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用于经皮冠状动脉介入治疗中在小冠状动脉内使用的新型支架设计。

New stent design for use in small coronary arteries during percutaneous coronary intervention.

作者信息

Granada Juan F, Huibregtse Barbara A, Dawkins Keith D

机构信息

The Jack H Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, Columbia University Medical Center, New York, NY, USA.

出版信息

Med Devices (Auckl). 2010;3:57-66. doi: 10.2147/MDER.S13494. Epub 2010 Oct 19.

Abstract

Patients with diabetes mellitus, of female gender, increased age, and/or with peripheral vascular disease often develop coronary stenoses in small caliber vessels. This review describes treatment of these lesions with the paclitaxel-eluting 2.25 mm TAXUS(®) Liberté(®) Atom™ stent. Given the same stent composition, polymer, antirestenotic drug (paclitaxel), and release kinetics as the first-generation 2.25 mm TAXUS(®) Express(®) Atom™ stent, the second-generation TAXUS Liberté Atom stent incorporates improved stent design characteristics, including thinner struts (0.0038 versus 0.0052 inches), intended to increase conformability and deliverability. In a porcine noninjured coronary artery model, TAXUS Liberté Atom stent implantation in small vessels demonstrated complete strut tissue coverage compared with the bare metal stent control, suggesting a similar degree of tissue healing between the groups at 30, 90, and 180 days. The prospective, single-armed TAXUS ATLAS Small Vessel trial demonstrated improved instent late loss (0.28 ± 0.45 versus 0.84 ± 0.57 mm, P < 0.001), instent binary restenosis (13.0% versus 38.1%, P < 0.001), and target lesion revascularization (5.8% versus 17.6%, P < 0.001) at nine months with the TAXUS Liberté Atom stent as compared with the bare metal Express stent control, with similar safety measures between the two groups. The TAXUS Liberté Atom also significantly reduced nine-month angiographic rates of both instent late loss (0.28 ± 0.45 versus 0.44 ± 0.61 mm, P = 0.03) and instent binary restenosis (13.0% versus 25.9%, P = 0.02) when compared with the 2.25 mm TAXUS Express Atom control. The observed reduction in target lesion revascularization with the TAXUS Liberté Atom compared with the TAXUS Express Atom at nine months (5.8% versus 13.7%, P = 0.02) was sustained through three years (10.0% versus 22.1%, P = 0.008) with similar, stable safety outcomes between the groups. In conclusion, these data confirm the safety and favorable performance of the TAXUS Liberté Atom stent in the treatment of small coronary vessels.

摘要

患有糖尿病、女性、年龄较大和/或患有外周血管疾病的患者,常出现小口径血管的冠状动脉狭窄。本综述描述了使用紫杉醇洗脱2.25毫米TAXUS(®) Liberté(®) Atom™支架治疗这些病变的情况。与第一代2.25毫米TAXUS(®) Express(®) Atom™支架具有相同的支架成分、聚合物、抗再狭窄药物(紫杉醇)和释放动力学,第二代TAXUS Liberté Atom支架具有改进的支架设计特点,包括更薄的支架小梁(0.0038英寸对0.0052英寸),旨在提高顺应性和可输送性。在猪非损伤冠状动脉模型中,与裸金属支架对照相比,在小血管中植入TAXUS Liberté Atom支架显示支架小梁完全被组织覆盖,表明两组在30、90和180天时组织愈合程度相似。前瞻性单臂TAXUS ATLAS小血管试验表明,与裸金属Express支架对照相比,使用TAXUS Liberté Atom支架在9个月时支架内晚期管腔丢失有所改善(0.28±0.45对0.84±0.57毫米,P<0.001)、支架内二元再狭窄有所改善(13.0%对38.1%,P<0.001)以及靶病变血运重建有所改善(5.8%对17.6%,P<0.001),两组间安全指标相似。与2.25毫米TAXUS Express Atom对照相比,TAXUS Liberté Atom还显著降低了9个月时支架内晚期管腔丢失(0.28±0.45对0.44±0.61毫米,P = 0.03)和支架内二元再狭窄(13.0%对25.9%,P = 0.02)的血管造影率。与TAXUS Express Atom相比,TAXUS Liberté Atom在9个月时观察到的靶病变血运重建减少(5.8%对13.7%,P = 0.02)在3年时仍持续存在(10.0%对22.1%,P = 0.008),两组间安全结果相似且稳定。总之,这些数据证实了TAXUS Liberté Atom支架在治疗小冠状动脉血管方面的安全性和良好性能。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a32c/3417866/dce02db8636d/mder-3-057f1.jpg

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