SUGAR Trial Compares DES in Treating Patients With Diabetes Undergoing PCI

November 4, 2021—Results from SUGAR, a randomized, controlled, multicenter trial conducted exclusively in patients with diabetes mellitus (DM) and with minimum exclusion criteria, found that amphilimus-eluting stents (AES) were superior to zotarolimus-eluting stents (ZES) regarding target lesion and target vessel failure composite outcomes at 1 year.

The SUGAR findings were reported at TCT 2021, the 33rd annual scientific symposium of the Cardiovascular Research Foundation held November 4-6 online and in Orlando, Florida. The study was also published simultaneously by Rafael Romaguera, MD, et al online in the European Heart Journal.

As noted in TCT press release, a total of 463 million patients worldwide have diabetes. In the United States, 38% of patients undergoing percutaneous coronary intervention (PCI) have diabetes, accounting for approximately 250,000 patients in 2019 alone. Patients with diabetes are at high risk of adverse events after revascularization with contemporary drug-eluting stents (DES) 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, noted the press release.

According to TCT, SUGAR was composed of 1,175 patients with DM undergoing percutaneous revascularization at 23 hospitals in Spain. These patients 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 in both groups.

The primary endpoint was 1-year target lesion failure, which is a composite of cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target-lesion revascularization.

As summarized in the TCT press release, the SUGAR findings included the following:

• AES met the criteria for noninferiority compared to ZES (7.2% vs 10.9%; risk difference, -3.73%; 95% CI, -7.01 to -0.45; P < .001) as well as superiority (hazard ratio [HR], 0.65; 95% CI, 0.44-0.96; P = .03).
• 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 = .452).
• Target vessel MI was 5.3% for AES compared to 7.2% for ZES (HR 0.74; 95% CI, 0.44-1.23; P = .24).
• Target lesion revascularization was 2.4% for AES and 3.9% for ZES (HR 0.; 95% CI, 0.31-1.18; P = .058).

Among the secondary endpoints, AES versus ZES showed the following:

• Significantly lower target vessel failure (7.5% vs 11.1%; HR 0.67; 95% CI 0.46-0.99; P = .042)
• Significantly lower probable or definite stent thrombosis (1.4% vs 1.4%; HR, 1.00; 95% CI, 0.38-2.67; P = .994)
• Similar all-cause death (3.4% vs 5.0%; HR 0.69; 95% CI, 0.39-1.22; P = .201)

“SUGAR is the first powered trial to compare new-generation DES in patients with diabetes, and also the first to include a broad population of patients with diabetes,” commented Dr. Romaguera in the TCT press release. “In patients with diabetes mellitus undergoing percutaneous revascularization, the study found that AES were superior to Onyx ZES with a 35% reduction in the risk of target lesion failure at 1 year.” Dr. Romaguera is with Hospital de Bellvitge in Barcelona, Spain.