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首页> 外文期刊>Journal of endovascular therapy: an official journal of the International Society of Endovascular Specialists >Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study.
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Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study.

机译：具有无聚合物紫杉醇涂层的镍钛诺支架可治疗膝盖上方股浅和pop动脉的病变：Zilver PTX单臂临床研究的12个月安全性和有效性结果。

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PURPOSE: To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ). METHODS: The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6+/-9.5 years) were enrolled at 30 international sites. RESULTS: Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5+/-82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months. CONCLUSIONS: These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.
机译：目的：报告一项前瞻性，单臂，多中心临床研究，评估Zilver PTX药物洗脱支架治疗膝上股pop段（NCT01094678; http：//www.clinicaltrials.gov）。方法：Zilver PTX药物洗脱支架是一种自膨胀的镍钛诺支架，具有无聚合物紫杉醇涂层。膝上股pop节段有症状（从卢瑟福分类2-6）开始或再狭窄的病变（包括支架内狭窄）的患者符合入组条件。在2006年4月至2008年6月之间，在30个国际站点招募了787例患者（578名男性，平均年龄66.6 +/- 9.5岁）。结果：使用1722个Zilver PTX支架治疗了900个病变（24.3％的再狭窄病变，其中59.4％为支架狭窄）。平均病变长度为99.5 +/- 82.1 mm。 Kaplan-Meier的12个月评估包括无事件生存率89.0％，原发通畅率86.2％和无靶病变血运重建的90.5％。没有紫杉醇相关的不良反应报道。 12个月支架的骨折率为1.5％。从基线到12个月，踝臂指数，卢瑟福评分和步行距离/速度评分显着改善（p <0.001）。结论：这些结果表明，Zilver PTX药物洗脱支架对于膝上股segment段的新生和再狭窄病变的患者是安全的。在1年时，总体解剖学和临床有效性结果表明该支架是一种有前途的血管内治疗。

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