Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Aug 1;98(2):E188-E196.
doi: 10.1002/ccd.29594. Epub 2021 Mar 10.

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

Eline H Ploumen  1   2 , Rosaly A Buiten  1   2 , Paolo Zocca  1 , Carine J M Doggen  2 , Gillian A J Jessurun  3 , Carl E Schotborgh  4 , Ariel Roguin  5 , Peter W Danse  6 , Edouard Benit  7 , Adel Aminian  8 , Rutger L Anthonio  3 , Samer Somi  4 , Gerard C M Linssen  9 , Marc Hartmann  1 , Marlies M Kok  1 , Clemens von Birgelen  1   2
Affiliations

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

Eline H Ploumen et al. Catheter Cardiovasc Interv. .

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.

PubMed Disclaimer

Conflict of interest statement

CvB reports that Thoraxcentrum Twente received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. The other authors have no conflicts of interest to declare.

Figures

FIGURE 1
FIGURE 1
Study flowchart. Abbreviations: MI, myocardial infarction; NSTEMI, non‐ST‐segment elevation myocardial infarction; O‐SES, Orsiro sirolimus‐eluting stent; PCI, percutaneous coronary intervention; RO‐ZES, Resolute Onyx zotarolimus‐eluting stent; STEMI, ST‐segment elevation myocardial infarction
FIGURE 2
FIGURE 2
Kaplan–Meier event curves of Target Vessel Failure and components at 2‐year follow‐up in acute MI patients and non‐MI patients. Abbreviations: CI, confidence interval; HR, hazard ratio; MI, myocardial infarction
FIGURE 3
FIGURE 3
Kaplan–Meier event curves of Target Vessel Failure and components at 2‐year follow‐up in acute MI patients treated with Resolute Onyx versus Orsiro. Abbreviations: CI, confidence interval; HR, hazard ratio; MI, myocardial infarction; O‐SES, Orsiro sirolimus‐eluting stent; RO‐ZES, Resolute Onyx zotarolimus‐eluting stent
See this image and copyright information in PMC

References

    1. Thim T, Maeng M, Kaltoft A, et al. Zotarolimus‐eluting vs. Sirolimus‐eluting coronary stents in patients with and without acute coronary syndromes: a SORT OUT III substudy. Eur J Clin Invest. 2012;42:1047‐1054. - PubMed
    1. Antonsen L, Thayssen P, Hansen HS, et al. Outcomes after revascularization with everolimus‐ and sirolimus‐eluting stents in patients with acute coronary syndromes and stable angina pectoris: a substudy of the SORT OUT IV trial. EuroIntervention. 2014;10:212‐223. - PubMed
    1. Yamaji K, Natsuaki M, Morimoto T, et al. Long‐term outcomes after coronary stent implantation in patients presenting with versus without acute myocardial infarction (an observation from coronary revascularization demonstrating outcome study‐Kyoto registry Cohort‐2). Am J Cardiol. 2015;116:15‐23. - PubMed
    1. Daemen J, Wenaweser P, Tsuchida K, et al. Early and late coronary stent thrombosis of sirolimus‐eluting and paclitaxel‐eluting stents in routine clinical practice: data from a large two‐institutional cohort study. Lancet. 2007;369:667‐678. - PubMed
    1. Nakazawa G, Finn AV, Joner M, et al. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug‐eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008;118:1138‐1145. - PubMed

Publication types

Grants and funding