Trial reportClinical research in cardiology : official journal of the German Cardiac Society2025
Elderly patients treated with Onyx versus Orsiro drug-eluting coronary stents in a randomized clinical trial with long-term follow-up.
Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02508714 (Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents (BIONYX): A Randomized Trial With Stent Evaluation in All-comers IV (TWENTE IV)
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Authors and funding
13 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundPercutaneous 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.
methodsThis 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.
resultsOf 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
conclusionsIn 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.
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