Comparative Efficacy of Endovascular Revascularization Modalities for Symptomatic Infrapopliteal Peripheral Artery...

Patients with infrapopliteal peripheral artery disease (PAD) are at elevated risk for amputation and mortality. The comparative efficacy of available endovascular devices for treating infrapopliteal PAD is unknown.

The aim of this study was to compare the efficacy of percutaneous transluminal angioplasty (PTA), bare-metal stents (BMS), drug-coated balloons (DCBs), and drug-eluting stents (DES), including bioresorbable DES, in patients with symptomatic infrapopliteal PAD.

Online databases were searched for published randomized controlled trials comparing PTA, BMS, DCB, and DES in patients with infrapopliteal PAD. Random-effects models were used to estimate ORs for binary variables and mean differences (MDs) for continuous variables.

Twenty-one randomized controlled trials comprising 2,958 patients were included (PTA, n = 1,102; BMS, n = 284; DCBs, n = 903; DES, n = 695). Compared with PTA, both DCBs and DES had higher primary patency (DCB OR: 2.66 [95% CI: 1.52-4.64; P = 0.001]; DES OR: 2.41 [95% CI: 1.23-4.73; P = 0.01]) and lower target lesion binary (>50%) restenosis (DCB OR: 0.40 [95% CI: 0.21-0.77; P = 0.006]; DES OR: 0.28 [95% CI: 0.13-0.62; P = 0.002]). DCBs also lowered late lumen loss (MD: 0.34; 95% CI: -0.63 to -0.05; P = 0.02), in-lesion diameter stenosis (MD: -10.04; 95% CI: -19.20 to -0.88; P = 0.03), and clinically driven target lesion revascularization (OR: 0.47; 95% CI: 0.29-0.76; P = 0.002). Conversely, BMS decreased the odds of complete wound healing (OR: 0.41; 95% CI: 0.20-0.85; P = 0.02). No significant differences in amputation or mortality were observed across the 4 comparator groups.

Compared with PTA, DCBs and DES demonstrated higher primary patency and lower binary restenosis, and DCBs reduced late lumen loss, percentage in-lesion diameter stenosis, and clinically driven target lesion revascularization.