Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary
Methodological detailsexecutive summary
- Executive summary
Recommendations
As issued by the authors
At present bioresorbable scaffolds (BRS) should not be preferred to conventional drug-eluting stents (DES) in clinical practice.
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 RCT with planned long-term follow-up.
Original publication
Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. Eur Heart J. Published 28 August 2017. doi:10.
Summarised from the published abstract; every number is checked against it