DAPHNE 2008.
Methods | RCT Single‐blind Loss to follow‐up reported: yes |
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Participants | Bradycardia‐tachycardia sinus node disease with history of several episodes of AF or AFl and needing a pacemaker AF type: 100% paroxysmal. n = 135 Men: 49.6% Age (mean): 73 (SD 7) years Structural heart disease: 71%. LAD: 43 mm. LVEF: 56% |
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Interventions | Sotalol 167 mg/day (mean) vs beta‐blockers (atenolol or metoprolol) Method of AF cardioversion: 100% spontaneous Warfarin discretionary |
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Outcomes | At 19 months: 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 | High risk | Single‐blind study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Few participants were lost to follow‐up, were well balanced and well reported. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes of interest were reported. |
Other bias | Unclear risk | Restrictive inclusion criteria: only people with the bradycardia–tachycardia form of sinus node disease requiring pacemaker implantation were included. |