patients with heart failure and preserved left ventricular ejection fraction (HFpEF), they note.
The analysis included a total of 798 patients (300 (37.6%) female, median age 71 [64‒76] years, 785 with known left ventricular ejection fraction [LVEF]). The majority of patients (n=442) had HFpEF (LVEF ≥50%; mean LVEF 61%±6.3%), and others had heart failure with mid-range ejection fraction (n=211; LVEF40‒49%; mean LVEF 44%±2.9%) or heart failure with reduced ejection fraction (n=132; LVEF <40%; mean LVEF 31%±5.5%).
Rillig reports that over the 5.1-year median follow-up, the composite primary outcome of cardiovascular death, stroke or hospitalisation for worsening of heart failure or for acute coronary syndrome occurred less often in patients randomised to early rhythm control (94/396; 5.7 per 100 patient-years) compared with patients randomised to usual care (130/402; 7.9 per 100 patient-years; hazard ratio 0.74 [0.56‒0.97], p=0.03), not altered by heart failure status (interaction p-value=0.63).
The primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) occurred in 71/396 (17.9%) heart failure patients randomised to early rhythm control and in 87/402 (21.6%) heart failure patients randomised to usual care (hazard ratio 0.85 [0.62-1.17], p=0.33).
Commenting on the findings, study co-author Paulus Kirchhof (University Heart and Vascular Centre UKE Hamburg, Hamburg, Germany and University of Birmingham, Birmingham, UK) told Cardiac Rhythm News: “Our sub-analysis confirms that rhythm control therapy is safe in patients with AF and heart failure. Furthermore, early and systematic initiation of rhythm control therapy can reduce important outcomes for patients, especially cardiovascular death, hospitalisation for heart failure, and stroke, in these patients. Our data support the systematic and early initiation of rhythm control therapy in patients with heart failure and AF.”