Zilver PTX peripheral paclitaxel-eluting stent: a technology evaluation

ABSTRACT

Introduction

The Zilver PTX stent was the first self-expanding drug-coated stent approved by the United States Food and Drug Administration (US FDA) for use in the superficial femoral artery (SFA) above the knee. The main objective of this article is to review the design, safety, and efficacy of the Zilver PTX stent which was engineered to outperform bare metal stents (BMS) in this challenging environment.

Areas covered

An evaluation of the Zilver PTX peripheral paclitaxel-coated stent design and a review of the current preclinical and clinical evidence regarding the use of this stent.

Expert opinion

Stent implantation for the treatment of peripheral arterial disease (PAD) in the SFA was initially seen as a salvage option; however, stenting is now routinely offered as initial therapy for patients suffering from claudication and critical limb ischemia. The Zilver PTX stent has established efficacy and safety profiles for paclitaxel in the SFA; however, the development of biocompatible polymers capable of extending the elution time of anti-proliferative agents may lead to more effective stent platforms.

KEYWORDS:

• Drug-eluting stent
• endovascular intervention
• paclitaxel
• peripheral artery disease
• superficial femoral artery

Article highlights

• Restenosis of stented lesions in the SFA occurs predictably at 10-12 months necessitating prolonged elution times of antiproliferative agents.

• Polymers were designed to prolong elution times; however, questions regarding the biocompatibility of first-generation polymers limited their use.

• The non-polymer stent platform of the Zilver PTX stent was initially seen as a protective feature; however, newer polymers with established safety profiles have been developed that can prolong elution times to overlap with the natural history of restenosis in the SFA.

• Current clinical data shows that the Zilver PTX stent is superior to PTA and BMS; however, stents utilizing biocompatible polymers have been developed to compete with the Zilver PTX stent.

• Post-market surveillance of the paclitaxel coated Zilver PTX stent has shown no increase in morbidity and mortality as was described recently in a severely limited meta-analysis.

Declaration of interest

W Gray serves as a consultant for Boston Scientific, Cook Medical, Medtronic, Surmodics, and Philips. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.