DIAMOND 2001.
Methods | RCT Double‐blind Loss to follow‐up reported: yes |
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Participants | Persistent AF (mean duration: NS) in people with heart failure or recent myocardial infarction and reduced LVEF. n = 506 Men: 77% Age (mean): 72 (range 36–92) years Structural heart disease: 100%. LAD: NS. LVEF: NS, all < 35% |
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Interventions | Dofetilide 500 µg/day vs placebo Method of AF cardioversion: spontaneous or pharmacological 63%, electrical 37% Warfarin discretionary |
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Outcomes | At 12 and 24 months: Mortality Proarrhythmia Heart failure AF recurrence |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence. |
Allocation concealment (selection bias) | Low risk | Allocation by a central office after inclusion. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind study using matching placebo. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No participant was lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All outcomes prespecified and all expected outcomes of interest were well reported. Members of an events committee reviewed available data on a blinded basis and classified deaths. |
Other bias | Unclear risk | Substudy from the 2 DIAMOND RCTs which were not stratified by rhythm. |