Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up

Daphne van Vliet; Eline H Ploumen; Tineke H Pinxterhuis; Carine J M Doggen; Adel Aminian; Carl E Schotborgh; Peter W Danse; Ariel Roguin; Rutger L Anthonio; Edouard Benit; Marlies M Kok; Gerard C M Linssen; Clemens von Birgelen

doi:10.1007/s00392-025-02622-7

Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up

Clin Res Cardiol. 2025 Mar 4. doi: 10.1007/s00392-025-02622-7. Online ahead of print.

Authors

Daphne van Vliet^{1

2}, Eline H Ploumen^{1

2}, Tineke H Pinxterhuis^{1

2}, Carine J M Doggen², Adel Aminian³, Carl E Schotborgh⁴, Peter W Danse⁵, Ariel Roguin⁶, Rutger L Anthonio⁷, Edouard Benit⁸, Marlies M Kok¹, Gerard C M Linssen⁹, Clemens von Birgelen^{10

11}

Affiliations

¹ Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, (A-25), Koningsplein 1, 7512 KZ, Enschede, The Netherlands.
² Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands.
³ Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
⁴ Department of Cardiology, Haga Hospital, The Hague, The Netherlands.
⁵ Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.
⁶ Department of Cardiology, Hillel Yaffe Medical Center Hadera, and B. Rappaport-Faculty of Medicine Israel Institute of Technology, Haifa, Israel.
⁷ Department of Cardiology, Scheper Hospital, Treant Zorggroep, Emmen, The Netherlands.
⁸ Department of Cardiology, Jessa Hospital, Hasselt, Belgium.
⁹ Department of Cardiology, Ziekenhuisgroep Twente, Almelo, Hengelo, The Netherlands.
¹⁰ Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, (A-25), Koningsplein 1, 7512 KZ, Enschede, The Netherlands. c.vonbirgelen@mst.nl.
¹¹ Department of Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands. c.vonbirgelen@mst.nl.

PMID: 40035811
DOI: 10.1007/s00392-025-02622-7

Abstract

Background: Percutaneous coronary intervention (PCI) with new-generation drug-eluting stents is increasingly performed in elderly patients, who generally have more comorbidities and more technically challenging target lesions. Nevertheless, there is a paucity of reported data on the long-term safety and efficacy of PCI with contemporary stents in elderly all-comers.

Methods: This prespecified secondary analysis of a large-scale randomized clinical trial (BIONYX; clinicaltrials.gov:NCT02508714) compared in elderly all-comers (≥ 75 years) the 5-year outcome after PCI with the novel, more radiopaque Onyx zotarolimus-eluting stent (ZES) versus the Orsiro sirolimus-eluting stent (SES). We assessed the main composite endpoint target vessel failure (TVF: cardiac death, target vessel myocardial infarction, or target vessel revascularization) and several secondary endpoints.

Results: Of 2,488 trial participants, 475(19.1%) were elderly (79.5 ± 3.5 years), including 165(34.7%) women. There was a significant between-stent difference in the main endpoint TVF in favor of the Onyx ZES (14.4% vs. 24.2%, HR: 0.60, 95% CI 0.39-0.93, p_log-rank = 0.02). The time-to-event curves displayed between-stent dissimilarities across all components of TVF, yet not statistically significant. Landmark analysis between 1- and 5-year follow-up showed in Onyx ZES-treated patients significantly lower rates of TVF (7.8% vs.8.9%, p = 0.002) and target vessel revascularization (3.0% vs.8.3%, p = 0.029). In addition, the 5-year rates of all-cause mortality and several composite endpoints were lower (p < 0.03) in Onyx ZES-treated patients.

Conclusions: In elderly all-comer patients, those treated with Onyx ZES showed a lower 5-year incidence of the main endpoint of safety and efficacy, as well as several secondary endpoints, than patients treated with Orsiro SES. Further research on this issue is warranted.

Clinical trial registration information: https://clinicaltrials.gov/study/NCT02508714.

Keywords: Coronary artery disease; Drug-eluting stents; Elderly patients; Long-term follow-up; Percutaneous coronary intervention; Randomized controlled trial.

Associated data

ClinicalTrials.gov/NCT02508714