EMERALD 2000.
Methods | RCT Double‐blind Loss to follow‐up reported: yes |
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Participants | Persistent AF (1 week to 1 year, mean duration < 6 months). n = 535 Men: 70% Age (mean): 64 years Structural heart disease: NS. LAD: NS. LVEF: NS |
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Interventions | Dofetilide 250 µg/day, 500 µg/day or 1000 µg/day (3 different groups) vs sotalol 160 mg/day vs placebo Method of AF cardioversion: 10% pharmacological, 90% electrical Warfarin discretionary |
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Outcomes | At 12 months: Mortality Adverse effects Proarrhythmia AF recurrence |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of the method employed. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Presented as "double‐blind", but no detail given about how blinding was obtained. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals and dropouts were well detailed. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes are adequately reported. |
Other bias | Low risk | No other bias apparent. |