Drug-eluting bioresorbable scaffolds in cardiovascular disease, peripheral artery and gastrointestinal fields: a clinical update

ABSTRACT

Introduction

The technology of bioresorbable scaffold (BRS) spread out after the success of the first-in-man trials of the Absorb. However, the randomized trials demonstrated that major adverse cardiac events and scaffold thrombosis rates of the first-generation Absorb were higher than those of the metallic everolimus-eluting stent. To overcome the shortcoming of the firstly commercialized Absorb, novel technologies have been developed.

Areas covered

In this review, we overviewed the field of BRS in the treatment of coronary, peripheral artery and gastrointestinal fields. To date, 10 BRS devices developed by 6 manufacturers have acquired the CE mark in coronary artery disease. Currently 8 BRS are in clinical trial phase, whereas 7 BRS are in preclinical assessment phase. Most new-generation devices have a strut thickness of less than 100 μm. However, late favorable outcome might be achieved not only by device refinement but also by a proper technique of implantation using intra vascular imaging guidance, as well as with a careful patient and lesion selection.

Expert opinion

New-generation BRS will be soon tested in the clinical arena to demonstrate improved acute and long-term of safety and efficacy.

KEYWORDS:

• Bioresorbable scaffold
• CE mark
• absorb
• new generation scaffold
• scaffold thrombosis

Article highlights

• New-generation BRS for CAD has been developed to overcome the shortcoming of the first-generation Absorb.

• Improvement of new-generation BRS might be achieved not only by device refinement but also by proper technique of implantation under intravascular imaging guidance, as well as careful patient and lesion selection.

• Several kinds of new-generation BRS have been developed and the ongoing trials are currently taking place mainly in Asia.

• New-generation BRS will be soon tested in the clinical arena and attempted to improve the acute and long-term safety and efficacy.

• BRS is expanding its application from coronary artery disease to peripheral artery disease and gastrointestinal field.

This box summarizes key points contained in the article.

Declaration of interest

PW Serruys reports personal fees from Sino Medical Sciences Technology, personal fees from Philips/Volcano, personal fees from Xeltis, outside the submitted work. 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.