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

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

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

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

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

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

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

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

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

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

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

EU WGi Clintcal rnv.estcgati:on mu:I db (t) ESC European Society of Cardiology Report of a ESC-EAPCI task force on the evaluation of coronary stents in Eur ope: EU WGi Clintcal rnv.estcgati:on mu:I db .· . D - - - - E.vatuation, j(: !El, ,rntti Noviem b er 2015 nm --i -- •«h Htrn nllUJll Umh U l li'ER rTIU •ER r e, .,. t 1.:1 1 I •

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

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

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

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

Recommendations for Clinical Use of BRS 1. 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

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

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

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

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