{"id":"b4374bf3b5b3","type":"article","url":"https://hartvaat.nl/2022/03/31/amphilimus-versus-zotarolimus-stents-bij-diabetes-sugar-gerandomiseerde-trial/","title":"Amphilimus versus zotarolimus stents bij diabetes: SUGAR gerandomiseerde trial","title_en":"Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.","category":"preventie","category_label":"Preventie","professions":["cardioloog"],"tags":["select-trial"],"journal":"European heart journal","doi":"10.1093/eurheartj/ehab790","source_url":"https://doi.org/10.1093/eurheartj/ehab790","authors":["Rafael Romaguera","Pablo Salinas","Josep Gomez-Lara","Salvatore Brugaletta","Antonio Gómez-Menchero","Miguel A Romero","Sergio García-Blas","Raymundo Ocaranza","Pascual Bordes","Marcelo Jiménez Kockar","Neus Salvatella","Victor A Jiménez-Díaz","Mar Alameda","Ramiro Trillo","Dae Hyun Lee","Pedro Martín","María López-Benito","Alfonso Freites","Virginia Pascual-Tejerina","Felipe Hernández-Hernández","Bruno García Del Blanco","Mohsen Mohandes","Francisco Bosa","Eduardo Pinar","Gerard Roura","Josep Comin-Colet","Antonio Fernández-Ortiz","Carlos Macaya","Xavier Rossello","Manel Sabate","Stuart J Pocock","Joan A Gómez-Hospital"],"significance":6,"published":"2022-03-31","source_date":"2022-03-31","image":"","kennis":["https://hartvaat.nl/kennis/lipiden/lpa-meten-wanneer-waarom/","https://hartvaat.nl/kennis/cardiometabool/cardiometabool-spreekuur/"],"congress":"","summary_en":"The SUGAR randomized trial compared amphilimus-eluting with zotarolimus-eluting stents in diabetic patients with coronary disease, testing a newer polymer-free technology designed for improved healing in the diabetic vasculature.","created":"2026-07-03T10:29:40Z","updated":"2026-07-03T13:28:47Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"SUGAR gerandomiseerde trial die amphilimus vergeleek met zotarolimus-eluting stents bij diabetespatiënten met coronairlijden.","abstract_original":"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; Psuperiority = 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. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03321032."}