Onyx is a zotarolimus-eluting stent (ZES), designed with thin struts and a platinum core that enhances its radiological visibility. This can be beneficial in complex situations with limited visibility, such as in patients who are obese or present severe calcification, two particularly frequent characteristics in diabetic or elderly patients.
The BIONYX study was a randomized trial that compared the Onyx ZES with Orsiro, a sirolimus-eluting stent (SES) with ultrathin biodegradable struts. At 1 year, Onyx ZES was not inferior to Orsiro SES in terms of device safety and efficacy, and both stents showed good clinical outcomes at three years.
In this study, researchers analyzed and reported the five-year results of Onyx ZES versus Orsiro SES. It included a pre-specified analysis in diabetic and elderly patients.
Patients were randomized 1:1 and stratified by sex and diabetes status. Safety and efficacy were evaluated through the incidence of target-vessel failure (TVF), which is a composite of cardiovascular death, myocardial infarction, or repeat target-vessel revascularization. Secondary endpoints included target-lesion failure (TLF), major adverse cardiac events (MACE), and stent thrombosis.
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The analysis included a total of 2488 patients with 3239 treated lesions. Of them 23.9% were women, 20.5% had diabetes, and in 70.9% of cases the cause for the percutaneous coronary intervention was acute coronary syndrome. The follow-up rate at 5 years was 97%.
There were no significant differences between groups regarding the primary endpoint of TVF (hazard ratio [HR]: 0.94; 95% confidence interval [CI]: 0.75–1.17; plog-rank = 0.55) or its individual components, such as TLF (HR: 0.87; 95% CI: 0.69–1.11; plog-rank = 0.30), MACE (HR: 0.90; 95% CI: 0.75–1.08; plog-rank = 0.26), or definite stent thrombosis (HR: 0.79; 95% CI: 0.37–1.69; plog-rank = 0.54). Target lesion revascularization (TLR) was lower in the Onyx ZES group during the last two years of follow-up (1.1% vs. 2.4%, HR: 0.47; 95% CI: 0.24–0.93; plog-rank = 0.026).
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In the diabetes subgroup, there were no significant differences between the stents as regards the assessed outcomes. Patients older than 75 years had lower rates of TVF (13.8% vs. 21.9%, HR: 0.60; 95% CI: 0.39–0.93; plog-rank = 0.023).
Conclusions
In the five-year follow-up of the BIONYX study, comparing the Onyx zotarolimus-eluting stent with the Orsiro sirolimus-eluting stent, there were no differences in the primary endpoint or its individual components. Additionally, both stents had a low rate of definite thrombosis. There were no significant differences in the diabetes subgroup. A trend towards fewer events was identified only in patients older than 75 years.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Final 5‐year report of BIONYX comparing the thin‐composite wire‐strut zotarolimus‐eluting stent versus ultrathin‐strut sirolimus‐eluting stent.
Reference: van Vliet D, Ploumen EH, Pinxterhuis TH, Buiten RA, Aminian A, Schotborgh CE, Danse PW, Roguin A, Anthonio RL, Benit E, Zocca P, Doggen CJM, von Birgelen C. Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent. Catheter Cardiovasc Interv. 2024 May 7. doi: 10.1002/ccd.31067. Epub ahead of print. PMID: 38713843.
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