1. Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.
- Author
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Romaguera R, Salinas P, Gomez-Lara J, Brugaletta S, Gómez-Menchero A, Romero MA, García-Blas S, Ocaranza R, Bordes P, Kockar MJ, Salvatella N, Jiménez-Díaz VA, Alameda M, Trillo R, Lee DH, Martín P, López-Benito M, Freites A, Pascual-Tejerina V, Hernández-Hernández F, Blanco BGD, Mohandes M, Bosa F, Pinar E, Roura G, Comin-Colet J, Fernández-Ortiz A, Macaya C, Rossello X, Sabate M, Pocock SJ, and Gómez-Hospital JA
- Subjects
- Humans, Prosthesis Design, Sirolimus analogs & derivatives, Sirolimus therapeutic use, Treatment Outcome, Coronary Artery Disease etiology, Coronary Artery Disease therapy, Diabetes Mellitus, Drug-Eluting Stents, Percutaneous Coronary Intervention methods
- 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., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2022
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