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

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^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Article number	e012438
Pages (from-to)	1681-1691
Number of pages	11
Journal	Clinical research in cardiology
Volume	114
Issue number	12
Early online date	4 Mar 2025
DOIs	https://doi.org/10.1007/s00392-025-02622-7
Publication status	Published - Dec 2025

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

UT-Hybrid-D
Drug-eluting stents
Elderly patients
Long-term follow-up
Percutaneous coronary intervention
Randomized controlled trial
Coronary artery disease

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van Vliet, D., Ploumen, E. H., Pinxterhuis, T. H., Doggen, C. J. M., Aminian, A., Schotborgh, C. E., Danse, P. W., Roguin, A., Anthonio, R. L., Benit, E., Kok, M. M., Linssen, G. C. M., & von Birgelen, C. (2025). Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up. Clinical research in cardiology, 114(12), 1681-1691. Article e012438. https://doi.org/10.1007/s00392-025-02622-7

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

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 = "UT-Hybrid-D, Drug-eluting stents, Elderly patients, Long-term follow-up, Percutaneous coronary intervention, Randomized controlled trial, Coronary artery disease",

author = "\{van Vliet\}, Daphne and Ploumen, \{Eline H.\} and Pinxterhuis, \{Tineke H.\} and Doggen, \{Carine J.M.\} and Adel Aminian and Schotborgh, \{Carl E.\} and Danse, \{Peter W.\} and Ariel Roguin and Anthonio, \{Rutger L.\} and Edouard Benit and Kok, \{Marlies M.\} and Linssen, \{Gerard C.M.\} and \{von Birgelen\}, Clemens",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025.",

year = "2025",

month = dec,

doi = "10.1007/s00392-025-02622-7",

language = "English",

volume = "114",

pages = "1681--1691",

journal = "Clinical research in cardiology",

issn = "1861-0684",

publisher = "Springer",

number = "12",

}

van Vliet, D, Ploumen, EH, Pinxterhuis, TH, Doggen, CJM, Aminian, A, Schotborgh, CE, Danse, PW, Roguin, A, Anthonio, RL, Benit, E, Kok, MM, Linssen, GCM & von Birgelen, C 2025, 'Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up', Clinical research in cardiology, vol. 114, no. 12, e012438, pp. 1681-1691. https://doi.org/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. / van Vliet, Daphne; Ploumen, Eline H.; Pinxterhuis, Tineke H. et al.
In: Clinical research in cardiology, Vol. 114, No. 12, e012438, 12.2025, p. 1681-1691.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up

AU - van Vliet, Daphne

AU - Ploumen, Eline H.

AU - Pinxterhuis, Tineke H.

AU - Doggen, Carine J.M.

AU - Aminian, Adel

AU - Schotborgh, Carl E.

AU - Danse, Peter W.

AU - Roguin, Ariel

AU - Anthonio, Rutger L.

AU - Benit, Edouard

AU - Kok, Marlies M.

AU - Linssen, Gerard C.M.

AU - von Birgelen, Clemens

PY - 2025/12

Y1 - 2025/12

N2 - 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.

AB - 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.

KW - UT-Hybrid-D

KW - Drug-eluting stents

KW - Elderly patients

KW - Long-term follow-up

KW - Percutaneous coronary intervention

KW - Randomized controlled trial

KW - Coronary artery disease

UR - https://www.scopus.com/pages/publications/86000311311

U2 - 10.1007/s00392-025-02622-7

DO - 10.1007/s00392-025-02622-7

M3 - Article

C2 - 40035811

AN - SCOPUS:86000311311

SN - 1861-0684

VL - 114

SP - 1681

EP - 1691

JO - Clinical research in cardiology

JF - Clinical research in cardiology

IS - 12

M1 - e012438

ER -

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

Abstract

UN SDGs

Keywords

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