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
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Nevertheless, there is a paucity of reported data on the long-term safety and efficacy of PCI with contemporary stents in elderly all-comers.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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<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 < 0.03) in Onyx ZES-treated patients.</p><p><strong>Conclusions: </strong>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><p><strong>Clinical trial registration information: </strong>https://clinicaltrials.gov/study/NCT02508714.</p>","PeriodicalId":10474,"journal":{"name":"Clinical Research in Cardiology","volume":" ","pages":"1681-1691"},"PeriodicalIF":3.7000,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12708834/pdf/","citationCount":"0","resultStr":"{\"title\":\"Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up.\",\"authors\":\"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\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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. 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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.</p><p><strong>Conclusions: </strong>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. 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引用次数: 0
摘要
背景：新一代药物洗脱支架经皮冠状动脉介入治疗（PCI）越来越多地应用于老年患者，这些患者通常有更多的合并症和更具有技术挑战性的靶病变。尽管如此，关于当代PCI支架在老年患者中的长期安全性和有效性的报道数据还很缺乏。方法：对一项大规模随机临床试验(BIONYX；clinicaltrials.gov:NCT02508714)比较了老年患者（≥75岁）PCI术后使用新型、更不透光的Onyx佐他莫司洗脱支架（ZES）和Orsiro西罗莫司洗脱支架（SES）的5年预后。我们评估了主要的复合终点靶血管衰竭（TVF：心源性死亡、靶血管心肌梗死或靶血管重建术）和几个次要终点。结果：在2488名试验参与者中，475名（19.1%）为老年人（79.5±3.5岁），其中165名（34.7%）为女性。主要终点TVF在支架间有显著差异（14.4% vs. 24.2%, HR: 0.60, 95% CI 0.39-0.93, plog-rank = 0.02）。时间到事件曲线显示了支架间TVF各组成部分的差异，但没有统计学意义。1年和5年随访的标志性分析显示，Onyx zes治疗的患者TVF发生率（7.8% vs.8.9%, p = 0.002）和靶血管重建率（3.0% vs.8.3%, p = 0.029）显著降低。此外，5年全因死亡率和几个综合终点的发生率更低(p)。结论：在老年所有患者中，Onyx治疗组的5年安全性和有效性主要终点以及几个次要终点的发生率低于Orsiro治疗组。对这个问题的进一步研究是有必要的。临床试验注册信息：https://clinicaltrials.gov/study/NCT02508714。
Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up.
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.
期刊介绍：
Clinical Research in Cardiology is an international journal for clinical cardiovascular research. It provides a forum for original and review articles as well as critical perspective articles. Articles are only accepted if they meet stringent scientific standards and have undergone peer review. The journal regularly receives articles from the field of clinical cardiology, angiology, as well as heart and vascular surgery.
As the official journal of the German Cardiac Society, it gives a current and competent survey on the diagnosis and therapy of heart and vascular diseases.
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