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Title: Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial
Author: Romaguera, Rafael
Salinas, Pablo
Gomez-Lara, Josep
Brugaletta, Salvatore
Gómez Menchero, Antonio
Romero, Miguel A.
García-Blas, Sergio
Ocaranza, Raymundo
Bordes, Pascual
Jimenez Kockar, Marcelo
Salvatella, Neus
Jiménez-Díaz, Víctor A.
Alameda, Mar
Trillo, Ramiro
Lee, Dae Hyun
Martín, Pedro
López-Benito, María
Freites, Alfonso
Pascual-Tejerina, Virginia
Hernández-Hernández, Felipe
García del Blanco, Bruno
Mohandes, Mohsen
Bosa, Francisco
Pinar, Eduardo
Roura, Gerard
Comin Colet, Josep
Fernández-Ortiz, Antonio
Macaya, Carlos
Rossello, Xavier
Sabaté, Manel
Pocock, Stuart J.
Gómez Hospital, Joan Antoni
Keywords: Diabetis
Pròtesis de Stent
Malalties coronàries
Assaigs clínics
Stents (Surgery)
Coronary diseases
Clinical trials
Issue Date: 1-Apr-2022
Publisher: Oxford University Press
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.
Note: Reproducció del document publicat a:
It is part of: European Heart Journal, 2022, vol. 43, num. 13, p. 1320-1330
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ISSN: 0195-668X
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))
Articles publicats en revistes (Ciències Clíniques)

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