Long‐term follow‐up of contemporary drug‐eluting stent implantation in diabetic patients: Subanalysis of a randomized controlled trial

Abstract

AbstractObjectiveThe elevated risk of adverse events following percutaneous coronary intervention in diabetic patients persists with newer‐generation DES. The polymer‐free amphilimus‐eluting stent (PF‐AES) possesses characteristics with a potentially enhanced performance in patients with diabetes. Data from the 1‐year follow‐up period has been previously published. The aim of this subanalysis was to assess long‐term performance of two contemporary drug‐eluting stents (DES) in a diabetic population.MethodsIn the ReCre8 trial, patients were stratified for diabetes and troponin status, and randomized to implantation of a permanent polymer zotarolimus‐eluting stent (PP‐ZES) or PF‐AES. The primary endpoint was target‐lesion failure (TLF), a composite of cardiac death, target‐vessel myocardial infarction and target‐lesion revascularization. Clinical outcomes between discharge and 3 years follow‐up were assessed.ResultsA total of 302 patients with diabetes were included in this analysis. After 3 years, TLF occurred in 12.5% of PP‐ZES patients versus 10.0% in PF‐AES patients (p = 0.46). Similarly, the separate components of TLF were comparable between the two study arms. The secondary composite endpoint of NACE was higher in the PP‐ZES arm with 45 cases (29.6%) versus 30 cases (20.0%) in the PF‐AES arm (p = 0.036). In the insulin‐dependent diabetic population, TLF occurred in 19.1% of PP‐ZES patients versus 10.4% of PF‐AES patients (p = 0.21). NACE occurred in 40.4% of PP‐ZES patients versus 27.1% of PF‐AES patients (p = 0.10).ConclusionsThis subanalysis shows that the use of PF‐AES results in similar clinical outcomes as compared to PP‐ZES, yet some benefits of use of PF‐AES in diabetic patients may prevail. Future dedicated trials should confirm these findings.