Background: Despite advances in AFib management, up to 5% of patients will have a major complication each year. Current guidelines favor rate control based on prior studies that did not show mortality benefit with rhythm control. By expanding the rhythm strategy to include catheter ablation in early AFib, this trial re-examines if implementing rhythm control leads to improved clinical outcomes.
Study design: Prospective, open blinded randomized controlled trial.
Setting: 135 centers in 11 European countries.
Synopsis: Of patients with a new AFib diagnosis (less than 1 year, median 36 days), 2,789 were randomized 1:1 to rhythm control or usual care. Patients were 75 years old or older with prior CVA or 2 or fewer cardiovascular conditions. Both arms were continued on guideline-directed treatment, including rate control medications and anticoagulation. Rhythm control involved use of antiarrhythmics, catheter ablation (8% at enrollment, 20% by 5 years), or early cardioversion. Patients assigned to rhythm control had a lower risk for primary composite outcome of CV death, stroke, or hospitalization for worsening heart failure or acute coronary syndrome (HR, 0.79; 96% confidence interval, 0.66-0.94; P = .005) at 5 years, and the trial was stopped early for efficacy. Despite the 21% relative risk reduction, the absolute risk reduction was modest at 1.1 per 100 person-years. There were no significant differences in composite rate of all-cause mortality, although more adverse events occurred in the rhythm arm (4.9% vs. 1%). Overall rates of stroke and death were relatively low in both groups, underscoring the importance of continuing guideline-directed therapy. Hospital days were similar between the two groups, suggesting that rhythm control is not associated with higher cost burden. Limitations include its open-label design, loss of patients to follow-up (9% in control arm), and lack of generalizability to patients with long-standing AFib.
Bottom line: Early initiation of rhythm control therapy was associated with improved outcomes in patients with newly diagnosed AFib compared with usual care alone.
Citation: Kirchhof P et al. Early rhythm-control therapy in patients with atrial fibrillation. N Engl J Med. 2020 Aug 29;383:1305-1316. doi: 10.1056/NEJMoa2019422.
Dr. Korovaichuk is a hospitalist at Northwestern Memorial Hospital and assistant professor of medicine, Feinberg School of Medicine, both in Chicago.