INTRODUCTION: The concept of bioresorbable scaffolds (BRS) born with the aim to reduce the rate of late and very late cardiac events related to drug-eluting stents. However, first-generation BRS failed to prove their short-term safety and efficacy. Based on data derived from early investigations, new-generation BRS have been developed and tested in preliminary studies. The present review's focus is to summarize the mechanical characteristics of these new scaffolds and the clinical evidence of their safety and efficacy. EVIDENCE ACQUISITION: This systematic review was performed following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). PUBMED, Google Scholar, and Biomed central databases were analyzed. Only papers published in English and in peer-reviewed journals were selected to summarize current evidence about new generation BRS, with CE mark approval. Overall, 23 studies were included. EVIDENCE SYNTHESIS: Data obtained from selected studies assessing the safety and efficacy of new generation BRS are encouraging. This is thanks to the progressive development of scaffolds with a different backbone structure and struts thickness that guarantee higher radial strength, flexibility, and resistance to fracture. These characteristics led to low rates of major adverse cardiac events and device-oriented composite endpoint at follow-up. CONCLUSIONS: New-generation BRS have a good safety profile in stable patients with simple lesions, supported by a meticulous implantation technique. The first studies were performed on a small population with short-term follow-up, therefore new randomized clinical trials and registries are needed to expand the preliminary findings.
INTRODUCTION: The concept of bioresorbable scaffolds (BRS) born with the aim to reduce the rate of late and very late cardiac events related to drug-eluting stents. However, first-generation BRS failed to prove their short-term safety and efficacy. Based on data derived from early investigations, new-generation BRS have been developed and tested in preliminary studies. The present review's focus is to summarize the mechanical characteristics of these new scaffolds and the clinical evidence of their safety and efficacy. EVIDENCE ACQUISITION: This systematic review was performed following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). PUBMED, Google Scholar, and Biomed central databases were analyzed. Only papers published in English and in peer-reviewed journals were selected to summarize current evidence about new generation BRS, with CE mark approval. Overall, 23 studies were included. EVIDENCE SYNTHESIS: Data obtained from selected studies assessing the safety and efficacy of new generation BRS are encouraging. This is thanks to the progressive development of scaffolds with a different backbone structure and struts thickness that guarantee higher radial strength, flexibility, and resistance to fracture. These characteristics led to low rates of major adverse cardiac events and device-oriented composite endpoint at follow-up. CONCLUSIONS: New-generation BRS have a good safety profile in stable patients with simple lesions, supported by a meticulous implantation technique. The first studies were performed on a small population with short-term follow-up, therefore new randomized clinical trials and registries are needed to expand the preliminary findings.
Authors: Matthias Bossard; Mehdi Madanchi; Dardan Avdijaj; Adrian Attinger-Toller; Giacomo Maria Cioffi; Thomas Seiler; Gregorio Tersalvi; Richard Kobza; Guido Schüpfer; Florim Cuculi Journal: Front Cardiovasc Med Date: 2022-04-14