Romaguera, RafaelSalinas, PabloGomez-Lara, JosepBrugaletta, SalvatoreGómez-Menchero, AntonioRomero, Miguel AGarcía-Blas, SergioOcaranza, RaymundoBordes, PascualKockar, Marcelo JiménezSalvatella, NeusJiménez-Díaz, Victor AAlameda, MarTrillo, RamiroLee, Dae HyunMartín, PedroLópez-Benito, MaríaFreites, AlfonsoPascual-Tejerina, VirginiaHernández-Hernández, FelipeBlanco, Bruno García DelMohandes, MohsenBosa, FranciscoPinar, EduardoRoura, GerardComin-Colet, JosepFernández-Ortiz, AntonioMacaya, CarlosRossello, XavierSabate, ManelPocock, Stuart JGómez-Hospital, Joan ASUGAR trial investigators2023-05-032023-05-032022http://hdl.handle.net/10668/19766Patients 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.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/Diabetes mellitusDrug-eluting stentsPercutaneous coronary interventionRandomized trialCoronary Artery DiseaseDiabetes MellitusDrug-Eluting StentsHumansPercutaneous Coronary InterventionProsthesis DesignSirolimusTreatment Outcomeresearch article34735004open access10.1093/eurheartj/ehab7901522-9645PMC8970998https://academic.oup.com/eurheartj/article-pdf/43/13/1320/43220119/ehab790.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8970998/pdf