In patients with diabetes and coronary artery disease, Cre8 EVO stents, which release a formulation of sirolimus with an amphiphilic carrier from laser-dug reservoirs, were noninferior to contemporary polymer-based zotarolimus-eluting stents in terms of target-lesion failure composite outcomes, according to findings from the SUGAR trial presented at TCT 2021 and simultaneously published in the European Heart Journal.

Researchers led by Rafael Romaguera, MD, randomized a total of 1,175 patients with diabetes and requiring PCI from 23 sites in Spain to receive either the Cre8 EVO or a contemporary Resolute Onyx stent. 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 one year.

Overall results found 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group. Researchers also observed significantly lower rates of target-vessel failure in the Cre8 EVO group compared with the Resolute Onyx group (7.5% vs. 11.1%). Probable or definite stent thrombosis and all-cause death were not significantly different between the two groups. Additionally, an exploratory analysis for superiority at one year suggests that the Cre8 EVO stents might be superior to the Resolute Onyx stents with regard to the same outcome, based on the findings.

“Our study is the first powered trial to compare second-generation drug-eluting stents in patients with diabetes, and the first to show a meaningful reduction of events after drug-eluting stent implantation in diabetes since the TUXEDO trial,” the authors said. They added that SUGAR is also the first trial to include “a broad population of patients with diabetes (all-comers design), and therefore may be considered more representative of the real population with diabetes than previous trials.”

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT21, Drug-Eluting Stents, Diabetes Mellitus, Angiography, ACC International

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