D. George Wyse, MD, PhD, FRCPC, FACP
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?
Randomized controlled noninferiority trial (Flecainide Short-Long [Flec-SL] trial). Current Controlled Trials ISRCTN 62728742.
Blinded* (primary outcome assessors).
4 weeks and 6 months.
44 centers in Germany.
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.
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.
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).
95% included in the primary per-protocol analysis.
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).
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‡
‡AF = atrial fibrillation; CI defined in Glossary.
§No deaths occurred.
||Per-protocol analysis. Noninferiority criterion (upper bound of CI ≤ 12%) was not met.
Wyse DG. Short-term was less effective than long-term flecainide for preventing recurrent AF after cardioversion. Ann Intern Med. ;157:JC3–9. doi: 10.7326/0003-4819-157-6-201209180-02009
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Published: Ann Intern Med. 2012;157(6):JC3-9.
Cardiology, Rhythm Disorders and Devices.
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