title: Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.
abstract: The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.affiliation: Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Bristol Heart Institute, Bristol, UK.
authors.forename: Andreas
authors.initials: A
authors.lastname: Baumbach
authors.affiliation: Interventional Cardiology, Hospital San Carlos, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Escaned
authors.affiliation: Interventional Cardiology, Clinique Pasteur, Toulouse, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.affiliation: Clinical Research Center, Uppsala University, Uppsala, Sweden.
authors.forename: Stefan
authors.initials: S
authors.lastname: James
authors.affiliation: CVPath Institute, Inc., Gaithersburg, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Joner
authors.affiliation: Cardio Med Device Consultants, Baltimore, USA.
authors.forename: Semih
authors.initials: S
authors.lastname: Oktay
authors.affiliation: Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: AHEPA University Hospital, Thessaloniki, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Sianos
authors.affiliation: Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.
authors.forename: Giulio G
authors.initials: GG
authors.lastname: Stefanini
authors.affiliation: Cardiovascular Center O.L.V.Z., Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland stephan.windecker@insel.ch.
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
mesh_terms: D020341:Absorbable Implants; D057791:Cardiac Imaging Techniques; D002309:Cardiology; D057189:Checklist; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005060:Europe; D006801:Humans; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation; D012955:Societies, Medical; D014481:United States
keywords: Bioresorbable stents; Coronary artery disease; Coronary stents; Drug-eluting stents; Percutaneous coronary interventions