DAFNE 2003.
Methods | RCT Double‐blind Loss to follow‐up reported: no |
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Participants | Persistent AF (mean duration: 3 months). n = 199 Men: 70% Age (mean): 63 years Structural heart disease: NS. LAD: 45 mm. LVEF: 55% |
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Interventions | Dronedarone various doses (800 mg/day, 1200 mg/day, 1600 mg/day) vs placebo Method of AF cardioversion: pharmacological 15%, electrical 85% Warfarin discretionary |
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Outcomes | At 6 months: Mortality 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 | Method used for randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not detailed. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Reported as a double‐blind trial, but no details provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals because adverse events were reported, but other dropouts or lost to follow‐up were not well detailed. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes and main outcomes of interest were adequately reported. |
Other bias | Low risk | No other bias apparent. |