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Short-term was less effective than long-term flecainide for preventing recurrent AF after cardioversion.
MedLine Citation:
PMID:  22986401     Owner:  NLM     Status:  In-Data-Review    
QUESTIONS In adults with persistent atrial fibrillation (AF), is flecainide better than no antiarrhythmic drug therapy for preventing recurrent AF or death after cardioversion? Is short-term flecainide noninferior to long-term flecainide? METHODS DESIGN Randomized controlled noninferiority trial (Flecainide Short-Long [Flec-SL] trial). Current Controlled Trials ISRCTN 62728742. ALLOCATION Concealed.* BLINDING Blinded* (primary outcome assessors). FOLLOW-UP PERIOD 4 weeks and 6 months. SETTING 44 centers in Germany. PATIENTS 635 patients ≥ 18 years of age (mean age 64 y, 66% men) who had persistent electrocardiograph-confirmed AF and planned cardioversion that was successful. Exclusion criteria included use of other antiarrhythmic drugs for 5 half-lives before enrollment or amiodarone in the past 6 months. INTERVENTION Flecainide, 200 to 300 mg/d, for 4 weeks (short term, n = 273); flecainide for 6 months (long term, n = 281); or no antiarrhythmic drug therapy (control, n = 81). All patients received flecainide for ≥ 48 hours before cardioversion. OUTCOMES Primary outcome was a composite of recurrent persistent AF or death. Enrollment in the control group was stopped after a preplanned analysis at 4 weeks of follow-up. Noninferiority criterion was ≤ 12% absolute difference between short- and long-term flecainide for Kaplan-Meier point estimates of the primary outcome (1-sided α = 0.025). PATIENT FOLLOW-UP 95% included in the primary per-protocol analysis. MAIN RESULTS At 4 weeks, flecainide improved survival without recurrent AF more than no treatment (n = 242†, 70% vs 53%, P = 0.016). At 6 months, fewer patients in the short-term than the long-term flecainide group survived without recurrent AF; noninferiority criterion for short-term flecainide was not met in per-protocol (Table) or intention-to-treat analysis. Post hoc landmark analysis of the 62% of patients receiving flecainide without AF recurrence at 4 weeks found that long-term was better than short-term flecainide for preventing AF recurrence or death at 6 months (hazard ratio 0.31, 95% CI 0.18 to 0.56). CONCLUSION In adults with persistent atrial fibrillation, flecainide after cardioversion was better than no antiarrhythmic drug therapy for preventing recurrence; short-term flecainide was less effective than long-term flecainide.Flecainide for 4 wk vs 6 mo after cardioversion in patients with persistent AF‡OutcomeFlecainide for 4 wkFlecainide for 6 moAt 6 mo, difference (95% CI)Survival without recurrent AF§48%56%7.9% (-1.9 to 18)||‡AF = atrial fibrillation; CI defined in Glossary.§No deaths occurred.||Per-protocol analysis. Noninferiority criterion (upper bound of CI ≤ 12%) was not met.
D George Wyse
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Annals of internal medicine     Volume:  157     ISSN:  1539-3704     ISO Abbreviation:  Ann. Intern. Med.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-09-18     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372351     Medline TA:  Ann Intern Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  JC3-9     Citation Subset:  AIM; IM    
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