Comparative Analysis of Three Year Results of Two Paclitaxel Related Stents for the Management of Femoropopliteal Disease in a Real World Setting.

Abstract

Objective: Randomised clinical trials have demonstrated superiority of the Eluvia stent over Zilver PTX for femoropopliteal artery disease in terms of one and two year clinical outcomes, but comparative real world data beyond two years are not available. This study aimed to compare Zilver PTX and Eluvia stents and reports three year primary patency, patient outcomes, and safety results from the REALDES study.

Methods: The REALDES study was a prospective, multicentre, observational study that enrolled adult patients with symptomatic femoropopliteal disease scheduled for treatment with either Zilver PTX or Eluvia. This study included patients with native femoropopliteal artery disease treated with Zilver PTX (n = 96 limbs) or Eluvia (n = 104 limbs). The primary outcome was three year primary patency, and secondary outcomes included freedom from clinically driven target lesion revascularisation (TLR) and Tosaka classification.

Results: The baseline characteristics were comparable between the Zilver PTX and Eluvia groups, apart for longer lesion lengths in the Zilver PTX group. At three years, the primary patency rates were 70.0% for Zilver PTX and 65.2% for Eluvia, with no significant difference (p = .74). Furthermore, there are no significant differences between the two stents at one and two years. Freedom from TLR rates were 79.4% for Zilver PTX and 76.3% for Eluvia, with no significant difference (p = .27). the incidence of Tosaka class III was 7.3% in the Zilver PTX group and 14.4% in the Eluvia group at three years (p = .10). Among patients with re-stenosis, the incidence of in stent occlusion was significantly higher with Eluvia (57.7%) than with Zilver PTX (29.2%) (p = .041). No baseline characteristics were associated with the three year re-stenosis risk.

Conclusion: Zilver PTX and Eluvia stents demonstrated comparable primary patency and freedom from clinically driven TLR after three years in real world femoropopliteal artery interventions. In routine clinical practice, Eluvia should be used judiciously in backgrounds with a high risk of re-stenosis.