Results from SUGAR, a randomised controlled, multicentre trial conducted exclusively in patients with diabetes mellitus and with minimum exclusion criteria, found that amphilimus-eluting stents (AES) were superior to zotarolimus-eluting stents (ZES) with regard to target lesion and target vessel failure composite outcomes at one year. Findings were reported Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021; 4–6 November, Orlando USA and virtual) and published simultaneously in the European Heart Journal.
Patients with diabetes are at high risk of adverse events after revascularisation with contemporary drug-eluting stents and the little evidence available for these patients suggests equivalence between most current stent types. AES are thin-strut stents eluting a formulation of sirolimus with an amphiphilic carrier from laser-dug wells on the stent’s surface that have shown positive results in previous studies in patients with diabetes.
A total of 1,175 patients with diabetes mellitus undergoing percutaneous revascularization at 23 hospitals in Spain were randomly assigned 1:1 to receive AES (n=586) or ZES (n=589). The study included all-comers and in the case of multivessel disease, all lesions were treated with the allocated stent. Baseline patient characteristics were similar among both groups.
The primary endpoint was target-lesion failure at one year, a composite of cardiac death, target-vessel myocardial infarction (MI), and ischemia-driven target-lesion revascularisation. AES met the criteria for non-inferiority compared to ZES (7.2% versus 10.9%; risk difference, -3.73% [95% CI -7.01–0.45]; p <0.001) as well as superiority (HR 0.65, 95% CI 0.44-0.96, p=0.030). The cumulative incidence of cardiac death was 2.1% for AES and 2.7% for ZES (HR 0.75, 95% CI 0.36-1.59, p=0.452). In addition, target vessel MI was 5.3% for AES compared to 7.2% for ZES (HR 0.74, 95% CI 0.44-1.23, p=0.240) and target lesion revascularisation was 2.4% for AES and 3.9% for ZES (HR 0.60, 95% CI 0.31-1.18, p=0.058).
Among the secondary endpoints, AES had a significantly lower rate of target vessel failure than ZES (7.5% versus 11.1%, HR 0.67 [95% CI 0.46-0.99], p=0.042), whereas probable or definite stent thrombosis (1.4% versus 1.4%, HR 1.00 [95% CI 0.38-2.67], p=0.994) and all-cause death (3.4% versus 5.0%, HR 0.69 [95% CI 0.39- 1.22], p=0.201) were similar in both groups.
“SUGAR is the first powered trial to compare new-generation drug-eluting stents in patients with diabetes, and also the first to include a broad population of patients with diabetes,” said Rafael Romaguera, Hospital de Bellvitge (Barcelona, Spain). “In patients with diabetes mellitus undergoing percutaneous revascularisation, the study found that amphilimus-eluting stents were superior to Onyx-zotarolimus-eluting stents with a 35% reduction in the risk of target lesion failure at one year.”