Comparative Clinical Outcomes of Amphilimus-Eluting Stents in Diabetic vs Nondiabetic Patients

초록

Background Patients with diabetes mellitus (DM) are at an increased risk of adverse events following percutaneous coronary intervention (PCI). The Cre8 EVO stent (CID), releasing amphilimus from laser-dug wells, has demonstrated specific benefits in diabetic populations. We aimed to explore the impact of DM on clinical outcomes in a large, real-world registry of all-comer patients treated with Cre8 and Cre8 EVO stents. Methods We did an investigator-initiated, prospective, single-arm observational trial at 28 sites in South Korea. The primary endpoint was a composite of cardiac death, target vessel–related myocardial infarction, and clinically driven repeat revascularization at 1 year. All-cause mortality was a key secondary endpoint. Results A total of 2,043 patients (66.0 ± 11 years, 76.2% male) were analyzed. Diabetic patients (n = 773) were more likely to be older, female, and have hypertension, dyslipidemia, or chronic kidney disease. There were 39 cases of primary events: 17 (2.5%) in the DM group and 22 (1.9%) in the non-DM group (P = 0.33). The DM group exhibited a higher rate of all-cause mortality (1.8% vs 0.9%; P = 0.06). The adjusted risk of 1-year primary endpoint was similar between the DM and non-DM groups (HR: 1.50; 95% CI: 0.72-3.12), with similar safety profiles. Conclusions PCI with amphilimus-eluting stents demonstrated excellent safety and effectiveness at 1 year in DM patients. This shows the potential for amphilimus-eluting stents to become a preferred option for patients with DM, prompting further investigation into their long-term benefits and mechanisms of action.