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DC Field | Value | Language |
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dc.contributor.author | Romaguera, Rafael | - |
dc.contributor.author | Salinas, Pablo | - |
dc.contributor.author | Gomez-Lara, Josep | - |
dc.contributor.author | Brugaletta, Salvatore | - |
dc.contributor.author | Gómez Menchero, Antonio | - |
dc.contributor.author | Romero, Miguel A. | - |
dc.contributor.author | García-Blas, Sergio | - |
dc.contributor.author | Ocaranza, Raymundo | - |
dc.contributor.author | Bordes, Pascual | - |
dc.contributor.author | Jimenez Kockar, Marcelo | - |
dc.contributor.author | Salvatella, Neus | - |
dc.contributor.author | Jiménez-Díaz, Víctor A. | - |
dc.contributor.author | Alameda, Mar | - |
dc.contributor.author | Trillo, Ramiro | - |
dc.contributor.author | Lee, Dae Hyun | - |
dc.contributor.author | Martín, Pedro | - |
dc.contributor.author | López-Benito, María | - |
dc.contributor.author | Freites, Alfonso | - |
dc.contributor.author | Pascual-Tejerina, Virginia | - |
dc.contributor.author | Hernández-Hernández, Felipe | - |
dc.contributor.author | García del Blanco, Bruno | - |
dc.contributor.author | Mohandes, Mohsen | - |
dc.contributor.author | Bosa, Francisco | - |
dc.contributor.author | Pinar, Eduardo | - |
dc.contributor.author | Roura, Gerard | - |
dc.contributor.author | Comin Colet, Josep | - |
dc.contributor.author | Fernández-Ortiz, Antonio | - |
dc.contributor.author | Macaya, Carlos | - |
dc.contributor.author | Rossello, Xavier | - |
dc.contributor.author | Sabaté, Manel | - |
dc.contributor.author | Pocock, Stuart J. | - |
dc.contributor.author | Gómez Hospital, Joan Antoni | - |
dc.date.accessioned | 2022-04-25T18:01:30Z | - |
dc.date.available | 2022-04-25T18:01:30Z | - |
dc.date.issued | 2022-04-01 | - |
dc.identifier.issn | 0195-668X | - |
dc.identifier.uri | http://hdl.handle.net/2445/185149 | - |
dc.description.abstract | Aim: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.44 to 0.96; pnon-inferiority <0.001; psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs 11.1%, HR 0.67, 95% CI 0.46 to 0.99; p = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusions: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Oxford University Press | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1093/eurheartj/ehab790 | - |
dc.relation.ispartof | European Heart Journal, 2022, vol. 43, num. 13, p. 1320-1330 | - |
dc.relation.uri | https://doi.org/10.1093/eurheartj/ehab790 | - |
dc.rights | cc by-nc (c) Romaguera, Rafael et al., 2022 | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc/4.0/ | - |
dc.source | Articles publicats en revistes (Ciències Clíniques) | - |
dc.subject.classification | Diabetis | - |
dc.subject.classification | Pròtesis de Stent | - |
dc.subject.classification | Malalties coronàries | - |
dc.subject.classification | Assaigs clínics | - |
dc.subject.other | Diabetes | - |
dc.subject.other | Stents (Surgery) | - |
dc.subject.other | Coronary diseases | - |
dc.subject.other | Clinical trials | - |
dc.title | Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 719033 | - |
dc.date.updated | 2022-04-25T18:01:30Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 34735004 | - |
Appears in Collections: | Articles publicats en revistes (Ciències Clíniques) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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File | Description | Size | Format | |
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719033.pdf | 1.3 MB | Adobe PDF | View/Open |
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