Beneficial Effect of Flecainide Controlled Release on the Quality of Life of Patients with Atrial Fibrillation-the REFLEC-CR Study.

ABSTRACT

PURPOSE: Atrial fibrillation (AF) is the most common cardiac arrhythmia with a considerable impact on patients' quality of life (QoL). METHODS: This prospective, multicenter, observational study aimed to evaluate the effect of oral treatment with controlled-release (CR) flecainide on AF patients' QoL and treatment compliance during a 12-week period. A total of 70 sites enrolled consecutive patients with paroxysmal (PAF) or persistent AF (PerAF), treated with flecainide CR in the context of a rhythm control strategy. The effect on QoL was assessed by the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale (CCS-SAF). RESULTS: In total, 679 patients (53.2% females, 66 ± 11.7 years, 86.9% PAF) were included. Prior antiarrhythmic medication had been administered in 43.8% of patients. A daily dose of 200 mg was administered to 66.4% of patients by the end of study. Flecainide CR resulted in a significant reduction in the CCS-SAF score (mean (SD)) at the end of the study as compared with baseline (1.32 (0.57) vs 1.64 (0.73), p < 0.0001). Flecainide CR significantly reduced the CCS-SAF score both in PAF (1.27 (0.52) vs 1.61 (0.72), p < 0.0001) as well as in PerAF (1.63(0.77) vs 1.84(0.81), p = 0.017). Overall, 4 (0.6%) patients experienced a total of 6 adverse events during the study period. The compliance to flecainide CR treatment was very high with 93.6% of patients responding that they had not missed any dose during the study period. CONCLUSION: Treatment with flecainide CR significantly improves QoL in both paroxysmal as well as persistent AF patients, with an excellent safety profile and associated patient compliance.