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新型薄支架TAXUS Liberté支架降低小血管再狭窄风险及长病变心肌梗死风险:TAXUS ATLAS项目1年结果

Reduced risk of restenosis in small vessels and reduced risk of myocardial infarction in long lesions with the new thin-strut TAXUS Liberté stent: 1-year results from the TAXUS ATLAS program.

作者信息

Turco Mark A, Ormiston John A, Popma Jeffrey J, Hall Jack J, Mann Tift, Cannon Louis A, Webster Mark W I, Mishkel Gregory J, O'Shaughnessy Charles D, McGarry Thomas F, Mandinov Lazar, Dawkins Keith D, Baim Donald S

机构信息

Center for Cardiac & Vascular Research, Washington Adventist Hospital, Takoma Park, Maryland 20912, USA.

出版信息

JACC Cardiovasc Interv. 2008 Dec;1(6):699-709. doi: 10.1016/j.jcin.2008.09.007.

DOI:10.1016/j.jcin.2008.09.007
PMID:19463387
Abstract

OBJECTIVES

The TAXUS ATLAS Small Vessel (SV) and Long Lesion (LL) multicenter studies compared the performance of the thin-strut (0.0038 inch) TAXUS Liberté 2.25-mm stent (Boston Scientific; Natick, Massachusetts) and the TAXUS Liberté 38-mm long stent (Boston Scientific; Natick, Massachusetts) with the earlier paclitaxel-eluting TAXUS Express (Boston Scientific) stent that has identical polymer, drug dosage, and release kinetics but different stent geometry and thicker struts (0.0052 inch).

BACKGROUND

The TAXUS Liberté stent was designed with thinner and more even strut spacing to provide more uniform drug distribution, as well as increased flexibility and conformability. Clinical benefits of the new stent design have not been evaluated.

METHODS

The TAXUS ATLAS SV and LL studies are nonrandomized studies comparing outcomes of the TAXUS Liberté 2.25 mm (N = 261) and TAXUS Liberté 38 mm (N = 150) stents to TAXUS Express historical control groups derived from the TAXUS IV and V trials. Inclusion/exclusion criteria for TAXUS Express and Liberté groups were similar in both studies.

RESULTS

Each study met its primary end point of noninferiority of 9-month in-segment diameter stenosis. Furthermore, TAXUS Liberté 2.25 mm, when compared with TAXUS Express, significantly reduced the rate of both 9-month angiographic restenosis (18.5% vs. 32.7%, p = 0.0219) and 12-month target lesion revascularization (6.1% vs. 16.9%, p = 0.0039). In addition, TAXUS Liberté 38 mm significantly reduced the risk of 12-month myocardial infarction compared with TAXUS Express (1.4% vs. 6.5%, p = 0.0246).

CONCLUSIONS

The thinner-strut TAXUS Liberté stent improved outcomes compared with the earlier TAXUS Express stent in both SVs and LLs (A Study of the TAXUS Liberté Stent for the Treatment of de Novo Coronary Artery Lesions in Small Vessels; NCT00371748; A Study of the TAXUS Liberté Stent for the Treatment of Long De Novo Coronary Artery Lesions; NCT00371475).

摘要

目的

TAXUS ATLAS小血管(SV)和长病变(LL)多中心研究比较了薄支柱(0.0038英寸)的TAXUS Liberté 2.25毫米支架(波士顿科学公司;马萨诸塞州纳蒂克)和TAXUS Liberté 38毫米长支架(波士顿科学公司;马萨诸塞州纳蒂克)与早期紫杉醇洗脱TAXUS Express(波士顿科学公司)支架的性能,二者具有相同的聚合物、药物剂量和释放动力学,但支架几何形状不同且支柱更厚(0.0052英寸)。

背景

TAXUS Liberté支架设计有更薄且间距更均匀的支柱,以提供更均匀的药物分布,以及更高的柔韧性和顺应性。这种新支架设计的临床益处尚未得到评估。

方法

TAXUS ATLAS SV和LL研究为非随机研究,比较TAXUS Liberté 2.25毫米(N = 261)和TAXUS Liberté 38毫米(N = 150)支架与来自TAXUS IV和V试验的TAXUS Express历史对照组的结果。TAXUS Express组和Liberté组的纳入/排除标准在两项研究中相似。

结果

每项研究均达到其9个月节段内直径狭窄非劣效性的主要终点。此外,与TAXUS Express相比,TAXUS Liberté 2.25毫米显著降低了9个月血管造影再狭窄率(18.5%对32.7%,p = 0.0219)和12个月靶病变血运重建率(6.1%对16.9%,p = 0.0039)。此外,与TAXUS Express相比,TAXUS Liberté 38毫米显著降低了12个月心肌梗死风险(1.4%对6.5%,p = 0.0246)。

结论

与早期TAXUS Express支架相比,薄支柱TAXUS Liberté支架在小血管和长病变中均改善了治疗结果(TAXUS Liberté支架治疗小血管原发性冠状动脉病变的研究;NCT00371748;TAXUS Liberté支架治疗长原发性冠状动脉病变的研究;NCT00371475)。

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