Comparing amphilimus and zotarolimus-eluting stents in patients with diabetes and coronary heart disease.

This study compared Cre8 EVO (amphilimus-eluting) stents to Resolute Onyx (zotarolimus-eluting) stents in patients with diabetes and CAD undergoing percutaneous coronary intervention (PCI). The authors concluded that Cre8 EVO stents were similar or better than Resolute Onyx stents in these patients.

Coronary artery disease (CAD) is a condition that involves the narrowing and blockage of coronary arteries and can lead to heart attacks, strokes, and death. Patients with diabetes have an increased risk of CAD. They frequently need to undergo to restore blood flow to the heart with a PCI. PCI is a minimally invasive procedure that uses stents to remove blockages in the heart blood vessels. Drug-eluting stents (DES) contain an anti-clotting medication that is slowly released into the blood-vessel to prevent it from blocking again (stent failure). However, there are some concerns with the effectiveness of conventional DES in patients with diabetes.

Cre8 EVO stents (CID S.p.A, Saluggia, Italy) are thin-strut stents that combine a medium dose of sirolimus with a carrier for more effective drug delivery within the vessel wall. Unlike conventional stents, Cre8 EVO is polymer-free and has been shown to be beneficial in patients with diabetes in several studies. The Resolute Onyx stent is a DES that releases the drug zotarolimus to prevent coronary artery re-narrowing over time. There is a need to investigate the equivalence of Cre8 EVO and Resolute Onyx stents (Medtronic, Minneapolis, MN, USA) in patients with diabetes.

This study included 1175 patients with diabetes and CAD who needed a PCI. Patients were randomly assigned to receive either Cre8 EVO stents (586) or Resolute Onyx stents (589). Target lesion failure was defined as cardiac death, heart attack in the target-vessel, or a need for revascularization in the target vessel (another PCI). The follow-up period was 12 months.

After 1 year, target-lesion failure occurred in 7.5% of patients that received Cre8 EVO stents compared to 11.1% of patients that had Resolute Onyx stents. There was a lower risk of needing a new PCI with the Cre8 EVO stents (2.4%) compared to the Resolute Onyx stents (3.9%). There was also a lower risk of major heart events (heart attack or death) with the Cre8 EVO stents (11.7%) compared to the Resolute Onyx stents (15.7%). 

The study found that Cre8 EVO stents improved vessel outcomes compared to Resolute Onyx stents in patients with diabetes.

The study had around 50% of patients with only one vessel disease so results may not apply to patients with more complex heart disease. The follow-up of 1 year was short in duration.