Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial

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 ha...

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Detalles Bibliográficos
Autores: Romaguera, Rafael, Salinas, Pablo, Gomez-Lara, Josep, Brugaletta, Salvatore, Gomez-Menchero, Antonio, Romero, Miguel A, Garcia-Blas, Sergio, Ocaranza, Raymundo, Bordes, Pascual, Kockar, Marcelo Jimenez, Salvatella, Neus, Jimenez-Diaz, Victor A, Alameda, Maria del Mar, Trillo, Ramiro, Lee, Dae Hyun, Martin, Pedro, Lopez-Benito, Maria, Freites, Alfonso, Pascual-Tejerina, Virginia, Hernandez-Hernandez, Felipe, Del Blanco, Bruno Garcia, Mohandes, Mohsen, Bosa, Francisco, Pinar, Eduardo, Roura, Gerard, Comin-Colet, Josep, Fernandez-Ortiz, Antonio, Macaya, Carlos, Rosselló, Xavier, Sabate, Manel, Pocock, Stuart J, Gomez-Hospital, Joan A, SUGAR Trial Investigators
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/23377
Acceso en línea:https://hdl.handle.net/20.500.12105/23377
Access Level:acceso abierto
Palabra clave:Percutaneous coronary intervention
Drug-eluting stents
Diabetes mellitus
Randomized trial
Resultado del Tratamiento
Diabetes Mellitus
Stents Liberadores de Fármacos
Humanos
Enfermedad de la Arteria Coronaria
Intervención Coronaria Percutánea
Sirolimus
Diseño de Prótesis
Treatment Outcome
Humans
Coronary Artery Disease
Prosthesis Design
Drug-Eluting Stents
Percutaneous Coronary Intervention
Descripción
Sumario: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): 0.44-0.96; Pnon-inferiority < 0.001; P-superiority = 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: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusion: 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.

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