Summary of findings 9. Sotalol compared to placebo or no treatment for maintaining sinus rhythm after cardioversion of atrial fibrillation.
| Sotalol 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: sotalol 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 sotalol | |||||
| All‐cause mortality follow‐up: range 6–12 months | Study population | RR 2.23 (1.03 to 4.81) | 1882 (5 RCTs) | ⊕⊕⊕⊕ High | — | |
| 8 per 1000 | 19 per 1000 (9 to 40) | |||||
| Withdrawals due to adverse effects follow‐up: range 6–19 months; median 12 months | Study population | RR 1.95 (1.23 to 3.11) | 2688 (12 RCTs) | ⊕⊕⊕⊝ Moderatea,b,c | Heterogeneity was high for the main analysis (I2 = 56%), but the test for subgroup differences indicated that the RR was higher in older studies with sotalol. | |
| 94 per 1000 | 183 per 1000 (116 to 293) | |||||
| Proarrhythmia follow‐up: median 12 months | Study population | RR 3.55 (2.16 to 5.83) | 2989 (12 RCTs) | ⊕⊕⊕⊝ Moderatea,c | — | |
| 12 per 1000 | 41 per 1000 (25 to 68) | |||||
| Stroke follow‐up: range 6–12 months | Study population | RR 1.47 (0.48 to 4.51) | 1161 (3 RCTs) | ⊕⊕⊕⊝ Moderated | — | |
| 7 per 1000 | 10 per 1000 (3 to 30) | |||||
| Recurrence of atrial fibrillation follow‐up: range 6–19 months; median 12 months | Study population | RR 0.83 (0.80 to 0.87) | 3179 (14 RCTs) | ⊕⊕⊕⊕ Higha,e,f | — | |
| 78.8 per 100 | 65.4 per 100 (63.1 to 68.6) | |||||
| *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. | ||||||
aNot downgraded for study limitations. Although the majority of studies had unclear or high risk of bias in at least one of the key domains, the majority of the weight was from studies at low risk of bias in key domains. bNot downgraded for inconsistency. I2 statistic was 56% for the main analysis, but this was partially explained by subgroup analysis. cDowngraded one level for publication bias: forest plot appeared to be asymmetrical. dDowngraded one level for imprecision: confidence interval included both possible benefit and harm. eNot downgraded for publication bias: funnel plot appears to be broadly symmetrical. fNot downgraded for inconsistency. I2 statistic was 54% but the forest plot had good overlap in confidence intervals, so a fixed‐effect model was used to maintain the weight of the few larger studies.