Cook Medical has announced that its Zilver PTX drug-eluting stent (DES) has lower rates of in-stent occlusions among patients with restenosis at three years than the Eluvia DES (Boston Scientific), according to real-world data from the REALDES study. The company notes that the data, published by Tsuyoshi Shibata (Sapporo Medical University Hospital, Sapporo, Japan) et al in the European Journal of Vascular and Endovascular Surgery (EJVES), are the first to compare Zilver PTX and Eluvia in real-world practice at three years.
“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 peripheral arterial disease and venous specialty. “We are grateful to the physicians and hospitals that participated in this study.”
REALDES is an investigator-initiated multicentre, prospective, observational study designed to compare the Zilver PTX DES and 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% vs. Eluvia, 65.2%; p=0.74) or freedom from clinically driven target lesion revascularisation (CD-TLR; 79.4% vs. 76.3%; p=0.27), despite the Zilver PTX arm having longer lesions (185.7±92mm vs. 160±99mm; p<0.005).
- In patients with restenosis at three years, there was a significantly higher rate of in-stent occlusions (Tosaka class III) for those treated with Eluvia (57.7%) compared to Zilver PTX (29.2%; p=0.041).
“These findings contribute valuable insights into optimising treatment outcomes and guiding future stent selection,” said Shibata.
