Summary of findings 1. Atherectomy compared to balloon angioplasty for peripheral arterial disease.
Atherectomy compared to BA for PAD | |||||
Patient or population: people with PAD Setting: hospital Intervention: atherectomy Comparison: BA | |||||
Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
Risk with BA | Risk with atherectomy | ||||
Primary patency (follow‐up: 6 months) |
186 (3 RCTs) | ⊕⊝⊝⊝ VERY LOWa | RR 1.06 (0.94 to 1.20) | Study population | |
575 per 1000 | 609 per 1000 (540 to 690) | ||||
Primary patency (follow‐up: 12 months) |
149 (2 RCTs) | ⊕⊝⊝⊝ VERY LOWa | RR 1.20 (0.78 to 1.84) | Study population | |
671 per 1000 | 805 per 1000 (524 to 1000) | ||||
Mortality (follow‐up: 12 months) |
210 (3 RCTs) | ⊕⊝⊝⊝ VERY LOWa | RR 0.50 (0.10 to 2.66) | Study population | |
102 per 1000 | 51 per 1000 (10 to 271) | ||||
Fatal and non‐fatal cardiovascular events (follow‐up: 24 months) |
160 (2 RCTs) | ⊕⊝⊝⊝ VERY LOWa | — | Zeller 2017 reported cardiac failure and acute coronary syndrome as causes of death at 24 months, but it was unclear for which participants in which arms this was accountable for. Shammas 2011 declared embolic stroke and myocardial infarction to be secondary outcomes, but no events were recorded in either arm | |
TVR (follow‐up: 6 months) |
136 (2 RCTs) | ⊕⊝⊝⊝ VERY LOWa | RR 0.51 (0.06 to 4.42) | Study population | |
70 per 1000 | 36 per 1000 (4 to 311) | ||||
TVR (follow‐up: 12 months) |
176 (3 RCTs) | ⊕⊝⊝⊝ VERY LOWa | RR 0.59 (0.25 to 1.42) | Study population | |
140 per 1000 | 82 per 1000 (35 to 198) | ||||
Complication rates (follow‐up: 12 months) |
387 (6 RCTs) | ⊕⊝⊝⊝ VERY LOWa | RR 0.69 (0.28 to 1.68) |
Study population | |
219 per 1000 | 151 per 1000 (61 to 367) | ||||
*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). BA: balloon angioplasty; CI: confidence interval; PAD: peripheral arterial disease; RR: risk ratio; TVR: target vessel revascularisation | |||||
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 |
a We downgraded by three steps due to risk of bias (lack of blinding and high rates of attrition); imprecision (small trials with few participants and events); and inconsistency (heterogeneity).