Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial. (10th December 2021)

• Record Type: Journal Article
• 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;
• Is Part Of: European heart journal. Volume 43:Number 13(2022)
• Page Start: 1320
• Page End: 1330
• Publication Date: 2021-12-10
• Subjects: Percutaneous coronary intervention -- Drug-eluting stents -- Diabetes mellitus -- Randomized trial; Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; 616.12005
• DOI: 10.1093/eurheartj/ehab790
• Languages: English
• ISSNs: 0195-668X

Abstract

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; P non-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. Clinical trial registration: ClinicalTrials.gov: NCT03321032. Graphical Abstract: