Paving the Way: a Systematic Review and Meta-Analysis of Randomized Controlled Trials of Atherectomy as Vessel Preparation Prior to Balloon Angioplasty in Peripheral Arterial Disease.

PURPOSE: This systematic review and meta-analysis compares the safety and efficacy of atherectomy as a vessel preparation tool prior to balloon angioplasty (ATH + BA) versus balloon angioplasty alone (BA) for the treatment of peripheral arterial disease (PAD).

MATERIALS AND

METHODS

Medline, Embase, CENTRAL, and Clinicaltrials.gov databases were searched for randomized controlled trials (RCTs) comparing ATH + BA versus BA alone in treating PAD. The outcomes analysed included primary patency, technical success, bailout stenting, flow-limiting dissection, clinically driven target lesion revascularization (CD-TLR), distal embolization, arterial perforation, major amputation, and all-cause mortality. A subgroup analysis was done to compare femoropopliteal versus infrapopliteal and plain balloon angioplasty versus drug-coated balloon.

RESULTS

Seven RCTs met the inclusion criteria (489 patients). Atherectomy as vessel preparation was associated with reduced rates of bailout stenting (OR: 0.14, 95% CI 0.03-0.67, p = 0.01) and flow-limiting dissection (OR: 0.29, 95% CI 0.10-0.84, p = 0.02). Primary patency (OR: 2.13, 95% CI 1.00-4.50, p = 0.049) and CD-TLR at 6 months (OR: 0.24, 95% CI 0.06-0.96, p = 0.04) results favoured ATH + BA. No significant differences were found in technical success, 12-month primary patency, CD-TLR at 12 months, distal embolization, arterial perforation, major amputation, or all-cause mortality. Subgroup analysis demonstrated a reduction in bailout stenting in femoropopliteal studies (OR: 0.05, 95% CI 0.01-0.21) compared with infrapopliteal studies (OR: 0.86, 95% CI 0.31-2.40).

CONCLUSIONS

This meta-analysis found that atherectomy as vessel preparation prior to BA reduced bailout stenting, flow-limiting dissections, and 6-month CD-TLR, with improved 6-month patency compared with BA alone. However, these benefits did not translate into improvements in clinical outcomes at 12 months. Larger RCTs are needed to establish the clinical benefit of atherectomy.