TY - JOUR
T1 - Final 5-year report of BIONYX comparing the thin-composite wire-strut zotarolimus-eluting stent versus ultrathin-strut sirolimus-eluting stent
AU - van Vliet, Daphne
AU - Ploumen, Eline H.
AU - Pinxterhuis, Tineke H.
AU - Buiten, Rosaly A.
AU - Aminian, Adel
AU - Schotborgh, Carl E.
AU - Danse, Peter W.
AU - Roguin, Ariel
AU - Anthonio, Rutger L.
AU - Benit, Edouard
AU - Zocca, Paolo
AU - Doggen, Carine J.M.
AU - von Birgelen, Clemens
N1 - Publisher Copyright:
© 2024 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
PY - 2024/7/1
Y1 - 2024/7/1
N2 - Background: The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer-coated zotarolimus-eluting stent (ZES) in all-comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable-polymer sirolimus-eluting stent (SES) in all-comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow-up.Aims: We aimed to assess long-term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5-year follow-up. Methods: The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan–Meier methods, applying the log-rank test for between-group comparison.Results: Follow-up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] [0.75–1.17], plog-rank = 0.55). Landmark analysis between 3- and 5-year follow-up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI [0.24–0.93], plog-rank = 0.026). A prespecified subgroup analysis showed no significant between-stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI [0.39–0.93], plog-rank = 0.023).Conclusions: The final 5-year analysis of the randomized BIONYX trial showed favorable and similar long-term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all-comers and patients with diabetes.
AB - Background: The BIONYX randomized trial is the first study to evaluate the Resolute Onyx durable polymer-coated zotarolimus-eluting stent (ZES) in all-comers. Furthermore, it is the first trial to assess safety and efficacy of this stent versus the Orsiro biodegradable-polymer sirolimus-eluting stent (SES) in all-comers, paying particular attention to patients with diabetes. It has previously shown promising results until 3 years of follow-up.Aims: We aimed to assess long-term clinical outcome after percutaneous coronary intervention (PCI) with Onyx ZES versus Orsiro SES at 5-year follow-up. Methods: The main composite endpoint was target vessel failure (TVF): cardiac death, target vessel myocardial infarction, or target vessel revascularization. Time to primary and secondary endpoints was assessed using Kaplan–Meier methods, applying the log-rank test for between-group comparison.Results: Follow-up was available in 2414/2488 (97.0%) patients. After 5 years, TVF showed no significant difference between Onyx ZES and Orsiro SES (12.7% vs. 13.7%, hazard ratio [HR] 0.94, 95% confidence interval [CI] [0.75–1.17], plog-rank = 0.55). Landmark analysis between 3- and 5-year follow-up found a lower target lesion revascularization rate for Onyx ZES (1.1% vs. 2.4%, HR 0.47, 95% CI [0.24–0.93], plog-rank = 0.026). A prespecified subgroup analysis showed no significant between-stent difference in clinical outcome among patients with diabetes. After treatment with Onyx ZES, patients aged ≥75 years had significantly lower rates of TVF (13.8% vs. 21.9%, HR 0.60, 95% CI [0.39–0.93], plog-rank = 0.023).Conclusions: The final 5-year analysis of the randomized BIONYX trial showed favorable and similar long-term outcomes of safety and efficacy for Onyx ZES and Orsiro SES in both all-comers and patients with diabetes.
KW - UT-Hybrid-D
KW - Drug-eluting stent
KW - Long-term follow-up
KW - Percutaneous coronary intervention
KW - Randomized controlled trial
KW - Coronary artery disease
UR - http://www.scopus.com/inward/record.url?scp=85192263170&partnerID=8YFLogxK
U2 - 10.1002/ccd.31067
DO - 10.1002/ccd.31067
M3 - Article
C2 - 38713843
AN - SCOPUS:85192263170
SN - 1522-1946
VL - 104
SP - 1
EP - 9
JO - Catheterization and cardiovascular interventions
JF - Catheterization and cardiovascular interventions
IS - 1
ER -
