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Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary
Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany.;DZHK German Ctr Cardiovasc Res, Partner Site Munich Heart Alliance, Munich, Germany..
Humanitas Res Hosp, Cardio Ctr, Div Cardiol, Milan, Italy..
Univ Catania, Ferrarotto Hosp, Cardiothorac Vasc Dept, Catania, Italy..
Erasmus MC, Dept Intervent Cardiol, Rotterdam, Netherlands..
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2018 (English)In: EuroIntervention, ISSN 1774-024X, E-ISSN 1969-6213, Vol. 13, no 13, p. 1574-1586Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
EUROPA EDITION , 2018. Vol. 13, no 13, p. 1574-1586
Keywords [en]
bioresorbable scaffold, clinical trials, expert review, regulatory approval
National Category
Cardiac and Cardiovascular Systems
Identifiers
URN: urn:nbn:se:uu:diva-347259DOI: 10.4244/EIJ20170912-01ISI: 000424327300015PubMedID: 28948934OAI: oai:DiVA.org:uu-347259DiVA, id: diva2:1194921
Note

The article has been co-published with permission in the European Heart Journal [DOI: 10.1093/eurheartj/ehx488] and EuroIntervention [DOI: 10.4244/EIJ20170912-01]. All rights reserved in respect of European Heart Journal, © The Author 2017, and in respect of EuroIntervention © The Author 2017. The articles are identical except for minor stylistic and spelling differences in keeping with each journal s style. Either citation can be used when citing this article.

Available from: 2018-04-04 Created: 2018-04-04 Last updated: 2018-04-04Bibliographically approved

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