Flec‐SL 2012.
Methods | RCT Open‐label Loss to follow‐up reported: yes |
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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 |
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Interventions | Flecainide 200–300 mg/day vs no treatment Method of AF cardioversion: pharmacological 20%, electrical 80% Warfarin discretionary |
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Outcomes | At 6 months: Mortality Proarrhythmia Stroke, embolism AF recurrence |
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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. |