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. 2019 Sep 4;2019(9):CD005049. doi: 10.1002/14651858.CD005049.pub5

SAFIRE‐D 2000.

Methods RCT
Double‐blind
Loss to follow‐up reported: yes
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
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
Outcomes At 12 months:
Mortality
Proarrhythmia
Adverse effects
AF recurrence
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.