The new-generation Cre8 EVO device showed a 35% reduction in target lesion failure (TLF) in patients with diabetes at 1-year follow-up, compared to a contemporary drug-eluting stent (DES), new trial data shows. Reported on Thursday at Transcatheter Cardiovascular Therapeutics (TCT) 2021 in Orlando, Florida, the study compared clinical outcomes of new-generation Cre8 EVO stents to contemporary Resolute Onyx DES in patients with diabetes mellitus (DM) and coronary artery disease (CAD) – finding that the newer Cre8 EVO stent has a 0.65 hazard ratio in a pre-defined superiority analysis. “SUGAR is the first powered trial to compare new-generation DES in patients with diabetes, and also the first to include a broad population of patients with diabetes,” explained lead researcher Rafael Romaguera from Bellvitge University Hospital in Barcelona, Spain. Diabetes risk Speaking at a TCT 2021 press conference, Romaguera noted that there are 463 million patients with diabetes worldwide and that 38% of percutaneous coronary interventions (PCI) performed in the U.S. are performed in patients with diabetes – meaning that nearly 250,000 diabetic patients are treated with DES in the U.S. every year. However, he warned that clinical outcomes from contemporary DES "are far from good" for diabetic patients, noting that patients with DM who are treated with DES have twice the risk of a burst event compared to a non-diabetic patient. Furthermore, patients with DM and multivessel disease have an increased mortality risk when treated with DES compared to if treated surgically via coronary artery bypass grafting (CABG), he said. While the Cre8 EVO is a new-generation stent that has shown promising results, Romaguera noted that there were no adequately powered trials to compare the stent with existing DES until now. Trial details Romaguera and his colleagues enrolled 1175 patients into the SUGAR randomized controlled trial, with 586 assigned to Cre8 EVO stents and 589 assigned to Resolute Onyx stents. Of these, 586 Cre8 EVO patients and 571 Resolute Onyx fully completed follow-up and were included in the intention-to-treat analysis. The primary endpoint was TLF at 1-year follow-up, which is a composite of cardiac death, any myocardial infarction (not clearly attributable to a non-target vessel), or clinically indicated target-lesion revascularization, he noted. Analysis revealed that the primary endpoint occurred in 7.2% of patients allocated to the Cre8 EVO stent and 10.9% of patients receiving the Resolute Onyx stent – meaning that the pre-defined noninferiority analysis was met, with an absolute difference of -3.7% (95% confidence interval [CI], -7.01 to -0.45, p<0.001 for noninferiority). Furthermore, they reported a hazard ratio of 0.65 (95% CI, 0.44 to 0.96) with p=0.030 for superiority under a pre-defined superiority analysis, meaning that use of the Cre8 EVO stent resulted in a 35% risk reduction, noted Romaguera. While dual antiplatelet therapy (DAPT) was similar for both groups at 1- and 6-month follow-up, the frequency of DAPT was higher in the Resolute Onyx group at 12 months, he added. A sweet result? Commenting on the results of the trial at the press conference, Gennaro Sardella, MD, an interventional cardiologist from the Policlinico Umberto I hospital in Rome, said the study was a “great result.” “I think that this study is sweet like sugar for us because now we have a stent that is dedicated and that is fitted for the diabetic population,” said the Italian expert. Sardella added that the efficacy and safety aspects of stents are interconnected, noting that “when we have a very efficient DES, we can a very safe DES." The commenter noted that a less effective DES will mean that events occur that will restart DAPT, "and thus you could have more bleeding." Romaguera commented that the research team believed the increased incidence of DAPT in the Resolute Onyx group occurred because there were more ischemic events. “If you have a new MI or a new PCI in a target vessel, then you restart DAPT,” he noted. However, panelists at the press conference also noted that while the new findings are “very promising” 1-year follow-up data are never sufficient to designate a new DES as “the new default.” Also commenting in the session, David Kandzari, MD, from the Piedmont Heart Institute, Atlanta, noted that a larger evidence base than a single trial is needed to change practice. "Rather than look at any singular trial … we look at a totality of the evidence,” he noted. “If we see more data with this particular stent design, demonstrating a differential efficacy and safety in diabetic patients, then that would certainly lead to greater adoption.” The SUGAR trial was funded by the Spanish Society of Cardiology.