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 Jul;104(1):1-9. doi: 10.1002/ccd.31067. Epub 2024 May 7.

Abstract

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.

Keywords: coronary artery disease; drug‐eluting stent; long‐term follow‐up; percutaneous coronary intervention; randomized controlled trial.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Cardiac Catheters
  • Cardiovascular Agents* / administration & dosage
  • Cardiovascular Agents* / adverse effects
  • Coronary Artery Disease* / diagnostic imaging
  • Coronary Artery Disease* / mortality
  • Coronary Artery Disease* / therapy
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / instrumentation
  • Percutaneous Coronary Intervention* / mortality
  • Prospective Studies
  • Prosthesis Design*
  • Risk Factors
  • Sirolimus* / administration & dosage
  • Sirolimus* / adverse effects
  • Sirolimus* / analogs & derivatives
  • Time Factors
  • Treatment Outcome

Substances

  • zotarolimus
  • Sirolimus
  • Cardiovascular Agents

Grants and funding