A randomized global, prospective, multi-center, single-blind trial comparing the Eluvia paclitaxel-eluting stent (Boston Scientific) to Zilver PTX paclitaxel-eluting stent (Cook Medical) has shown that the Eluvia stent outperformed Zilver in terms of efficacy, which was defined as primary patency at 12 months. These findings, published in The Lancet, were presented by Dr. William Gray at the annual TCT 2018 conference held in San Diego today.
The clinical benefit of stenting with self-expanding nitinol stents for the treatment of superficial femoral artery obstructions has previously been established in multiple clinical trials. New-generation drug-eluting stents continue to improve outcomes in patients suffering from femoropoliteal stenosis. In the IMPERIAL trial led by Dr. William Gray, MD (Lankenau Heart Institute, Wynnewood, PA), 465 patients suffering from femoropoliteal stenosis, described as native SFA or proximal popliteal artery lesions with stenosis of at least 70% by visual angiographic assessment, were randomized in a 2:1 ratio to receive either the polymer coated Eluvia or Zilver PTX. A Kaplan-Meier analysis for the length of time after randomization until the occurrence of the primary efficacy endpoint revealed that the patency assessed by duplex ultrasound was 88.5 % for Eluvia, and 79.5 % for Zilver PTX (p= 0.0144), demonstrating clear superiority of the Eluvia drug-eluting stent (DES).
“Clinical outcome rates were similar between groups, but with half the revascularisation rate for Eluvia. Based on these results, the use of a polymer-coated paclitaxel-eluting stent in patients who require superficial femoral artery or popliteal intervention is a reasonable approach to maximize intermediate-term patency and to maintain hemodynamic and clinical improvement without repeat re-intervention.”- Dr. Stefan Müller-Hülsbeck, M.D.
Interestingly, the sustained-release Biostable Fluorinated Polymer Matrix (PROMUS) coated Eluvia DES also proved to be non-inferior to Zilver PTX in terms of safety. The primary safety endpoint was major adverse events, MAE-all-cause death through 1 month and target limb major amputation and target lesion revascularization (TLR) through 1 year, and Eluvia was shown to be non-inferior to Zilver PTX (4.9% vs 9.0%). The lower rates of TLR (4.5% vs 9.0%; p = 0.0672) and stent thrombosis (1.7% vs 4.0%; p = 0.1956) in the Eluvia arm (~50% lower rates for Eluvia) revealed a marked trend toward lower clinically-driven TLR and stent thrombosis rates for Eluvia vs Zilver PTX. This was accompanied by half the revascularization rate for Eluvia. Both stents improved symptomatic, functional, and hemodynamic outcomes through 1 year. In addition, there was a significant improvement from baseline in both groups in terms of walking impairment and six patients treated with Eluvia (2.1%) had positive remodeling in the primary lesions.
The investigators concluded, “Based on these results, the use of a polymer-coated paclitaxel-eluting stent in patients who require superficial femoral artery or popliteal intervention is a reasonable approach to maximize intermediate-term patency and to maintain hemodynamic and clinical improvement without repeat re-intervention.”
“The investigators and I are proud to present these results and we believe that rigorous trials such as the IMPERIAL are truly advanced in the field, and we hope to answer some of the questions that have here before been eluding us. We think this will advance the overall patient care and give operators more information to make better decisions for the patients.”-Dr. William Gray, MD (Principal Investigator, IMPERIAL Trial)