Bare Metal Versus Paclitaxel-Eluting Stents for Long Femoropopliteal Lesions: Prospective Cohorts Comparison Using a Propensity Score-Matched Analysis.

Background: The study aims to compare outcomes of primary stenting of long femoropopliteal (FP) lesions with bare metal stent (BMS) versus paclitaxel eluting stent (PES).

Methods: In a single centre study, we established 2 consecutive and prospective cohorts with TASC C/D FP de novo lesions. The inclusion and exclusion criteria were similar. Bare metal stent (LifeStent, Bard Peripheral) and PES (Zilver PTX, Cook Peripheral Vascular) were implanted. Prospective clinical and morphological follow-ups were carried out at 1, 3, 6, 12, and 18 months. Propensity score (inverse probability of treatment weighted method) stratification was used to minimize bias.

Results: In total, 110 limbs were treated (STELLA: n = 62; STELLA PTX: n = 48). We noted some difference between both cohorts regarding type 2 diabetes (P = 0.05), vitamin K antagonist use (P = 0.05), and angiotensin II receptor blocker use (P = 0.002). More stents were implanted in the STELLA PTX cohort (P < 0.0013). At 12 months, in univariate analysis, freedom from target lesion revascularization (TLR) was higher in the STELLA cohort (P = 0.005). No differences were found between both cohorts in terms of primary sustained clinical improvement (P = 0.25), primary patency (P = 0.07), and survival (P = 0.79). With the propensity score, no difference was observed in terms of primary sustained clinical improvement (P = 0.79), freedom from TLR (P = 0.59), and primary patency (P = 0.69). With Cox logistic regression, the number of implanted stents influenced the primary sustained clinical improvement, the freedom from TLR, and the primary patency.

Conclusions: Paclitaxel-eluting stents do not seem to provide benefits in terms of clinical and morphological outcomes for TASC C/D lesions compared to BMS.