Deutsches Herzzentrum Muenchen an der Technische Universität Muenchen Klinik für Herz- und Kreislauferkrankungen Munich Germany.
DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance Munich Germany.
J Am Heart Assoc. 2021 Jun 15;10(12):e020165. doi: 10.1161/JAHA.120.020165. Epub 2021 Jun 2.
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 (<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 (=0.91; HR, 1.01; 95% CI, 0.79-1.30) nor without diabetes mellitus (=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; =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.
背景 ：关于新型药物洗脱支架在糖尿病患者中的长期随访数据较为匮乏。本研究旨在评估新一代可生物降解聚合物西罗莫司洗脱支架（Yukon Choice PC）与永久性聚合物依维莫司洗脱支架（XIENCE）在糖尿病和非糖尿病患者中的 10 年临床结果。
方法和结果 ：在预设的亚组分析中，比较了药物洗脱支架治疗的糖尿病和非糖尿病患者的结局。本分析的主要终点为主要不良心脏事件，即死亡、心肌梗死或靶病变血运重建的复合终点。该分析共纳入 1951 例患者（560 例糖尿病患者和 1391 例非糖尿病患者），随机接受 Yukon Choice PC（n=1299）或 Xience 治疗（n=652）。主要终点方面，10 年时糖尿病患者的主要不良心脏事件发生率显著高于非糖尿病患者（<0.001；风险比[HR]，1.41；95%可信区间[CI]，1.22-1.63）。在糖尿病患者中（=0.91；HR，1.01；95% CI，0.79-1.30）和非糖尿病患者中（=0.50；HR，0.94；95% CI，0.79-1.21），Yukon Choice PC 与 Xience 之间的主要不良心脏事件发生率无显著差异。糖尿病患者的支架血栓形成明确/可能发生率为 2.3%，非糖尿病患者为 1.9%（HR，1.27；95% CI，0.34-2.60；=0.52），两种研究器械之间无显著差异。
结论 ：经皮冠状动脉介入治疗中不同新型药物洗脱支架治疗的糖尿病患者临床结局显著差于非糖尿病患者，且在 10 年内事件发生率持续增加。
NCT00598676。
