Summary of findings 2. Atherectomy compared to balloon angioplasty with primary stenting for peripheral arterial disease.
| Atherectomy compared to BA and primary stenting for PAD | |||||
| Patient or population: people with PAD Setting: hospital Intervention: atherectomy Comparison: BA with primary stenting | |||||
| Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with BA with primary stenting | Risk with atherectomy | ||||
|
Primary patency (follow‐up 6 months) |
Not reported for this comparison | ||||
|
Primary patency (follow‐up 12 months) |
Not reported for this comparison | ||||
|
Mortality (follow‐up: 24 months) |
155 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa | RR 0.38 (0.04 to 3.23) | Study population | |
| 40 per 1000 | 15 per 1000 (2 to 129) | ||||
|
Fatal and non‐fatal cardiovascular events (follow‐up: 24 months) |
155 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa | RR 0.38 (0.04, 3.23) | Ott 2017 reported 4 deaths at 24 months (3 deaths in the drug‐eluting balloon and stent arm and 1 death in the plain balloon and stent arm) which they attributed to underlying cardiovascular disease, but no specific causes were stated. | |
|
TVR (follow‐up: 6 months) |
155 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa | RR 2.27 (0.95 to 5.46) | Study population | |
| 80 per 1000 | 182 per 1000 (76 to 437) | ||||
|
TVR (follow‐up: 24 months) |
155 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa | RR 2.05 (0.96 to 4.37) | Study population | |
| 240 per 1000 | 492 per 1000 (230 to 1000) | ||||
|
Complication rates (follow‐up: 24 months) |
155 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa | RR 7.04 (0.80 to 62.23) | Ott 2017 reported 3 complications, all 3 of which were in the atherectomy arm: 2 vessel perforations and 1 flow‐limiting dissection. | |
| *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 | |||||
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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 (inadequate blinding and high rates of attrition); and imprecision (small trial size, few participants and events, and wide confidence intervals).