Clinical outcomes after permanent polymer or polymer‐free stent implantation in patients with diabetes mellitus: The ReCre8 diabetes substudy

OBJECTIVES: The purpose of this analysis was to compare target‐lesion failure (TLF) of a permanent polymer zotarolimus‐eluting stent (PP‐ZES) versus a polymer‐free amphilimus‐eluting stent (PF‐AES) in diabetics. BACKGROUND: The improvement of outcomes with new‐generation drug‐eluting stent as seen in the general population is less pronounced among diabetics. The PF‐AES introduces an elution‐technology with potential enhanced performance in diabetics. METHODS: In this subanalysis of the ReCre8 trial, patients were randomized to either a PP‐ZES or PF‐AES after stratification for diabetes and troponin status. The primary device‐oriented endpoint was TLF, a composite of cardiac death, target‐vessel myocardial infarction and target‐lesion revascularization. RESULTS: In the ReCre8 trial, 304 (20%) patients were diabetic and 96 (6%) had insulin‐dependent diabetes mellitus. There was no statistically significant difference between the two study arms regarding the primary endpoint (PP‐ZES 7.2% vs. PF‐AES 4.0%; p = .21), although the composite of net adverse clinical events was higher in the PP‐ZES arm (15.7 vs. 8.0%; p = .035). Stent thrombosis was low in both groups with no cases in the PP‐ZES arm and 1 case in the PF‐AES arm (p = .32). Regarding insulin‐treated diabetics, TLF was higher in the PP‐ZES arm (14.9 vs. 2.1%; p = .022). CONCLUSIONS: Diabetics could potentially benefit from a dedicated stent, releasing sirolimus with a lipophilic carrier (amphilimus‐formulation). Future trials should confirm the potential benefit of a PF‐AES in this population.