Long-term outcomes following bioresorbable vascular scaffolds

ABSTRACT

Introduction

The higher scaffold thrombosis rates observed with the first-generation bioresorbable scaffolds (BRSs) compared to conventional drug-eluting stents were likely due in part to bioresorbable polymers having insufficient radial strength, necessitating larger strut profiles. Meta-analysis of the long-term outcomes from the first-generation Absorb bioresorbable vascular scaffold (BVS) showed that this period of excess risk ended at 3 years. Therefore, current attention has been focused on improving early outcomes by increasing the scaffold’s tensile strength and reducing strut thickness.

Areas covered

This review summaries the lessons learned from the first-generation BRS. It updates the long-term clinical outcomes of trials evaluating the ABSORB BVS and metallic alloy based BRS. In addition, it reviews the next-generation BRSs manufactured in Asia.

Expert opinion

Critical areas to improve the performance and safety of biodegradable scaffolds include further development in material science, surface modification, delivery systems, and long-term follow-up studies.

KEYWORDS:

• Drug-eluting stents
• bioresorbable scaffold
• new generation scaffold
• long term outcomes for bioresorbable scaffold

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Article highlights

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

• The new-iteration of the magnesium scaffold (BioMag) demonstrated improved angiographic performance in comparison with the previous generation magnesium scaffold. A randomised trial comparing this new magnesium scaffold and metallic drug-eluting stent is in planning.

• The iron-based BRS showed stable angiographic late loss up to 3 years with acceptable event rates.

• The newer generation of polymeric BRS (Esprit scaffold) is tested in the field of peripheral artery disease and demonstrated favourable outcomes in comparison with balloon angioplasty in patients with stenosis in the below-the-knee arteries.

Declaration of interest

PW Serruys has received institutional grants from SMT Sahajanand Medical technological, Sinomedical Sciences Technology, Novartis, Xeltis, Phillips, and Meril life outside the submitted work. K Miyashita has received research grants from OrbusNeich Medical K.K. 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.