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

Summary of findings 6. Amiodarone compared to placebo or no treatment for maintaining sinus rhythm after cardioversion of atrial fibrillation.

Amiodarone compared to placebo or no treatment for maintaining sinus rhythm after cardioversion of atrial fibrillation
Patient or population: adults in sinus rhythm after cardioversion of atrial fibrillation
 Setting: hospital/community
 Intervention: amiodarone
 Comparison: placebo or no treatment
Outcomes Anticipated absolute effects* (95% CI) Relative effect
 (95% CI) № of participants
 (studies) Certainty of the evidence
 (GRADE) Comments
Risk with placebo or no treatment Risk with amiodarone
All‐cause mortality
 follow‐up: range 6–12 months Study population RR 1.66
 (0.55 to 4.99) 444
 (2 RCTs) ⊕⊕⊕⊝
 Moderatea
26 per 1000 43 per 1000
 (14 to 129)
Withdrawals due to adverse effects
 follow‐up: range 6–16 months Study population RR 6.70
 (1.91 to 23.45) 319
 (4 RCTs) ⊕⊕⊝⊝
 Lowb,c
7 per 1000 49 per 1000
 (14 to 172)
Proarrhythmia
 follow‐up: range 6–16 months Study population RR 2.22
 (0.71 to 6.96) 673
 (4 RCTs) ⊕⊕⊕⊝
 Moderatea,d
8 per 1000 18 per 1000
 (6 to 57)
Stroke
 follow‐up: mean 12 months Study population RR 1.15
 (0.30 to 4.39) 399
 (1 RCT) ⊕⊕⊝⊝
 Lowe
23 per 1000 26 per 1000
 (7 to 100)
Recurrence of atrial fibrillation
 follow‐up: median 12 months Study population RR 0.52
 (0.46 to 0.58) 812
 (6 RCTs) ⊕⊕⊕⊕
 Highd
81.2 per 100 42.2 per 100
 (37.3 to 47.1)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidenceHigh certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
 Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
 Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
 Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aDowngraded one level for imprecision: confidence interval included both possible benefit and harm.
 bDowngraded one level for study limitations: majority of weight was from studies with unclear or high risk of bias in key domains.
 cDowngraded one level for imprecision: small sample size.
 dNot downgraded for study limitations, as the majority weight was from studies at low risk of bias in all key domains.
 eDowngraded two levels for imprecision: small sample size and wide confidence interval which included both possible benefit and harm.