糖尿病患者中无聚合物西罗莫司洗脱支架与聚合物载紫杉醇洗脱支架随机比较的 5 年临床随访（LIPSIA Yukon 试验）。
Five-year clinical follow-up of a randomized comparison of a polymer-free sirolimus-eluting stent versus a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus (LIPSIA Yukon trial).
机构信息
Department of Internal Medicine - Cardiology, University of Leipzig - Heart Center, Leipzig, Germany.
出版信息
Catheter Cardiovasc Interv. 2014 Feb 15;83(3):418-24. doi: 10.1002/ccd.25131. Epub 2013 Aug 9.
OBJECTIVES
The long-term performance of polymer-free stent systems in patients with diabetes mellitus has not been investigated extensively. This study reports long-term results of the LIPSIA Yukon trial which compared the polymer-free sirolimus-eluting Yukon Choice stent with the polymer-based paclitaxel-eluting Taxus Liberté stent in this subpopulation. At 9 months, the Yukon Choice stent failed to show non-inferiority in terms of the primary end point late lumen loss, while no significant difference in clinical outcome was detected.
METHODS AND RESULTS
The LIPSIA Yukon trial randomized 240 patients with diabetes mellitus to a polymer-free sirolimus eluting stent (Yukon Choice, Translumina) versus a polymer-based paclitaxel-eluting stent (Taxus Liberté, Boston Scientific). Clinical follow-up was conducted with a standardized telephone follow-up and all events were centrally adjudicated. Follow-up was available for 98.3% of patients after a median of 5.0 years. The incidence of all-cause death (16.9% versus 14.0%, P = 0.67), respectively definite or presumed cardiovascular death (7.6% versus 8.8%, P = 0.94) were similar in the Yukon Choice and the Taxus Liberté group. There were no significant differences in the rates of myocardial infarction (9.3% versus 7.9%, P = 0.88), definite stent thrombosis (0.8% versus 0.9%, P = 1.0), target lesion revascularization (15.3% versus 15.8%, P = 1.0), target vessel revascularization (18.6% versus 23.7%, P = 0.44), non-target vessel revascularization (18.6% versus 26.3%, P = 0.21), and stroke (3.4% versus 4.4%, P = 0.96) between patients assigned to the Yukon Choice and the Taxus Liberté stent.
CONCLUSION
At 5 years of follow-up, clinical outcome was similar between the polymer-free sirolimus-eluting Yukon Choice stent and the polymer-based paclitaxel-eluting Taxus Liberté stent.
目的
聚合物支架在糖尿病患者中的长期疗效尚未得到广泛研究。本研究报告了 LIPSIA Yukon 试验的长期结果，该试验比较了聚合物-free 西罗莫司洗脱 Yukon Choice 支架与聚合物紫杉醇洗脱 Taxus Liberté 支架在该亚组人群中的疗效。9 个月时，Yukon Choice 支架在主要终点晚期管腔丢失方面未能显示出非劣效性，而临床结果无显著差异。
方法和结果
LIPSIA Yukon 试验将 240 例糖尿病患者随机分为聚合物-free 西罗莫司洗脱支架（Yukon Choice，Translumina）组与聚合物紫杉醇洗脱支架（Taxus Liberté，Boston Scientific）组。采用标准化电话随访进行临床随访，所有事件均由中心裁定。中位随访时间为 5.0 年后，98.3%的患者可获得随访。Yukon Choice 组和 Taxus Liberté 组的全因死亡发生率（16.9%比 14.0%，P=0.67）、明确或推测的心血管死亡发生率（7.6%比 8.8%，P=0.94）相似。心肌梗死发生率（9.3%比 7.9%，P=0.88）、明确的支架血栓形成发生率（0.8%比 0.9%，P=1.0）、靶病变血运重建率（15.3%比 15.8%，P=1.0）、靶血管血运重建率（18.6%比 23.7%，P=0.44）、非靶血管血运重建率（18.6%比 26.3%，P=0.21）和卒中发生率（3.4%比 4.4%，P=0.96）在两组之间无显著差异。
结论
在 5 年随访中，聚合物-free 西罗莫司洗脱 Yukon Choice 支架与聚合物紫杉醇洗脱 Taxus Liberté 支架的临床疗效相似。
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