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Repisalud author Romaguera, Rafael author Salinas, Pablo author Gomez-Lara, Josep author Brugaletta, Salvatore author Gomez-Menchero, Antonio author Romero, Miguel A author Garcia-Blas, Sergio author Ocaranza, Raymundo author Bordes, Pascual author Kockar, Marcelo Jimenez author Salvatella, Neus author Jimenez-Diaz, Victor A author Alameda, Maria del Mar author Trillo, Ramiro author Lee, Dae Hyun author Martin, Pedro author Lopez-Benito, Maria author Freites, Alfonso author Pascual-Tejerina, Virginia author Hernandez-Hernandez, Felipe author Del Blanco, Bruno Garcia author Mohandes, Mohsen author Bosa, Francisco author Pinar, Eduardo author Roura, Gerard author Comin-Colet, Josep author Fernandez-Ortiz, Antonio author Macaya, Carlos author Rosselló, Xavier author Sabate, Manel author Pocock, Stuart J author Gomez-Hospital, Joan A author SUGAR Trial Investigators author Romaguera, Rafael author Salinas, Pablo author Gomez-Lara, Josep author Brugaletta, Salvatore author Gomez-Menchero, Antonio author Romero, Miguel A author Garcia-Blas, Sergio author Ocaranza, Raymundo author Bordes, Pascual author Kockar, Marcelo Jimenez author Salvatella, Neus author Jimenez-Diaz, Victor A author Alameda, Maria del Mar author Trillo, Ramiro author Lee, Dae Hyun author Martin, Pedro author Lopez-Benito, Maria author Freites, Alfonso author Pascual-Tejerina, Virginia author Hernandez-Hernandez, Felipe author Del Blanco, Bruno Garcia author Mohandes, Mohsen author Bosa, Francisco author Pinar, Eduardo author Roura, Gerard author Comin-Colet, Josep author Fernandez-Ortiz, Antonio author Macaya, Carlos author Rosselló, Xavier author Sabate, Manel author Pocock, Stuart J author Gomez-Hospital, Joan A author SUGAR Trial Investigators 2024-10-04T13:16:22Z 2024-10-04T13:16:22Z 2022-03-31 Romaguera R, Salinas P, Gomez-Lara J, Brugaletta S, Gomez-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):1320-30. 10.1093/eurheartj/ehab790 1522-9645 0195-668X European Heart Journal https://hdl.handle.net/20.500.13003/19436 34735004 L2017664609 2-s2.0-85125141974 https://hdl.handle.net/20.500.12105/23377 776936500010 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. eng Percutaneous coronary intervention Drug-eluting stents Diabetes mellitus Randomized trial Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial research article