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 evidence High 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.