Skip to main content
. 2019 Sep 4;2019(9):CD005049. doi: 10.1002/14651858.CD005049.pub5

Flec‐SL 2012.

Methods RCT
Open‐label
Loss to follow‐up reported: yes
Participants Persistent AF with indication for cardioversion (mean duration: 20 months). n = 362
Men: 66%
Age (mean): 64 (SD 10) years
Structural heart disease: NS
LAD: 46 mm. LVEF: NS
Interventions Flecainide 200–300 mg/day vs no treatment
Method of AF cardioversion: pharmacological 20%, electrical 80%
Warfarin discretionary
Outcomes At 6 months:
Mortality
Proarrhythmia
Stroke, embolism
AF recurrence
Notes A third group of participants randomised to flecainide for only 3 months was not included in the review.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers table.
Allocation concealment (selection bias) Low risk Allocation by a distant central office.
Blinding (performance bias and detection bias) 
 All outcomes High risk Open‐label trial.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All withdrawals and dropouts of participants well described. Missing outcome data balanced across intervention groups.
Selective reporting (reporting bias) Low risk All of the study's prespecified outcomes were reported in the prespecified way.
Other bias Low risk No other bias apparent.