REALDES Study Compares Zilver PTX and Eluvia Drug-Eluting Stents at 3 Years

March 27, 2025—Investigators seeking to compare real-world outcomes with drug-eluting stents (DES) in symptomatic femoropopliteal lesions have shared results from REALDES, a prospective multicenter observational study. Published in European Journal of Vascular & Endovascular Surgery, Shibata et al enrolled 200 limbs treated with either the Zilver PTX (Cook Medical) or Eluvia (Boston Scientific Corporation) DES and followed them out to 3 years. The investigators reported no significant differences in primary patency rates or freedom from clinically driven target lesion revascularization (CD-TLR), but noted differences in the rates of in-stent occlusions.

Patients were enrolled at eight centers in Japan between February 2019 and September 2020, with 96 limbs receiving Zilver PTX and 104 limbs treated with Eluvia. The primary outcome measure was primary patency at 3 years, with secondary outcomes including freedom from CD-TLR and Tosaka classification. Baseline characteristics were similar across the groups, with the exception of longer lesions in the Zilver PTX arm (185.7 ± 92 mm vs 160 ± 99 mm for Eluvia). The rate of follow-up at 3 years was 47.5%.

Key findings from REALDES include comparable estimated 3-year patency rates—70% for Zilver PTX versus 65.2% for Eluvia (P = .74), with no significant differences also seen at 1- and 2-year follow-up. Freedom from CD-TLR was similar among the two groups (79.4% for Zilver PTX vs 76.3% for Eluvia; P = .27). In the secondary outcomes focusing on restenosis, the rate of Tosaka class III was 7.3% (7/96) in limbs treated with Zilver PTX versus 14.4% (15/104) with Eluvia at 3 years (P = .10). The investigators noted that in cases with restenosis, the incidence of stent occlusion was significantly higher with Eluvia (57.7% [15/26]) than with Zilver PTX (29.2% [7/24]), respectively (P = .041). No baseline characteristics were determined to be associated with 3-year restenosis risk.

In terms of the study’s limitations, the investigators noted its being nonrandomized and the limited number of patients; the lack of core laboratory review of angiographic evaluation of the initial procedure and Doppler ultrasound restenosis assessment were also described, although balanced with the assertion that all participating sites have substantial clinical study experience. There was no funding support for the study, and the investigators reported no conflicts of interest.

The trialists concluded that these long-term clinical outcomes are important for guiding stent selection in daily practice, and that further clinical evidence from real-world data is needed.