SAFE‐T 2005.
Methods | RCT Double‐blind Loss to follow‐up reported: yes |
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Participants | Persistent AF lasting 3 days to 1 year (mean duration: NS). n = 655 Men: 99% Age (mean): 67 (SD 9) years Structural heart disease: 33%. LAD: 48 mm. LVEF: 51% Type of AF: persistent, mean duration: NS |
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Interventions | Amiodarone 300 mg/day vs sotalol 320 mg/day vs placebo Method of AF cardioversion: pharmacological 20%, electrical 80% |
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Outcomes | At 12 months: Mortality Stroke Proarrhythmia 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, permuted‐block randomisation, with stratification. |
Allocation concealment (selection bias) | Low risk | Both the investigators and participants were unaware of the study‐group assignments. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind study, matching placebo. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals and lost to follow‐up were well balanced and described. |
Selective reporting (reporting bias) | Low risk | All prespecified and expected outcomes were adequately reported. |
Other bias | Low risk | No other bias apparent. |