Carunchio 1995.
Methods | RCT Open‐label Loss to follow‐up reported: yes |
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Participants | Recurrent AF (type: NS) with > 3 episodes in previous 1 year. NS. n = 66 Men: 50% Age (mean): 48 (range 30–69) years Structural heart disease: 65%. LAD: 36 mm. LVEF: NS, all > 40% |
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Interventions | Flecainide 200 mg/day vs sotalol 240 mg/day vs placebo Method of AF cardioversion: pharmacological 67%, electrical 33% Warfarin discretionary |
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Outcomes | At 12 months: Mortality Stroke Proarrhythmia Adverse effects AF recurrence |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were "randomly allocated", but the procedure was not described. |
Allocation concealment (selection bias) | Unclear risk | The procedure to conceal allocations was not described. |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinding described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants loss to follow‐up. |
Selective reporting (reporting bias) | Low risk | All study's prespecified outcomes of interest were reported. All main outcomes expected were reported. |
Other bias | Low risk | No other bias apparent. |