Efficacy of Pacitaxel-Eluting Stents in Femoropopliteal Disease: A Systematic Review and Meta-Analysis

Drug-eluting stents (DESs) are increasingly used in femoropopliteal interventions, but the comparative effectiveness of polymer-based paclitaxel-eluting stents relative to bare-metal stents (BMSs), drug-coated balloons (DCBs), and other platforms remains uncertain. This study aimed to evaluate the efficacy and safety of polymer-based paclitaxel-eluting stents compared with alternative endovascular devices.

A systematic review and meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Thirteen comparative studies (7 randomized trials and 6 observational cohorts), including 5,544 patients, were analyzed. Comparators included Zilver paclitaxel-eluting stent (PTX), bare-metal stents (BMS), drug-coated balloons (DCB), Viabahn stent graft, and Supera. The primary outcome was restenosis or target lesion revascularization at 12-60 months. Random-effects models were applied, and heterogeneity, bias, and robustness were assessed with I², funnel, Galbraith, and L'Abbé plots, as well as Egger's and trim-and-fill analyses.

Polymer-based paclitaxel-eluting stents were associated with lower rates of restenosis and reintervention compared with alternative devices (odds ratio: 0.56; 95% confidence interval: 0.44-0.71; P < 0.001). Effects varied according to comparator type, and several individual studies reported numerical rather than statistically significant differences. Heterogeneity was moderate (I² = 59%), largely related to study design and follow-up duration. No publication bias was detected (Egger's P = 0.22), and sensitivity analyses supported the overall direction of effect.

Polymer-based paclitaxel-eluting stents appear to provide favorable midterm outcomes compared with BMS, Zilver PTX, DCB, and other platforms. These results support their use as a valuable option for femoropopliteal revascularization, although clinical heterogeneity and the inclusion of retrospective studies underscore the need for individualized device selection.