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Background <p>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 <i>long-term</i> safety and efficacy of PCI with contemporary stents in elderly all-comers.</p> Methods <p>This prespecified secondary analysis of a large-scale randomized clinical trial (BIONYX; <i>clinicaltrials.gov:NCT02508714</i>) compared in elderly all-comers (≥ 75&#xa0;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.</p> Results <p>Of 2,488 trial participants, 475(19.1%) were elderly (79.5 ± 3.5&#xa0;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<sub>log-rank</sub> = 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 &lt; 0.03) in Onyx ZES-treated patients.</p> Conclusions <p>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.</p> Clinical trial registration information <p><a href="https://clinicaltrials.gov/study/NCT02508714.">https://clinicaltrials.gov/study/NCT02508714.</a></p> Graphical abstract <p></p>

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

  • 期刊论文

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  • 发表日期：

    2025年3月4日

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  • 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

摘要

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.

Graphical abstract