%0 Journal Article
%A Romaguera, Rafael
%A Salinas, Pablo
%A Gomez-Lara, Josep
%A Brugaletta, Salvatore
%A Gómez-Menchero, Antonio
%A Romero, Miguel A
%A García-Blas, Sergio
%A Ocaranza, Raymundo
%A Bordes, Pascual
%A Kockar, Marcelo Jiménez
%A Salvatella, Neus
%A Jiménez-Díaz, Victor A
%A Alameda, Mar
%A Trillo, Ramiro
%A Lee, Dae Hyun
%A Martín, Pedro
%A López-Benito, María
%A Freites, Alfonso
%A Pascual-Tejerina, Virginia
%A Hernández-Hernández, Felipe
%A Blanco, Bruno García Del
%A Mohandes, Mohsen
%A Bosa, Francisco
%A Pinar, Eduardo
%A Roura, Gerard
%A Comin-Colet, Josep
%A Fernández-Ortiz, Antonio
%A Macaya, Carlos
%A Rossello, Xavier
%A Sabate, Manel
%A Pocock, Stuart J
%A Gómez-Hospital, Joan A
%A SUGAR trial investigators
%T Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.
%D 2022
%U http://hdl.handle.net/10668/19766
%X 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. 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  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. ClinicalTrials.gov: NCT03321032.
%K Diabetes mellitus
%K Drug-eluting stents
%K Percutaneous coronary intervention
%K Randomized trial
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