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Title: | First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial | Authors: | Ploumen, Eline H. Buiten, Rosaly A. Zocca, Paolo Doggen, Carine J. M. Aminian, Adel Schotborgh, Carl E. Jessurun, Gillian A. J. Roguin, Ariel Danse, Peter W. BENIT, Edouard von Birgelen, Clemens |
Issue Date: | 2021 | Publisher: | JAPANESE CIRCULATION SOC | Source: | CIRCULATION JOURNAL, 85 (11) , p. 1983 -1990 | Abstract: | Background: At 1 year, the international randomized BIONYX trial (ClinicalTrials.gov:NCT02508714) established non-inferiority regarding safety and efficacy of the novel Resolute Onyx zotarolimus-eluting stent (RO-ZES) vs. the Orsiro sirolimus-eluting stent (O-SES). Although the RO-ZES is used in daily practice, no clinical results have been published beyond 2 years. Methods and Results: We assessed 3-year clinical outcomes of 2,488 all-comers after percutaneous coronary intervention (PCI) with RO-ZES vs. O-SES. The main endpoint was target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction (MI), or target vessel revascularization. Time-to-endpoints was assessed by Kaplan-Meier methods and between-group comparisons by log-rank tests. Follow-up was available in 2,433/2,488 (97.8%) patients. There was no significant between-stent difference in TVF (RO-ZES 112/1,243 [9.2%] vs. O-SES 109/1,245 [8.9%], hazard ratio [HR]: 1.03, 95% confidence interval [CI] 0.79-1.34; Plog-rank=0.85) and its individual components. The all-cause mortality was significantly lower after PCI with RO-ZES (3.7% vs.5.4%, HR: 0.67, 95% CI 0.46-0.97; Plog-rank=0.034), but cardiac mortality did not differ significantly (1.1% vs.1.9%, HR: 0.56, 95% CI 0.28-1.11; Plog-rank=0.09). Definite-or-probable stent thrombosis rates were low for both groups (0.6% vs.1.2%, HR: 0.46, 95% CI 0.19-1.14; Plog-rank=0.09). Conclusions: This first 3-year randomized assessment of the RO-ZES showed a favorable rate of TVF that matched the outcomes of patients treated with O-SES. We observed a lower rate of all-cause death in the RO-ZES group, but long-term clinical follow-up is of interest. | Notes: | von Birgelen, C (corresponding author), Med Spectrum Twente, Dept Cardiol, Thoraxctr Twente, Koningspl 1, NL-7512 KZ Enschede, Netherlands. c.vonbirgelen@mst.nl |
Keywords: | All-comer trials; Drug-eluting stents; Percutaneous coronary;intervention; Randomized controlled trials | Document URI: | http://hdl.handle.net/1942/36032 | ISSN: | 1346-9843 | e-ISSN: | 1347-4820 | DOI: | 10.1253/circj.CJ-21-0292 | ISI #: | WOS:000711022600010 | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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85_CJ-21-0292.pdf | Published version | 1.16 MB | Adobe PDF | View/Open |
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