The results of the Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial were presented by Denis Roy, MD, Montreal Heart Institute, Montreal, Canada. The study was funded by the Canadian Institutes of Health Research and was conducted from May 2001 through June 2007 in the US, Canada, Europe, Argentina, Brazil, and Israel. The objective of the trial was to determine if the restoration and maintenance of sinus rhythm would result in a reduction of cardiovascular mortality compared with simple rate control in patients with both CHF and AF. Eligibility criteria were as follows:

• • CHF:

  • - New York Heart Association (NYHA) Class II–IV with a left ventricular ejection fraction (LVEF) ≤35%, or

  • - NYHA I with a prior hospitalization for CHF, or

  • - LVEF ≤25%.

• • AF:

  • - one episode of AF ≥ 6 hours in the last 6 months, or

  • - one episode of shorter duration AF within the last 6 months and prior D/C shock.

Patients were randomized to one of two treatment groups. The first group was treated with rhythm control using antiarrhythmic drugs (amiodarone, sotalol, or dofetilide) or non-pharmacologic methods, including cardioversion. Patients randomized to the other treatment arm underwent rate control using beta-blockers and/or digoxin, pacemaker therapy, and AV nodal ablation when necessary. Target heart rates were <80 bpm during resting ECG and <110 bpm during the 6-minute walk. Patients in both groups were given optimal treatment for their CHF and were followed for at least 2 years. The study had 80% power to detect a 25% decrease in cardiovascular (CV) mortality.

A total of 1,376 patients were randomized—682 to rhythm control and 694 to rate control. Patient baseline demographic characteristics were similar, with the majority of the patients being men (78% in rhythm and 85% in rate control). There were 217 (31.8%) deaths in the rhythm control group and 228 (32.9%) in the rate control group; 80% of the deaths were CV-related. The study did not meet its primary objective of reducing CV mortality by 25% using rhythm control (HR 1.06; p=0.59), nor were there any statistically significant differences in secondary measures of overall survival, stroke, worsening CHF, or a composite of CV death, worsening CHF, and stroke. Additionally, no prespecified subgroup of patients displayed a significantly higher or lower risk of CV death. A statistically significantly higher number of patients in the rhythm control group required hospitalization at 12 months (46% vs 39%; p=0.006).

“Rhythm control does not improve cardiovascular mortality compared with a rate-control strategy in patients with AF and CHF,” summarized Dr. Roy.