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

Loading...
Thumbnail Image

Date

2022

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

Advisors

Journal Title

Journal ISSN

Volume Title

Publisher

Metrics
Google Scholar
Export

Research Projects

Organizational Units

Journal Issue

Abstract

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. 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.

Description

MeSH Terms

Coronary Artery Disease
Diabetes Mellitus
Drug-Eluting Stents
Humans
Percutaneous Coronary Intervention
Prosthesis Design
Sirolimus
Treatment Outcome

DeCS Terms

CIE Terms

Keywords

Diabetes mellitus, Drug-eluting stents, Percutaneous coronary intervention, Randomized trial

Citation