Discussed here is a study of a head-to-head comparison of current stents that was designed to establish noninferiority for the treatment of coronary artery disease (CAD) in patients with diabetes, but ended up finding one that was superior to the other for the main endpoint of target lesion failure (TLF).

Novel stent achieves sweet success in a diabetic patient

At 1-year follow-up, the new-generation Cre8 EVO device demonstrated a 35% decrease in target lesion failure in patients with diabetes when compared to a conventional drug-eluting stent (DES). At one year, target lesion failure (TLF) rates were 7.2 per cent and 10.5 per cent, respectively, for the Cre8 EVO and Resolute Onyx stents.

The 3.73 per cent decrease in TLF at one year among those receiving the Cre8 EVO device confirmed noninferiority (P.001) and prompted the preplanned superiority analysis. When the significant advantage on the TLF endpoint (P =.03) was disaggregated, the Cre8 EVO stent was associated with numerically lower rates of cardiac death (2.1 per cent vs. 2.7 per cent), target vessel MI (5.3 per cent vs. 7.2 per cent), and target lesion revascularization (2.4 per cent vs. 3.9 per cent), according to the results of the SUGAR (Second-Generation Drug-Eluting Stents in Diabetes.

TLF rates were comparable at one year in an all-comer CAD group in prior research evaluating these devices, dubbed the ReCre8 trial. They remained comparable when an updated three-year study was given earlier in 2021 at the Cardiovascular Research Technologies symposium.

Unmet demand for diabetes-focused study

The reason for initiating a new study confined to diabetic patients was based on the population's increased risk. The risk of significant adverse cardiac events is almost twofold greater in individuals with diabetes than in those without diabetes two years following stent placement, even when drug-eluting stents are employed.

Both the Cre8 EVO and Resolute Onyx stents are drug-eluting and include current design, which enables marketing claims that they are acceptable for difficult patients; nonetheless, they vary in many ways.

Three characteristics distinguishing the Cre8 EVO stent

1. One is the lack of polymer, in contrast to the Resolute device's permanent polymer. This property impacts the anti-inflammatory drug's solubility and may account for the increased protection against ischemia events.
2. Another factor is the strut thickness, which varies between 70 and 80 mm for the Cre8 EVO and 92 to 102 mm for the Resolute Onyx. Strut thickness has been related to an increased risk of thrombus development in experimental trials, however, it is unknown if this small variation is clinically meaningful.
3. Additionally, the Cre8 EVO device elutes sirolimus, and the Resolute Onyx elutes zotarolimus. Again, experimental research shows that a stronger anti-inflammatory impact lessens the requirement for dual antiplatelet treatment (DAPT); this may provide a relative benefit in individuals at risk of bleeding.

SUGAR randomised 1,175 patients with diagnosed diabetes who were planned for percutaneous intervention (PCI) to one of two stents. The research was purposefully intended to have a limited number of exclusion criteria.

The SUGAR experiment 

Patients with non-ST-segment elevation myocardial infarction (MI) and those with chronic coronary artery disease were about equally split, although patients with STEMI were included, accounting for approximately 12% of the population. Almost all of the patients (about 95 per cent) had type 2 diabetes at the time of randomisation; roughly one-third were taking insulin.

SUGAR is the first randomised controlled experiment to compare next-generation drug-eluting stents in diabetic patients. At the time of the meeting's presentation, the SUGAR findings were published in the European Heart Journal.

The specialists stated:

"This research is like sugar to us because now that we have a stent that is specifically designed and suited for the diabetic population, it will change how they practise."

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The author is a practising super specialist from New Delhi.