在当代临床实践中，与第一代药物洗脱支架相比，依维莫司洗脱 XIENCE V 支架的安全性和疗效。

Safety and efficacy of the XIENCE V everolimus-eluting stent compared to first-generation drug-eluting stents in contemporary clinical practice.

机构信息

Interventional Cardiology, Washington Hospital Center, DC, USA.

出版信息

Am J Cardiol. 2012 May 1;109(9):1288-94. doi: 10.1016/j.amjcard.2011.12.019. Epub 2012 Feb 15.

DOI:10.1016/j.amjcard.2011.12.019

PMID:22341925

Abstract

Data from randomized clinical trials have shown the safety and efficacy of the XIENCE V in selected populations. However, limited data are available comparing the XIENCE V to the first-generation CYPHER sirolimus-eluting stent. This study aimed to assess the long-term safety and clinical efficacy of the XIENCE V everolimus-eluting stent compared to first-generation stents in an unselected patient population. This retrospective analysis included 6,069 patients treated with CYPHER, TAXUS, and XIENCE stents from 2003 to 2009 at our institution. The patients were followed up for ≥1 year after the index procedure. The baseline characteristics were generally comparable among the 3 groups, with the exception of a significantly greater prevalence of diabetes mellitus, systemic hypertension, and a history of angioplasty and coronary bypass surgery among the XIENCE patients. The XIENCE patients also had a twofold greater rate of type C lesions. One-year follow-up data were available for 82% of the patients. The 1-year major adverse cardiovascular events rate was 9.3% for the XIENCE stent versus 9.8% for the CYPHER stent and 11.5% for the TAXUS stent (p = 0.11). Mortality was lower in the XIENCE group than in the CYPHER and TAXUS groups (3.6% vs 4.9% vs 7.2%, respectively, p <0.001), and target lesion revascularization was similar (5.9% vs 5.2% vs 5.6%, respectively; p = 0.34). Stent thrombosis was lower in the XIENCE patients (0.2% vs 1.2% vs 0.7%, p = 0.007). In conclusion, in a contemporary United States clinical practice with an unselected patient population, use of the XIENCE V stent was associated with an improved safety profile and reduction of all-cause mortality and stent thrombosis compared to first-generation drug-eluting stents. The XIENCE V failed to demonstrate superiority for overall major adverse cardiovascular events, Q-wave myocardial infarction, and revascularization rates.

摘要

随机临床试验的数据显示，在选定的人群中，XIENCE V 的安全性和疗效得到了证实。然而，与第一代 CYPHER 西罗莫司洗脱支架相比，比较 XIENCE V 的数据有限。本研究旨在评估 XIENCE V 依维莫司洗脱支架与第一代支架在未经选择的患者人群中的长期安全性和临床疗效。这项回顾性分析纳入了 2003 年至 2009 年在我们机构接受 CYPHER、TAXUS 和 XIENCE 支架治疗的 6069 例患者。患者在索引手术后至少随访 1 年。三组患者的基线特征基本相似，但 XIENCE 组糖尿病、系统性高血压、经皮冠状动脉成形术和冠状动脉旁路移植术的比例显著较高。XIENCE 组 C 型病变的比例也高出两倍。82%的患者可获得 1 年随访数据。XIENCE 支架的 1 年主要不良心血管事件发生率为 9.3%，CYPHER 支架为 9.8%，TAXUS 支架为 11.5%（p=0.11）。XIENCE 组的死亡率低于 CYPHER 组和 TAXUS 组（分别为 3.6%、4.9%和 7.2%，p<0.001），目标病变血运重建率相似（分别为 5.9%、5.2%和 5.6%，p=0.34）。XIENCE 患者的支架血栓形成率较低（0.2%比 1.2%比 0.7%，p=0.007）。总之，在当代美国的临床实践中，对于未经选择的患者人群，与第一代药物洗脱支架相比，使用 XIENCE V 支架可改善安全性，降低全因死亡率和支架血栓形成。XIENCE V 未能显示在总体主要不良心血管事件、Q 波心肌梗死和血运重建率方面的优越性。