RT Journal Article
T1 Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.
A1 Romaguera, Rafael
A1 Salinas, Pablo
A1 Gomez-Lara, Josep
A1 Brugaletta, Salvatore
A1 Gomez-Menchero, Antonio
A1 Romero, Miguel A
A1 Garcia-Blas, Sergio
A1 Ocaranza, Raymundo
A1 Bordes, Pascual
A1 Jimenez-Kockar, Marcelo
A1 Salvatella, Neus
A1 Jimenez-Diaz, Victor A
A1 Alameda, Mar
A1 Trillo, Ramiro
A1 Lee, Dae Hyun
A1 Martin, Pedro
A1 Lopez-Benito, Maria
A1 Freites, Alfonso
A1 Pascual-Tejerina, Virginia
A1 Hernandez-Hernandez, Felipe
A1 Garcia-Del-Blanco, Bruno
A1 Mohandes, Mohsen
A1 Bosa, Francisco
A1 Pinar, Eduardo
A1 Roura, Gerard
A1 Comin-Colet, Josep
A1 Fernandez-Ortiz, Antonio
A1 Macaya, Carlos
A1 Rossello, Xavier
A1 Sabate, Manel
A1 Pocock, Stuart J
A1 Gomez-Hospital, Joan A
K1 Diabetes mellitus
K1 Drug-eluting stents
K1 Percutaneous coronary intervention
K1 Randomized trial
AB 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. 
PB Oxford University Press
YR 2021
FD 2021-12-10
LK http://hdl.handle.net/10668/19766
UL http://hdl.handle.net/10668/19766
LA en
NO Romaguera R, Salinas P, Gomez-Lara J, Brugaletta S, Gómez-Menchero A, Romero MA, et al. Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial. Eur Heart J. 2022 Mar 31;43(13):1320-1330
DS RISalud
RD Jul 6, 2025