Evaluation and use of bioresorbable scaffolds for PCI
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.
Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for PCI: executive summary by R. Byrne, et al.