Bloomington, Ind. — Cook Medical’s Zilver PTX drug-eluting stent (DES) has lower rates of in-stent occlusions among patients with restenosis at three years than Boston Scientific’s Eluvia DES, according to real-world data from the REALDES study. The data, published by Tsuyoshi Shibata, M.D., Ph.D., et al., in the European Journal of Vascular & Endovascular Surgery (EJVES) are the first to compare Zilver PTX and Eluvia in real-world practice at three years.1 These data stand as another proof point of Cook’s relentlessly innovative products.
Zilver® PTX®, Cook Medical’s paclitaxel-coated stent
“There have been many unanswered questions on the reliability of the current data comparing the different drug-eluting stents on the market. REALDES helps paint a more complete picture on DES differences, evaluated by independent investigators in a real-world setting,” said Alec Cerchiari, director of product management for Cook’s PAD & Venous specialty. “We are grateful to the physicians and hospitals that participated in this study.”
REALDES is an investigator-initiated multicenter, prospective, observational study designed to compare Cook’s Zilver PTX DES and Boston Scientific’s Eluvia DES in a real-world setting for treating symptomatic femoropopliteal lesions. Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at eight Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at three years, defined as freedom from restenosis* or occlusion without reintervention.
Key three-year study outcomes include:
- There was no significant difference in primary patency (Zilver PTX, 70.0% vs. Eluvia, 65.2%; P = 0.74) or freedom from CD-TLR (79.4% vs. 76.3%; P = 0.27), despite the Zilver PTX arm having longer lesions (185.7 ± 92 mm vs. 160.0 ± 99 mm; P < .005).
- In patients with restenosis at three years, there was a significantly higher rate of in-stent occlusions (Tosaka class III2) for those treated with Eluvia (57.7%) compared to Zilver PTX (29.2%; P = 0.041).
“These findings contribute valuable insights into optimizing treatment outcomes and guiding future stent selection,” said lead author Dr. Shibata of Sapporo Medical University.
To learn more about Zilver PTX, visit Zilver PTX | Cook Medical.
About Cook Medical
At Cook Medical, we are passionate about making unique, quality medical devices and connecting with people to improve lives. Founded on inventing, manufacturing, and delivering medical devices, we provide healthcare professionals with the tools they need to help their patients return to living.
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*Restenosis was characterized as peak systolic velocity ratio > 2.4 based on the duplex ultrasonography findings or the recurrence of ≥50% diameter stenosis as determined by angiographic findings.
1 Shibata T, Iba Y, Shingaki M, et al. Comparative analysis of three-year results of two paclitaxel related stents for the management of femoropopliteal disease in a real-world setting. Eur J Vasc Endovasc Surg.2025; doi: 10.1016/j.ejvs.2025.03.010
2 Tosaka A, Soga Y, Iida O, et al. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012;59:16-23.
