Summary of findings for the main comparison. Statin versus Placebo for aortic valve stenosis.
| Statin versus Placebo for aortic valve stenosis | |||||
| Patient or population: patients with aortic valve stenosis Settings: Outpatients and hospitalisation Intervention: Statin versus Placebo | |||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | |
| Assumed risk | Corresponding risk | ||||
| Placebo | Statin | ||||
|
Mean pressure gradient (mmHg) Better indicated by lower scores. Follow‐up: median 2.4 to 4.5 years |
The mean mean pressure gradient in the control groups was 34 to 35 mmHg | The mean mean pressure gradient in the intervention groups was 0.54 lower (1.88 lower to 0.8 higher) | MD ‐0.54 (‐1.88 to 0.80) | 1935 (2 studies) | ⊕⊕⊝⊝ low1,2 |
|
Valve area (cm2)
Better indicated by higher scores. Follow‐up: median 2.4‐ to 3.5 years |
The mean valve area in the control groups was 1 to 1.5 cm2 | The mean valve area in the intervention groups was 0.07 lower (0.28 lower to 0.14 higher) | MD ‐0.07 (‐0.28 to 0.14) | 127 (2 studies) | ⊕⊕⊝⊝ low2,3 |
| Aortic jet velocity (m/s) Follow‐up: median 2.1 years | The mean aortic jet velocity in the control groups was 3.45 m per second | The mean aortic jet velocity in the intervention groups was 0.06 lower (0.26 lower to 0.14 higher) | MD ‐0.06 (‐0.26 to 0.14) | 155 (1 study) | ⊕⊕⊝⊝ low2,3 |
| Freedom from valve replacement Follow‐up: median 2.1 to 4.5 years | Study population | RR 0.93 (0.81 to 1.06) | 2360 (4 studies) | ⊕⊕⊕⊝ moderate2 | |
| 281 per 1000 | 261 per 1000 (227 to 298) | ||||
| Moderate population | |||||
| 222 per 1000 | 206 per 1000 (180 to 235) | ||||
| Death from cardiovascular cause Follow‐up: median 2.1 to 4.5 years | Study population | RR 0.80 (0.56 to 1.15) | 2297 (3 studies) | ⊕⊕⊝⊝ low2,4 | |
| 56 per 1000 | 45 per 1000 (31 to 64) | ||||
| Moderate population | |||||
| 39 per 1000 | 31 per 1000 (22 to 45) | ||||
| Hospitalisation for any reason Follow‐up: median 2.1 years | 154 per 1000 | 129 per 1000 (60 to 283) | RR 0.84 (0.39 to 1.84) | 155 (1 study) | ⊕⊝⊝⊝ very low2,3,4 |
| Adverse events ‐ Muscle pain Follow‐up: median 2.4 to 4.5 years | Study population | RR 0.91 (0.75 to 1.09) | 2204 (3 studies) | ⊕⊕⊕⊝ moderate2 | |
| 168 per 1000 | 153 per 1000 (126 to 183) | ||||
| Moderate population | |||||
| 30 per 1000 | 27 per 1000 (22 to 33) | ||||
| *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. | |||||
1 Downgraded by one due to randomisation and allocation being unclear for Rossebø 2008. 2 Downgraded by one due to possible risk of publication bias as only a small number of studies were identified. 3 Downgraded by one due to imprecision: small sample size with effect size crossing the line of no effect. 4 Downgraded by one due to imprecision: very few events < 300.