# Amphilimus versus zotarolimus stents bij diabetes: SUGAR gerandomiseerde trial

*geplaatst 2022-03-31 · Preventie · European heart journal · doi 10.1093/eurheartj/ehab790 · https://hartvaat.nl/2022/03/31/amphilimus-versus-zotarolimus-stents-bij-diabetes-sugar-gerandomiseerde-trial/*

SUGAR gerandomiseerde trial die amphilimus vergeleek met zotarolimus-eluting stents bij diabetespatiënten met coronairlijden.

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

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.

## Abstract (original, from the publication)

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.

Auteurs: 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

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Bron: European heart journal, https://doi.org/10.1093/eurheartj/ehab790. Bijgewerkt 2026-07-03T13:28:47Z. 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.