Amphilimus-eluting stents superior to zotarolimus stents in diabetics undergoing PCI: SUGAR trial
Spain: Cre8 EVO stents (polymer-free amphilimus-eluting stent) are superior to Resolute Onyx stents (polymer-based zotarolimus-eluting stent) in patients with diabetes undergoing PCI with regard to target lesion and target vessel failure composite outcomes at one year, show results from SUGAR trial. The study was published in the European Heart Journal on 04 November 2021.
Diabetes patients are at a higher 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 demonstrated clinical benefits in diabetes.
Against the above background, Rafael Romaguera, Hospital de Bellvitge - IDIBELL, University of Barcelona, Barcelona, Spain, and colleagues aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes and coronary artery disease.
For this purpose, the researchers performed an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Those with diabetes and requiring percutaneous coronary intervention (PCI) were included. A total of 1175 patients were randomly assigned in the ratio of 1:1 to receive Cre8 EVO or Resolute Onyx stents.
The primary endpoint was a 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.
Following were the key findings:
- 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].
- 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).
- Probable or definite stent thrombosis and all-cause death were not significantly different between groups.
"Our findings showed that in patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome," wrote the authors. "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."
Rafael Romaguera, MD, Pablo Salinas, MD, Josep Gomez-Lara, MD, PhD, Salvatore Brugaletta, MD, PhD, Antonio Gómez-Menchero, MD, Miguel A Romero, MD, Sergio García-Blas, MD, Raymundo Ocaranza, MD, Pascual Bordes, MD, Marcelo Jiménez Kockar, MD, Neus Salvatella, MD, Victor A Jiménez-Díaz, MD, Mar Alameda, MD, Ramiro Trillo, MD, Dae Hyun Lee, MD, Pedro Martín, MD, María López-Benito, MD, Alfonso Freites, MD, Virginia Pascual-Tejerino, MD, Felipe Hernández-Hernández, MD, Bruno García del Blanco, MD, Mohsen Mohandes, MD, Francisco Bosa, MD, Eduardo Pinar, MD, Gerard Roura, MD, PhD, Josep Comin-Colet, MD, PhD, Antonio Fernández-Ortiz, MD, PhD, Carlos Macaya, MD, PhD, Xavier Rossello, MD, PhD, Manel Sabate, MD, PhD, Stuart J Pocock, PhD, Joan A Gómez-Hospital, MD, PhD, the SUGAR trial Investigators, Amphilimus- versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease (SUGAR trial), European Heart Journal, 2021;, ehab790, https://doi.org/10.1093/eurheartj/ehab790