SAFIRE‐D 2000.
Methods | RCT Double‐blind Loss to follow‐up reported: yes |
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Participants | Persistent AF or AFl lasting 2 weeks to 6 months (mean duration: NS). n = 250 Men: 84% Age (mean): 67 (range 30–88) years Structural heart disease: 67%. LAD: NS. LVEF: NS |
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Interventions | Dofetilide various doses (250 µg/day, 500 µg/day and 1000 µg/day) vs placebo Method of AF cardioversion: pharmacological 15%, electrical 85% Warfarin discretionary |
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Outcomes | At 12 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 of randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | Method of concealment not described. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Reported as "double blind", but details on the procedure employed were not given. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals and dropouts were well detailed, not many and balanced between groups. |
Selective reporting (reporting bias) | Low risk | All prespecified and expected outcomes of interest were well described. |
Other bias | Low risk | No other bias apparent. |