Summary of findings for the main comparison. Statins compared to control at 4 months (3 to 6 months) for acute coronary syndrome.
| Statins compared to control at 4 months (3 to 6 months) for acute coronary syndrome | ||||||
| Patient or population: patients with acute coronary syndrome Settings: inpatients, developed countries Intervention: statins Comparison: control at 4 months (3 to 6 months) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control at 4 months (3 to 6 months) | Statins | |||||
| Combined outcome of non‐fatal myocardial infarction, non‐fatal stroke, and total number of deaths Follow‐up: 3 to 6 months | 80 per 10001 | 75 per 1000 (65 to 85) | RR 0.93 (0.81 to 1.06) | 9625 (11 studies) | ⊕⊕⊕⊝ moderate2,3 | |
| Death from all causes Follow‐up: 3 to 6 months | 28 per 10001 | 25 per 1000 (20 to 32) | RR 0.9 (0.7 to 1.14) | 9733 (12 studies) | ⊕⊕⊕⊝ moderate2,3 | |
| Fatal and non‐fatal myocardial infarction or reinfarction Follow‐up: 3 to 6 months | 65 per 10001 | 59 per 1000 (50 to 69) | RR 0.91 (0.77 to 1.06) | 9537 (10 studies) | ⊕⊕⊕⊝ moderate2,3 | |
| Fatal and non‐fatal stroke Follow‐up: 3 to 6 months | 10 per 10001 | 7 per 1000 (4 to 11) | RR 0.72 (0.45 to 1.16) | 8536 (7 studies) | ⊕⊕⊕⊝ moderate2,3 | |
| Unstable angina Follow‐up: 3 to 6 months | 63 per 10001 | 48 per 1000 (37 to 60) | RR 0.76 (0.59 to 0.96) | 8770 (9 studies) | ⊕⊕⊕⊝ moderate2,4 | |
| Acute heart failure Follow‐up: mean 4 months | 26 per 10001 | 22 per 1000 (17 to 30) | RR 0.86 (0.65 to 1.15) | 7583 (2 studies) | ⊕⊕⊕⊝ moderate3 | |
| Rhabdomyolysis Follow‐up: mean 4 months | 0 per 10001 | 0 per 1000 (0 to 0) | RR 6.9 (0.36 to 133.47) | 4497 (1 study) | ⊕⊕⊝⊝ low5 | |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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; RR: risk ratio | ||||||
| GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | ||||||
1The basis of the assumed risk is the average risk of control group patients. 2The largest studies had allocation concealment and used blinding for patients, caregivers, and outcome assessors; however for many studies allocation concealment remained unclear and almost half were open‐label. Sensitivity analyses with high quality studies did not change the point estimate. 3The CI includes effects suggesting benefit as well as no benefit, therefore we decided to downgrade by one level when considering this imprecision together with some concerns about risk of bias. 4There is moderate heterogeneity among studies included in the analysis of unstable angina at four months (I² = 33%). The subgroup analysis for trials with blinded outcome assessment (because of possible subjective component for diagnosis of unstable angina) was still statistically significant, but the estimated risk reduction was smaller. Overall we decided to downgrade by one level when considering the heterogeneity and remaining concerns about the risk of bias. 5The CI includes the possibility of both harms or benefits and there are only three events of rhabdomyolysis in total; therefore we decided to downgrade by two levels for imprecision.