NEW ORLEANS — Maintenance of sinus rhythm in patients with persistent atrial fibrillation leads to significantly better quality of life and exercise performance scores—contrary to the findings of several prior highly publicized clinical trials, Steven N. Singh, M.D., said at the annual meeting of the Heart Rhythm Society.
“These observations may have a major impact on the controversy regarding the rhythm or rate control approach to management of patients with atrial fibrillation,” added Dr. Singh of the Veterans Affairs Medical Center in Washington.
He presented a secondary quality of life analysis of the Sotalol Amiodarone Atrial Fibrillation Efficacy Trial (SAFE-T), a double-blind, randomized multicenter VA-sponsored study in which 665 patients with persistent atrial fibrillation were placed on amiodarone, sotalol, or placebo and followed for 1 year.
He noted that the primary SAFE-T results, which were recently published, show that while amiodarone and sotalol were equally effective in converting atrial fibrillation to sinus rhythm, amiodarone was clearly superior at maintaining sinus rhythm (N. Engl. J. Med. 2005;352:1861–72).
Dr. Singh, SAFE-T co-principal investigator, presented a prespecified secondary quality of life outcomes analysis.
Three previous major, randomized controlled trials—the Atrial Fibrillation in Followup Investigation of Rhythm Management (AFFIRM), Pharmacologic Intervention in Atrial Fibrillation (PIAF), and Rate Control Versus Electrical Cardioversion (RACE)—had concluded that there is little difference in quality of life between the rate and rhythm control strategies.
But the SAFE-T investigators were skeptical of this result.
All three prior trials had used an intention-to-treat statistical analysis. The SAFE-T investigators believed it made more sense to analyze outcomes on the basis of whether patients were actually in sinus rhythm as determined using telemetry readings obtained weekly throughout the follow-up period.
In SAFE-T, quality of life and exercise performance were measured at baseline, 8 weeks, and 1 year. At both 8 weeks and 1 year, patients in sinus rhythm showed clear advantages over those in atrial fibrillation in terms of these outcomes.
At 1 year, for example, the sinus rhythm group fared significantly better than patients in atrial fibrillation on four of the eight subscales of the Short Form-36 general quality of life scale. They also scored better in measures of specific symptom severity, exercise capacity, and heart rate. (See box.)
Patients whose atrial fibrillation had been asymptomatic at baseline also derived quality of life benefit from being maintained in sinus rhythm, although the magnitude of improvement was less than in symptomatic patients.
“In all fairness to the AFFIRM, RACE, and PIAF trials, which showed that there is no benefit for maintenance of sinus rhythm with respect to quality of life, I strongly believe that their analysis, which was done by intention to treat, is perhaps not the right way to do it, because 40% of the patients in the sinus-rhythm arm were actually in atrial fibrillation. … I think intent to treat is good for the statisticians, but I tell you, in-rhythm analysis is really a better way to look at it for the clinician,” Dr. Singh said.
David S. Cannom, M.D., commented that the SAFE-T findings are consistent with the general anecdotal experience, which says that most patients tend to feel better when in sinus rhythm than in atrial fibrillation.
The SAFE-T data “certainly strike me as closer to what we see in practice on a daily basis,” added Dr. Cannom, director of cardiology at Good Samaritan Hospital, Los Angeles, and a past president of the Heart Rhythm Society.