1. Evaluation and use of coronary bioresorbable scaffolds:
Report of an ESC/EAPCI Task Force
Robert A. Byrne, MB, BCh, PhD, FESC
Deutsches Herzzentrum München, Munich, GERMANY
October 18, 2017

2. Disclosure
Dr. Byrne received lecture fees from B. Braun Melsungen AG, Biotronik and Boston Scientific and research grants to the institution from Boston Scientific and Heartflow

3. ESC-EAPCI Stent Task Force ESC-EAPCI Scaffold Task Force
Agenda
Evaluation of Coronary Stents and Bioresorbable Scaffolds
Introduction
ESC-EAPCI Stent Task Force
ESC-EAPCI Scaffold Task Force
Lessons learned so far

4. ESC-EAPCI Stent Task Force ESC-EAPCI Scaffold Task Force
Agenda
Evaluation of Coronary Stents and Bioresorbable Scaffolds
Introduction
ESC-EAPCI Stent Task Force
ESC-EAPCI Scaffold Task Force
Lessons learned so far

5. Regulatory Processes: EU
Byrne et al., ESC-EAPCI Stent Task Force | Eur Heart J 2015

6. EC Guidance Documents
The only medical device-specific directive in Europe

7. Problems with the current EU system
Need for a more systematic and thorough evaluation of medical devices before CE-approval
Poor transparency in relation to the basis on which Notified Bodies evaluate and recommend approval of medical devices
Potential disconnect between the two agencies involved in regulation – Competent Authorities and Notified Body
Uncertain requirements for post-market surveillance

8. ESC-EAPCI Stent Task Force ESC-EAPCI Scaffold Task Force
Agenda
Evaluation of Coronary Stents and Bioresorbable Scaffolds
Introduction
ESC-EAPCI Stent Task Force
ESC-EAPCI Scaffold Task Force
Lessons learned so far

9. Systematic review of 158 RCTs
Systematic review of 158 RCTs | Byrne et al., ESC-EAPCI Stent Task Force | Eur Heart J 2015

10. ESC-EAPCI Task Force
ESC-EAPCI Stent Task Force | Eur Heart J 2015

11. ESC-EAPCI Task Force on Stents
ESC TF formation
2013
TF report submitted to EC
2014
Executive summary published EHJ
2015
Dialogue with CIE and JRC
2016
Second report on BRS
2017

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14. ESC-EAPCI Task Force on Stents
ESC TF formation
2013
TF report submitted to EC
2014
Executive summary published EHJ
2015
Dialogue with CIE and JRC
2016
Second report on BRS
2017

15. Work of the Task Force (2)
ESC-EAPCI Task Force on Evaluation of Scaffolds
As basis for its report, the Task Force:
Reviewed rationale and unmet need for BRS
Established a comprehensive list of all BRS with CE mark or in clinical testing
Undertook a systematic review of the literature of all published RCTs evaluating BRS up to 10/2016
Invited PIs of ongoing RCTs to share data with NDA
Provided proposals for evaluation and approval of BRS

16. ESC-EAPCI Task Force on BRS: Report
Target lesion failure
Scaffold thrombosis (def/prob)
Byrne et al., ESC-EAPCI Task Force on BRS | Eur Heart J & EuroIntervention 2017 online; Cassese et al. | EuroIntervention 2017 JAA online

17. Clinical Evaluation Plan for Scaffolds
Byrne et al., ESC-EAPCI Task Force on BRS | Eur Heart J & EuroIntervention 2017 online

18. Recommendations for Clinical Use of BRS1.
Until concerns re. late performance can be assuaged, current generation polymeric BRS should not be preferred to DES in routine practice
Patients already treated with polymeric BRS should be considered for prolonged DAPT (out to the time of reabsorption?)
There is insufficient data to make any recommendations on Mg-alloy BRS at present and further study is required 2. 3.
Byrne et al., ESC-EAPCI Task Force on BRS | Eur Heart J & EuroIntervention 2017 online

19. ESC-EAPCI Stent Task Force ESC-EAPCI Scaffold Task Force
Agenda
Evaluation of Coronary Stents and Bioresorbable Scaffolds
Introduction
ESC-EAPCI Stent Task Force
ESC-EAPCI Scaffold Task Force
Lessons learned so far

20. Lessons learned so far
Provision of this type of expert advice on medical device to EC is feasible but time intensive and requires support
Interaction with regulators facilitated by ESC was valuable and many of TF recommendation were incorporated into draft guidance documents
Work of TF on coronary stents/scaffolds might serve as a pilot project for future endeavours

21. Further reading… Byrne, R.A., Windecker, S. | EuroIntervention 2017
Byrne et al., ESC-EAPCI Task Force on BRS | Eur Heart J & EuroIntervention 2017 online; Cassese et al. | EuroIntervention 2017 JAA online

22. Thank you for your attention!
Robert A. Byrne MB BCh PhD FESC