One-Year Late Lumen Loss between A Polymer-Coated Paclitaxel-Eluting Stent (Eluvia) and a Polymer-Free Paclitaxel-Coated Stent (Zilver PTX) for Femoropopliteal Disease

Abstract

Aim: Paclitaxel-eluting stents' (Eluvia and Zilver PTX) effectiveness has been recently reported for femoropopliteeal (FP) lesions. However, there is no evaluation of one-year late lumen loss (LLL). Therefore, we evaluated one-year LLL after implantation with Eluvia or Zilver PTX.Methods: This was a multicenter, prospective study. Patients who had symptomatic de novo lesions in the native FP artery were enrolled. The primary endpoint was one-year angiographic LLL, and the secondary endpoints were binary restenosis and target lesion revascularization (TLR) at one year.Results: From December 2015 to December 2016, 48 patients (Eluvia, 36 patients; Zilver PTX, 12 patients) were enrolled. No significant difference was found in baseline and lesion characteristics between both groups. One-year, LLL was significantly lower in the Eluvia group (0.60 {plus minus}0.80 mm) than in the Zilver PTX group (1.74 {plus minus}0.89 mm) (P = 0.0003). Negative LLL was observed only in the Eluvia group (0% vs. 23%, p = 0.096). The binary restenosis rate was significantly lower than in the Zilver PTX group (0% vs. 16.7%, P = 0.012). The one-year TLR in the Eluvia group tended to be lower (0% vs. 8.3%, P = 0.08). Stent thrombosis was not observed in either group.Conclusion: One-year LLL in the Eluvia group was significantly lower than that in the Zilver PTX group for FP lesions.