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 (AF) were placed on amiodarone, sotalol, or placebo and followed for 1 year.
The primary SAFE-T results were recently published, showing that while amiodarone and sotalol were equally effective in converting AF 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 prior major randomized controlled trials—the AF Follow-Up Investigation of Rhythm Management (AFFIRM), Pharmacological Intervention in AF (PIAF), and Rate Control Versus Electrical Cardioversion (RACE)—had concluded there is little quality-of-life difference 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 group 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 follow-up.
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 AF in terms of these outcomes. At 1 year, for example, the sinus rhythm group fared significantly better than patients in AF 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.)
“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,” Dr. Singh said.
David S. Cannom, M.D., noted that the SAFE-T findings are consistent with the general anecdotal experience that most patients tend to feel better in sinus rhythm than in AF.
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.