Abstract
Background Extended long-term follow-up data of new-generation drug-eluting stents in patients with diabetes mellitus is scant. The aim of this study is to assess the 10-year clinical outcome of new-generation biodegradable polymer-based sirolimus-eluting stents (Yukon Choice PC) versus permanent polymer-based everolimus-eluting stents (XIENCE) in patients with and without diabetes mellitus. Methods and Results In a prespecified subgroup analysis, outcomes of patients with or without diabetes mellitus treated with drug-eluting stents were compared. The primary end point of this analysis was major adverse cardiac event, the composite of death, myocardial infarction, or target lesion revascularization. The analysis includes a total of 1951 patients (560 patients with and 1391 patients without diabetes mellitus) randomized to treatment with Yukon Choice PC (n=1299) or Xience (n=652). Regarding the primary end point, at 10 years patients with diabetes mellitus showed significantly higher major adverse cardiac event rates than patients without diabetes mellitus (P<0.001; hazard ratio [HR], 1.41; 95% CI, 1.22-1.63). There was no significant difference between patients treated with Yukon Choice PC versus Xience, neither in the subgroup of patients with (P=0.91; HR, 1.01; 95% CI, 0.79-1.30) nor without diabetes mellitus (P=0.50; HR, 0.94; 95% CI, 0.79-1.21). Rates of definite/probable stent thrombosis were 2.3% in patients with and 1.9% in patients without diabetes mellitus (HR, 1.27; 95% CI, 0.34-2.60; P=0.52), without significant differences between study devices. Conclusions The clinical outcome of patients with diabetes after percutaneous coronary intervention with different new-generation drug-eluting stents is considerably worse than that of patients without diabetes mellitus, with event rates constantly increasing out to 10 years. Registration URL: https://clinicaltrials.gov. Unique Identifier: NCT00598676.