# Efficacy and safety of polymer-free amphilimus-eluting stent in patients with and without diabetes mellitus: A prospective, multicenter observational study

## TL;DR

A study found that a type of heart stent works safely and effectively in diabetic and non-diabetic patients.

## Contribution

The study evaluates the real-world effectiveness and safety of a polymer-free amphilimus-eluting stent in diabetic patients.

## Key findings

- The primary endpoint of cardiac events was similar between diabetic and non-diabetic patients.
- Diabetic patients had a higher all-cause mortality rate, but the difference was not statistically significant.
- The stent showed comparable safety and effectiveness in both groups at 12 months.

## Abstract

Patients with diabetes mellitus (DM) undergoing percutaneous coronary intervention face higher risks of restenosis and adverse cardiovascular outcomes compared to those without DM. This study compared the real-world safety and effectiveness of the Cre8/Cre8 EVO stents in patients with and without diabetes.

We performed 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 (MI), and any clinically driven repeat revascularization at 12 months. All-cause mortality was a key secondary endpoint. The adjusted outcomes of DM and non-DM groups were compared using 1:1 propensity score (PS) matching.

A total of 2,043 patients (66.0 ± 11.5 years of age; 76.2% male) were analyzed. Diabetic patients (n = 773; HbA1c 7.3 ± 1.4%) were more likely to be older, female, and have hypertension, dyslipidemia, or chronic kidney disease. Among these, 20.2% (156 patients) were using insulin. There were 54 cases of primary endpoint, 22 (cumulative incidence, 3.4%) in the DM group and 32 (3.0%) in the non-DM group (p = 0.61). The DM group exhibited a higher all-cause mortality rate compared to the non-DM group (2.1% vs. 1.3%; p = 0.19). The adjusted risk of 1-year primary endpoint was similar between the DM and non-DM groups (hazard ratio, 1.20; 95% confidence interval, 0.63–2.30), with comparable safety profiles.

In this real-world study, the DM group treated with amphilimus-eluting stents demonstrated sufficient safety and effectiveness at 12 months, with a similar occurrence of cardiovascular events compared to the non-DM group.