Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial

• Published in: European heart journal Vol. 43; no. 13; pp. 1320 - 1330
• Main Authors: Romaguera, Rafael, Salinas, Pablo, Gomez-Lara, Josep, Brugaletta, Salvatore, Gómez-Menchero, Antonio, Romero, Miguel A, García-Blas, Sergio, Ocaranza, Raymundo, Bordes, Pascual, Kockar, Marcelo Jiménez, Salvatella, Neus, Jiménez-Díaz, Victor A, Alameda, Mar, Trillo, Ramiro, Lee, Dae Hyun, Martín, Pedro, López-Benito, María, Freites, Alfonso, Pascual-Tejerina, Virginia, Hernández-Hernández, Felipe, Blanco, Bruno García del, Mohandes, Mohsen, Bosa, Francisco, Pinar, Eduardo, Roura, Gerard, Comin-Colet, Josep, Fernández-Ortiz, Antonio, Macaya, Carlos, Rossello, Xavier, Sabate, Manel, Pocock, Stuart J, Gómez-Hospital, Joan A
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 31.03.2022
• Subjects: Coronary Artery Disease - etiology; Coronary Artery Disease - therapy; Diabetes Mellitus; Drug-Eluting Stents; Fast Track Clinical Research; Humans; Percutaneous Coronary Intervention - methods; Prosthesis Design; Sirolimus - analogs & derivatives; Sirolimus - therapeutic use; Treatment Outcome; Percutaneous coronary intervention; Randomized trial; Diabetes mellitus; Drug-eluting stents
• ISSN: 0195-668X; 1522-9645; 1522-9645
• DOI: 10.1093/eurheartj/ehab790

Abstract 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. Graphical Abstract Graphical Abstract In the SUGAR trial, 1175 patients with diabetes mellitus and coronary artery disease were randomly assigned to receive Cre8 EVO or Resolute Onyx stents. Patients allocated to Cre8 EVO stents had a reduced risk of target lesion failure at 1-year follow-up.