Abstract
BACKGROUND: 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.
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.