Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial.

Abstract

Patients with diabetes mellitus (DM) have an elevated risk of late events after percutaneous coronary intervention (PCI). The Second-generation Drug-eluting Stents in Diabetes (SUGAR) trial (NCT03321032) compared amphilimus-eluting stents (AESs) and onyx-zotarolimus-eluting stents (O-ZESs) in this population. To report the co-primary endpoint comparing target lesion failure (TLF) between AES and O-ZES at 2 years and the extended follow-up at 3 years. The SUGAR trial enrolled 1175 patients with DM across 23 centres in a randomised (1:1 AES (Cre8EVO) or O-ZES (Resolute Onyx)) assessor-blinded design. The primary endpoint, assessed with a Cox proportional hazards model, was TLF (a composite of cardiac death, target vessel myocardial infarction or ischaemia-driven target lesion revascularisation). Secondary endpoints included all-cause mortality, stent thrombosis and major adverse cardiac events. At 2 years, TLF occurred in 60 (10.4%) patients in the AES group and 71 (12.1%) in the O-ZES group; HR 0.84 (95% CI 0.60 to 1.19), p=0.331. At 3 years, TLF occurred in 66 (11.4%) of the AES group compared with 87 (14.9%) of the O-ZES group (HR 0.77; 95% CI 0.56 to 1.06; p=0.106). Landmark analysis revealed no significant differences in TLF rates between 1 and 3 years (HR 1.07; 95% CI 0.62 to 1.87; p=0.801). Rates of individual components of the primary endpoint were comparable between groups. No significant differences were observed in secondary endpoints. The SUGAR trial demonstrates that AES and O-ZES provide comparable long-term efficacy in preventing TLF in patients with DM undergoing PCI. These findings support the use of either stent type and highlight the importance of further long-term studies to optimise outcomes. NCT03321032.