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

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

Daphne van Vliet  1   2 , Eline H Ploumen  1   2 , Tineke H Pinxterhuis  1   2 , Carine J M Doggen  2 , Adel Aminian  3 , Carl E Schotborgh  4 , Peter W Danse  5 , Ariel Roguin  6 , Rutger L Anthonio  7 , Edouard Benit  8 , Marlies M Kok  1 , Gerard C M Linssen  9 , Clemens von Birgelen  10   11
Affiliations

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

Daphne van Vliet et al. Clin Res Cardiol. .

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, plog-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.

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Conflict of interest statement

Declarations. Conflict of interest: CvB reports no personal fees; institutional research grants to the research department of Thoraxcentrum Twente from Biotronik and Medtronic, and –outside the submitted work– from Abbott Vascular and Boston Scientific. All authors declared that they have no conflict of interest. No further acknowledgements are reported. Ethics approval and consent to participate: The BIONYX was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Medical Ethics Committee Twente and the local institutional review boards of all participating centers. Informed consent was obtained from all subjects enrolled in this trial.

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