Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents (BIONYX): Rationale and design of the randomized TWENTE IV multicenter trial
Liefke van der Heijden;Marlies Kok;Paolo Zocca;Gillian Jessurun;Carl Schotborgh;Ariel Roguin;Edouard Benit;Adel Aminian;Peter Danse;Marije Löwik;Gerard Linssen;Job van der Palen;Carine Doggen;Clemens von Birgelen;
aThoraxcentrum Twente, Department of Cardiology, MST, Enschede, the NetherlandsbTreant Zorggroep, Scheper Hospital, Department of Cardiology, Emmen, the NetherlandscHaga Hospital, Department of Cardiology, The Hague, the NetherlandsdRambam Medical Center, Department of Cardiology, Haifa, IsraeleTechnion, Israel Institute of Technology, Haifa, IsraelfJessa Hospital, Department of Cardiology, Hasselt, BelgiumgCentre Hospitalier Universitaire de Charleroi, Department of Cardiology, Charleroi, BelgiumhRijnstate Hospital Arnhem, Department of Cardiology, Arnhem, the NetherlandsiZiekenhuisgroep Twente, Department of Cardiology, Almelo and Hengelo, the NetherlandsjDepartment of Epidemiology, Medisch Spectrum Twente, Enschede, the NetherlandskDepartment of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, the NetherlandslDepartment Health Technology and Services Research, MIRA–Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands
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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.