Amphilimus-eluting stents: As good as zotarolimus-eluting stents in patients with diabetes?
The use of amphilimus-eluting stents (AES) in patients with diabetes mellitus undergoing percutaneous revascularization was less likely to result in target lesion or target vessel failure compared with zotarolimus-eluting stents (ZES) at 1 year, according to findings of the SUGAR trial presented at TCT 2021.
“In patients with diabetes mellitus undergoing percutaneous revascularization, the study found that amphilimus-eluting stents were superior to Onyx-zotarolimus-eluting stents with a 35 percent reduction in the risk of target lesion failure at 1 year,” remarked Dr Rafael Romaguera from the Hospital de Bellvitge and University of Barcelona, Barcelona, Spain.
The multicentre, investigator-initiated trial involved 1,175 adults (with 1,548 diseased vessels) with diabetes mellitus and an indication for percutaneous coronary intervention (PCI) who underwent percutaneous revascularization at 23 hospitals in Spain. They were randomized 1:1 to receive either AES or ZES. All patients received dual antiplatelet therapy (DAPT) for ≥1 month post-procedure. Individuals who were pregnant, had a life expectancy of <2 years, cardiogenic shock at presentation, undergoing mechanical ventilation, or with contraindication for ≥1 month of DAPT were excluded.
Thirty-two percent of patients were on insulin. Fifty-one percent had multivessel disease, with all lesions treated with the same stent.
At 1 year, target lesion failure, defined as cardiac death, target vessel myocardial infarction (MI), and ischaemia-driven target lesion revascularization, occurred in 7.2 and 10.9 percent of patients who received AES and ZES, respectively, with AES demonstrating noninferiority to ZES (risk difference, -3.73 percent, 95 percent confidence interval [CI], -7.01 to -0.45; pone-sided<0.001). Exploratory analysis showed superiority of AES over ZES (hazard ratio [HR], 0.65, 95 percent CI, 0.44–0.96; ptwo-sided=0.030). [TCT 2021, Late Breaking Trials; Eur Heart J 2021;doi:10.1093/eurheartj/ehab790]
Cardiac death occurred in 2.1 and 2.7 percent of patients who received AES and ZES, respectively (HR, 0.75, 95 percent CI, 0.36–1.59; p=0.452) and target vessel MI in 5.3 and 7.2 percent, respectively (HR, 0.74, 95 percent CI, 0.44–1.23; p=0.240). There was a trend toward a reduction in major adverse cardiac events with AES vs ZES (11.7 percent vs 15.7 percent; HR, 0.74, 95 percent CI, 0.53–1.02; p=0.067), as well as target lesion revascularization (2.4 percent vs 3.9 percent; HR, 0.60, 95 percent CI, 0.31–1.18; p=0.058).
“Importantly, the curves of target lesion revascularization began to diverge at 8-month follow-up, the time-point when restenosis usually begins to become clinically evident,” noted the authors. “Considering the complexity of diabetic patients, a significant number of events may be expected after the first year of follow-up.”
The incidence of the secondary endpoint of target vessel failure was significantly lower with AES compared with ZES (7.5 percent vs 11.1 percent; HR, 0.67, 95 percent CI, 0.46–0.99; p=0.042). Probable or definite stent thrombosis occurred at a comparable rate between the AES and ZES groups (1.4 percent in each group; HR, 1.00, 95 percent CI, 0.38–2.67; p=0.994), as did all-cause death (3.4 percent vs 5.0 percent; HR, 0.69, 95 percent CI, 0.39–1.22; p=0.201).
“[Patients with diabetes mellitus] often have symptomatic coronary artery disease and, as a consequence, percutaneous revascularization of patients with diabetes using drug-eluting stents is commonly performed worldwide,” said Romaguera and co-authors. “However, results of PCI with contemporary drug-eluting stents are far from good,” they added.
“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,” Romaguera said.
The authors noted that this, along with the minimal exclusion criteria, suggest that the findings may be representative of the general population with diabetes.
According to the authors, improved drug diffusion as well as thinner stent struts with AES may be behind the improved outcomes in patients with diabetes.