Sweet news for new stent: SUGAR trial finds polymer-free stent non-inferior to ZES in patients with diabetes.

Key Points:

• • Patients with diabetes who undergo PCI are more likely to have target lesion failure and target vessel revascularization than their non-diabetic counterparts.
  • The Cre8 EVO stent is polymer-free with thin stent struts and elutes sirolimus via an amphiphilic carrier to promote drug delivery.
  • After diabetic participants were randomized in a 1:1 fashion the Cre8 EVO not only met noninferiority for target lesion failure, but suggested superiority for the same endpoint when compared to the Resolute Onyx stent.

Despite the advancement in current generation drug eluting stents in the prevention of stent thrombosis and restenosis, patients with diabetes continue to have worse outcomes than their nondiabetic counterparts. Higher rates of target lesion failure plague diabetics regardless of which drug-eluting stent is implanted. Investigators of the SUGAR trial hypothesized that poor outcomes in diabetics can be overcome by implementing changes to the contemporary stent’s design. Dr. Rafael Romaguera presented the trial’s results at a late breaking session during the 33^rd annual TCT conference earlier today.

The Cre8 EVO, a polymer-free, thin-strutted stent releases a medium dose of sirolimus formulated with an amphiphilic carrier from drug reservoirs on its surface, was thought to be an ideal choice for patients with diabetes: thin struts would combat restenosis, and the amphiphilic carrier would allow for drug delivery in typically-resistant patients. Furthermore, it had been shown to have clinical benefits for diabetic patients in smaller clinical trials.

The trial was a prospective, assessor-blinded, randomized control trial that took place in 23 hospitals across Spain. It included all patients with diabetes undergoing coronary angiography and percutaneous coronary intervention. There were no exclusions based on vessel anatomy, clinical presentation, complexity of lesions, or the number of stents needed. After angiography, patients were randomized in a 1:1 fashion to receive either the Cre8 EVO stent, or a Resolute Onyx (zotarolimus-eluting) stent.

Stent Comparisons
The Cre8 EVO has a stent strut thickness of 70 µm for the 2.0-2.5 mm stents and 80 µm for the larger stents. The Resolute Onyx, also a balloon expandable stent, has a strut thickness of 81 µm for the 2.0-3.5 mm stents and 91 µm for the larger stents.

586 participants received the investigational stent, and 589 received the Resolute Onyx. Participants were mostly male with preserved left ventricular ejection fractions. One third of the participants in either group were treated with insulin before their procedure. About half of the patients presented with acute coronary syndromes, either NSTEMI or STEMI. Only 40% of patients in either group had single vessel diseases, with Type A lesions accounting for less than 10% of the lesions in either group.  Clopidogrel was the most common P2Y-12 inhibitor prescribed (48%), followed by ticagrelor (42%) and prasugrel (9%).  At 12 months, there were significantly fewer target lesion failures (7.2% vs 10.9% [HR 0.65, CI 0.44-0.96, p = 0.030 for superiority, p<0.001 for noninferiority]). This was driven mostly by rates of target lesion revascularization. There was no significant difference in cardiac death or target vessel MI among the two groups. Aside from target vessel failure, all secondary endpoints were not found to be different between the two groups.

In an interview with Dr. Michael Gibson, Dr. Rafael Romaguera (Barcelona, Spain) stated that the results of the trial are promising that he would consider using Cre8 EVO as his preferred stent in all patients with diabetes. After Dr. Romaguera’s presentation, the panel, which included David Kandzari of Piedmont Heart Institute in Atlanta, and Robert Byrne of Mater Hospital in Dublin, agreed that the trial’s results were promising and favored the Cre8 EVO stent. They cautioned, however, that longer-term follow up and more studies are required to determine both delayed outcomes and a biologic plausibility before switching to exclusive use of the stents in diabetic patients.

The trial’s results were published simultaneously in the European Heart Journal.