Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary

EuroIntervention. 2018 Jan 20;13(13):1574-1586. doi: 10.4244/EIJ20170912-01.

Abstract

A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

Publication types

  • Practice Guideline
  • Review

MeSH terms

  • Absorbable Implants* / standards
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Clinical Decision-Making
  • Coated Materials, Biocompatible* / standards
  • Consensus
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / surgery*
  • Humans
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / standards
  • Platelet Aggregation Inhibitors / administration & dosage
  • Prosthesis Design
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Platelet Aggregation Inhibitors