• Liefke C van der Heijden, Marlies M Kok, Paolo Zocca, Jessurun Gillian A J GAJ Treant Zorggroep, Scheper Hospital, Department of Cardiology, Emmen, the Netherlands., Carl E Schotborgh, Ariel Roguin, Edouard Benit, Adel Aminian, Peter W Danse, Marije M Löwik, Linssen Gerard C M GCM Ziekenhuisgroep Twente, Department of Cardiology, Almelo and Hengelo, the Netherlands., Job van der Palen, Doggen Carine J M CJM Department Health Technology and Services Research, MIRA-Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede,, and Clemens von Birgelen.
• Thoraxcentrum Twente, Department of Cardiology, MST, Enschede, the Netherlands.
• Am. Heart J. 2018 Apr 1; 198: 25-32.

AimThe aim was to compare in a noninferiority trial the efficacy and safety of 2 contemporary drug-eluting stents (DESs): a novel, durable polymer-coated stent versus an established bioabsorbable polymer-coated stent.Methods And ResultsThe BIONYX trial (ClinicalTrials.gov-no.NCT02508714) is an investigator-initiated, prospective, randomized, patient- and assessor-blinded, international, multicenter study in all-comer patients with all types of clinical syndromes and lesions who require percutaneous coronary interventions with DES. Patients at 7 study sites in the Netherlands, Belgium, and Israel were randomly assigned (1:1, stratified for gender and diabetes mellitus) to treatment with the novel, zotarolimus-eluting, durable polymer-coated Resolute Onyx stent that has a radiopaque, thin-strut, CoreWire stent platform versus the sirolimus-eluting, bioresorbable polymer-coated Orsiro stent (reference device) that has a very thin-strut, cobalt-chromium stent backbone. The primary end point is the 1-year incidence of the composite clinical end point target vessel failure consisting of cardiac death, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization. A power calculation, assuming a target vessel failure rate of 6.0% (noninferiority margin 2.5%), revealed that 2,470 study patients would give the study 80% power (α level 5%), allowing for up to 3% loss to follow-up. The first patient was enrolled on October 7, 2015; on December 23, 2016, the last patient entered the study.ConclusionsBIONYX is a large-scale, prospective, randomized, international, multicenter trial comparing a novel DES with durable coating versus a reference DES with biodegradable coating in all-comers. The study is the first randomized assessment of the Resolute Onyx stent, which is an often-used DES outside the United States.Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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