AHA - 2007: Study compares strategies to save heart failure, atrial fibrillation patients

American Heart Association's Scientific Sessions 2007

Late-Breaking Clinical Trials News Release 13

Study compares strategies to save heart failure, atrial fibrillation patients

ORLANDO, Nov. 6 – Final results were presented from a study to determine whether cardiovascular mortality can most effectively be reduced by trying to maintain a normal heart rhythm or by simply controlling the heart rate in people with both heart failure (HF) and atrial fibrillation during the late-breaking clinical trials presented at the American Heart Association’s Scientific Sessions 2007.

The Atrial Fibrillation and Congestive Heart Failure (AF-CHF) trial is a prospective, randomized, multicenter clinical trial with 1,376 patients at 123 sites in Canada, the United States, Brazil, Argentina, Europe, and Israel.

Atrial fibrillation is the most common cardiac arrhythmia, with disorganized electrical activity in the atria, the upper chambers of the heart. Afflicting tens of millions of people worldwide, it is associated with increased risk of death from heart disease and is a major cause of stroke.

HF is a serious heart condition affecting over five million people in the United States. Each year, about 550,000 people are diagnosed for the first time.

In this study, patients randomized to the heart rhythm control group underwent electrical cardioversion combined with antiarrhymic drug therapy, using amiodarone as the initial drug of choice, with sotalol or dofetilide in specific cases. In the heart rate control group, patients received titrated doses of beta-blockers and digoxin or both and pacemaker therapy if needed. Both groups received optimal heart failure management and anticoagulation.

Patients were followed for an average of 37 months. Cardiovascular death (the primary endpoint of the trial) occurred in 26.7 percent of patients in the rhythm-control group compared to 25.2 percent of patients in the rate-control group (p=0.59). Total mortality (31.8 percent vs. 32.9 percent), strokes (2.6 percent vs. 3.6 percent) and worsening HF events (27.6 percent vs. 30.8 percent) were also similar between the rhythm-control versus the rate-control group.

“We found that rhythm control does not improve mortality when compared to rate control,” said Denis Roy, M.D., principal investigator and professor and chair in the department of medicine at the University of Montreal, Quebec, Canada. “The results of the trial do not suggest that a strategy of rhythm control should be advocated for patients with atrial fibrillation and congestive heart failure.”

Support for this study was provided by the Canadian Institutes of Health Research.