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dc.contributor.authorByrne, RAen_US
dc.contributor.authorStefanini, GGen_US
dc.contributor.authorCapodanno, Den_US
dc.contributor.authorOnuma, Yen_US
dc.contributor.authorBaumbach, Aen_US
dc.contributor.authorEscaned, Jen_US
dc.contributor.authorHaude, Men_US
dc.contributor.authorJames, Sen_US
dc.contributor.authorJoner, Men_US
dc.contributor.authorJüni, Pen_US
dc.contributor.authorKastrati, Aen_US
dc.contributor.authorOktay, Sen_US
dc.contributor.authorWijns, Wen_US
dc.contributor.authorSerruys, PWen_US
dc.contributor.authorWindecker, Sen_US
dc.description.abstractA 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.en_US
dc.format.extent1591 - 1601en_US
dc.relation.ispartofEur Heart Jen_US
dc.subjectAbsorbable Implantsen_US
dc.subjectPercutaneous Coronary Interventionen_US
dc.subjectTissue Scaffoldsen_US
dc.titleReport of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary.en_US
pubs.notesNot knownen_US

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