"Early Rhythm-Control Therapy in Patients with Atrial Fibrillation". The New England Journal of Medicine. Published on August 29, 2020. Updated on October 13, 2020.
Clinical Question
Does early rhythm-control therapy improve outcomes over usual care in patients with early atrial fibrillation (AF) and cardiovascular (CV) conditions?
Bottom Line
Early rhythm-control therapy in patients with atrial fibrillation diagnosed ≤1 year before and with cardiovascular conditions reduced the risk of adverse cardiovascular outcomes compared to usual care, without significantly affecting the number of nights spent in the hospital.
Major Points
Guidelines
Modern guidelines do not specify the timing of rhythm vs. rate control initiation in the management of AF patients.
Design
- International, investigator-initiated, parallel-group, randomized, open, blinded-outcome-assessment trial
- N=2,789 patients with recent AF (median time since diagnosis, 36 days) and CV conditions
- Interventions: Early rhythm control vs. usual care
- Setting: 135 centers across 11 European countries
- Enrollment: 2011-2016
- Follow-up: Median 5.1 years per patient
- Analysis: Intention-to-treat
- Primary outcomes: Death from CV causes, stroke, hospitalization for worsening heart failure or acute coronary syndrome. Secondary outcomes included the number of nights in the hospital per year.
Population
Inclusion Criteria:
- Adults (≥18 years) with AF diagnosed ≤12 months before enrollment
- Patients also had either age >75 years, prior transient ischemic attack or stroke, or two additional risk factors (e.g., age >65 years, female sex, CHF, etc.)
Exclusion Criteria:
- Not specified in the summary
Baseline Characteristics:
- Mean age: 70 years, 46% female, median time since AF diagnosis 36 days
Interventions
- Early rhythm control: Treatment with antiarrhythmic drugs or AF ablation; cardioversion for persistent AF initiated after randomization
- Usual care: Rate-control therapy; rhythm control for AF-related symptom management
Outcomes
- First primary outcome event occurred less frequently in early rhythm control than usual care (hazard ratio, 0.79; 96% CI, 0.66 to 0.94; P=0.005)
- The number of nights in the hospital was not significantly different (P=0.23)
Criticisms
- Open trial design, which may introduce bias despite blinded outcome assessment
- Not designed to assess specific components of rhythm-control therapy
- Results may not generalize to patients with later initiation of rhythm-control therapy
Funding
Supported by various institutions including the German Ministry of Education and Research, German Center for Cardiovascular Research, and European Heart Rhythm Association, among others.
Further Reading
Kirchhof, P., Camm, A.J., Goette, A., et al. 2020. "Early Rhythm-Control Therapy in Patients with Atrial Fibrillation." NEJM.org.