Rosaly A Buiten1, Eline H Ploumen1, Paolo Zocca2, Carine J M Doggen3, Gillian A J Jessurun4, Carl E Schotborgh5, Ariel Roguin6, Peter W Danse7, Edouard Benit8, Adel Aminian9, K Gert van Houwelingen2, Alexander R Schramm4, Martin G Stoel2, Samer Somi5, Marc Hartmann2, Gerard C M Linssen10, Clemens von Birgelen11. 1. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. 2. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands. 3. Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. 4. Department of Cardiology, Treant Zorggroep, Scheper Hospital, Emmen, the Netherlands. 5. Department of Cardiology, Haga Hospital, the Hague, the Netherlands. 6. Department of Cardiology, Rambam Medical Center, Haifa, Israel. 7. Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands. 8. Department of Cardiology, Jessa Hospital, Hasselt, Belgium. 9. Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium. 10. Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands. 11. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.
Abstract
OBJECTIVES: The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis. BACKGROUND: The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates. METHODS:A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods. RESULTS: Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]). CONCLUSIONS: At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.
RCT Entities:
OBJECTIVES: The aim of this study was to assess 2-year safety and efficacy of the current-generation thin composite-wire-strut durable-polymer Resolute Onyx zotarolimus-eluting stent (ZES), compared with the ultrathin-strut biodegradable-polymer Orsiro sirolimus-eluting stent (SES) in all-comers and a pre-specified small-vessel subgroup analysis. BACKGROUND: The Resolute Onyx ZES is widely used in clinical practice, but no follow-up data beyond 1 year have been published. The randomized BIONYX (Bioresorbable Polymer-Coated Orsiro Versus Durable Polymer-Coated Resolute Onyx Stents) trial (NCT02508714) established the noninferiority of ZES versus SES regarding target vessel failure (TVF) rates. METHODS: A total of 2,488 all-comer patients were treated at 7 coronary intervention centers in Belgium, Israel, and the Netherlands. The main endpoint, TVF, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (clinically indicated target vessel revascularization). Two-year follow-up data were analyzed using Kaplan-Meier methods. RESULTS: Two-year follow-up data were available for 2,460 of 2,488 patients (98.9%). TVF occurred in 93 of 1,243 patients (7.6%) assigned to ZES versus 87 of 1,245 patients (7.1%) assigned to SES (log-rank p = 0.66). There was no significant between-stent difference in individual components of this endpoint. The incidence of definite-or-probable stent thrombosis was low for both treatment arms (0.4% vs. 1.1%; log-rank p = 0.057). In patients stented in small vessels, there was no between-stent difference (TVF 8.2% vs. 8.7% [log-rank p = 0.75], target lesion revascularization 4.0% vs. 4.4% [log-rank p = 0.77]). CONCLUSIONS: At 2-year follow-up, the novel thin composite-wire-strut durable-polymer Resolute Onyx ZES showed in all-comers similar safety and efficacy compared with the ultrathin cobalt-chromium-strut biodegradable-polymer Orsiro SES. The analysis of patients who were treated in small vessels also suggested no advantage for either stent.
Authors: Mahesh V Madhavan; James P Howard; Azim Naqvi; Ori Ben-Yehuda; Bjorn Redfors; Megha Prasad; Bahira Shahim; Martin B Leon; Sripal Bangalore; Gregg W Stone; Yousif Ahmad Journal: Eur Heart J Date: 2021-07-15 Impact factor: 29.983
Authors: Ian B A Menown; Mamas A Mamas; James M Cotton; David Hildick-Smith; Franz R Eberli; Gregor Leibundgut; Damras Tresukosol; Carlos Macaya; Samuel Copt; Sara Sadozai Slama; Keith G Oldroyd Journal: J Interv Cardiol Date: 2021-04-01 Impact factor: 2.279