Acute myocardial infarction treated with novel Resolute Onyx and Orsiro stents in the randomized BIONYX trial

Catheter Cardiovasc Interv. 2021 Aug 1;98(2):E188-E196. doi: 10.1002/ccd.29594. Epub 2021 Mar 10.

Abstract

Objectives: To compare 2-year outcome following treatment with drug-eluting stents (DES) for acute myocardial infarction (MI) versus non-MI clinical syndromes. In acute MI patients, a stent-level comparison was performed, comparing Resolute Onyx versus Orsiro stents.

Background: In patients presenting with acute MI, higher adverse event rates have been reported. So far, no clinical results >1 year have been published of acute MI patients treated with Resolute Onyx.

Methods: This post-hoc analysis of the randomized BIONYX trial(NCT02508714) assessed the main outcome target vessel failure (TVF: cardiac death, target vessel MI, or target vessel revascularization) with Kaplan-Meier methods.

Results: Of all 2,488 trial participants, acute MI patients (n = 1,275[51.2%]) were significantly younger and had less comorbidities than non-MI patients (n = 1,213[48.8%]). TVF rates were lower in acute MI patients (77/1,275[6.1%] vs. 103/1,213[8.6%], HR:0.70, 95%-CI 0.52-0.94; plog-rank = 0.02), mainly driven by target vessel revascularization (4.1 vs. 6.1%, plog-rank = 0.03). Multivariate analysis showed no independent association of clinical syndrome with TVF (adjusted-HR: 0.81, 95%-CI 0.60-1.10; p = .17). In MI patients treated with Resolute Onyx (n = 626) versus Orsiro (n = 649), there was no difference in TVF (6.2 vs. 6.1%; plog-rank = 0.97) and its components. There was only 1(0.2%) definite-or-probable stent thrombosis in RO-ZES and 8(1.2%) in O-SES (p = .053).

Conclusions: Two years after treatment with thin-strut DES in this randomized trial, patients treated for acute MI had lower adverse event rates than non-MI patients. Yet, these findings were mainly attributable to between-group differences in patient and lesion characteristics. In patients who underwent PCI for acute MI, both Resolute Onyx and Orsiro showed favorable and similar 2-year outcomes.

Keywords: clinical trials; drug-eluting stent; myocardial infarction; percutaneous coronary intervention.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Drug-Eluting Stents*
  • Everolimus
  • Humans
  • Myocardial Infarction*
  • Percutaneous Coronary Intervention* / adverse effects
  • Prosthesis Design
  • Sirolimus
  • Stents
  • Treatment Outcome

Substances

  • Everolimus
  • Sirolimus

Grants and funding