Summary of findings 1. EDTA compared to placebo for atherosclerotic cardiovascular disease.
EDTA compared to placebo for atherosclerotic cardiovascular disease | ||||||
Patient or population: atherosclerotic cardiovascular disease Setting: outpatient clinics Intervention: EDTA Comparison: placebo | ||||||
Outcomes | No. of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Comments | |
Risk with placebo | Risk difference with EDTA | |||||
All‐cause mortality follow up: range 1 years to 5 years | 1792 (2 RCTs) | ⊕⊕⊝⊝ LOW a,b | RR 0.97 (0.73 to 1.28) | Study population | Two studies with coronary artery disease participants | |
102 per 1000 | 3 fewer per 1000 (28 fewer to 29 more) | |||||
Coronary heart disease death follow up: mean 5 years | 1708 (1 RCT) | ⊕⊝⊝⊝ VERY LOW c,d | RR 1.02 (0.70 to 1.48) | Study population | One study with coronary artery disease participants | |
59 per 1000 | 1 more per 1000 (18 fewer to 28 more) | |||||
Myocardial infarction follow up: range 1 years to 5 years | 1792 (2 RCTs) | ⊕⊕⊕⊝ MODERATE e | RR 0.81 (0.57 to 1.14) | Study population | Two studies with coronary artery disease participants | |
75 per 1000 | 14 fewer per 1000 (32 fewer to 10 more) | |||||
Angina follow up: range 1 years to 5 years | 1792 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW e,f,g | RR 0.95 (0.55 to 1.67) | Study population | Two studies with coronary artery disease participants | |
26 per 1000 | 1 fewer per 1000 (12 fewer to 18 more) | |||||
Stroke follow up: range 6 months to 5 years | 1867 (2 RCTs) | ⊕⊕⊝⊝ LOW e,h | RR 0.88 (0.40 to 1.92) | Study population | One study with coronary artery disease participants and one study with peripheral vascular disease participants | |
14 per 1000 | 2 fewer per 1000 (9 fewer to 12 more) | |||||
Ankle‐brachial pressure index at 3 months post‐treatment | 181 (2 RCTs) | ⊕⊕⊝⊝ LOW e,h | ‐ | The mean ankle‐brachial pressure index at 3 months post‐treatment was 0.56. | MD 0.02 higher (0.03 lower to 0.06 higher) | Two studies with peripheral vascular disease participants |
Maximum walking distance (m) at 3 months post‐treatment | 165 (2 RCTs) | ⊕⊕⊝⊝ LOW e,h | ‐ | The mean maximum walking distance (m) at 3 months post‐treatment was 112.5. | MD 31.46 m lower (87.63 lower to 24.71 higher) | Two studies with peripheral vascular disease participants |
*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; EDTA: ethylene diamine tetra‐acetic acid; RCT: randomised controlled trials; 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 |
aDowngrade 1 level: death rates very different between two studies reporting. bDowngrade 1 level: only one of two studies in the meta‐analysis provided events for this outcome, making the estimate imprecise. cDowngrade 1 level: only one study reporting on this outcome so cannot evaluate inconsistency. dDowngrade 2 levels: only one study included in this analysis and the confidence intervals are very wide. eDowngrade 1 level: very wide confidence interval around point estimate makes it difficult to interpret true association. fDowngrade 1 level: two studies included in analysis are seemingly consistent but variability is 35%, indicating moderate heterogeneity. gDowngrade 1 level: two studies reporting on this outcome use different definitions and methods to determine angina. hDowngrade 1 level: one included study had a high risk of bias that might have affected the outcome assessment.