Background:
Even on optimal therapy, many patients with heart failure and atrial fibrillation experience cardiovascular complications. Additional treatments are needed to reduce these events, especially in patients with heart failure and preserved left ventricular ejection fraction (HFpEF).
Methods:
This prespecified subanalysis of the randomized EAST - AFNET 4 trial assessed the effect of systematic, early rhythm control therapy (ERC; using antiarrhythmic drugs or catheter ablation) compared to usual care (UC, 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, defined as heart failure symptoms NYHA II-III or left ventricular ejection fraction [LVEF] <50%.
Results:
This analysis included 798 patients (300 (37.6%) female, median age 71.0 [64.0, 76.0] years, 785 with known LVEF). The majority of patients (n=442) had HFpEF (LVEF≥50%; mean LVEF 61% ± 6.3%), the 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%). Over the 5.1-year median follow-up, the composite primary outcome of cardiovascular death, stroke or hospitalization for worsening of heart failure or for acute coronary syndrome occurred less often in patients randomized to ERC (94/396; 5.7 per 100 patient-years) compared with patients randomized to UC (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 randomized to ERC and in 87/402 (21.6%) heart failure patients randomized to UC (hazard ratio 0.85 [0.62-1.17], p=0.33). LV ejection fraction improved in both groups (LVEF change at two years: ERC 5.3%±11.6%, UC 4.9%±11.6%, p=0.43). ERC also improved the composite outcome of death or hospitalization for worsening of heart failure.
Conclusions:
Rhythm control therapy conveys clinical benefit when initiated within one year of diagnosing atrial fibrillation in patients with signs or symptoms of heart failure.
Clinical Trial Registration: Unique Identifiers: ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, Study web site www.easttrial.org; URLs: www.controlled-trials.com; https://clinicaltrials.gov; https://www.clinicaltrialsregister.eu
Benefits of Permanent His Bundle Pacing Combined With Atrioventricular Node Ablation in Atrial Fibrillation Patients With Heart Failure With Both Preserved and Reduced Left Ventricular Ejection Fraction
