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Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

机译:Everolimus洗脱支架,适用于患有临伤肢体缺血和InfrapopliNeal动脉闭塞疾病的患者

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Background: Critical limb ischemia (CLI), despite revascularization, may result in minor or major amputations with devastating psychological effects and a negative impact on patient survival. Randomized clinical trials demonstrated that drug-eluting stents improve 1-year primary patency and decrease target lesion revascularization, compared to standard angioplasty and bare-metal stents, in patients with short occlusive below-the-knee lesions. Objectives: This prospective clinical study was designed to evaluate if one straight-line flow revascularization to the foot, using Xience-Prime Everolimus-Eluting Stent (EES), is an effective treatment of patients in Rutherford-Becker category 4 to 5 with distal popliteal and proximal tibial arteries long occlusive lesions up to 10 cm. Methods: All patients with angiographic documented segment P3 of popliteal artery and proximal tibial arteries stenosis > 70%, and lesion length between 20 mm and 100 mm, meeting the inclusion criteria, were included in the Etna Registry. The end points assessed were 1-and 3-year primary patency, major amputation-free survival, target lesion revascularization, and wound healing rates. Results: Between June 2011 and April 2014, 122 patients were included in the study, with mean lesion length of 52.7 mm (range: 20-100 mm). The 1-and 3-year primary patency rates were 88.9% and 80.1%, respectively. The survival, major amputation-free survival, and target lesion revascularization rates were 88.1%, 93%, and 91.5% at 1-year and 70.4%, 89.3%, and 85.1% at 3-year follow-up, respectively. Primary patency influenced major amputation rate, which was 60% in patients with no target artery patency versus 5.4% in patients with patency (P =.022). At 1-year follow-up, 78 (88.6%) of 88 patients improved 1 or more of their Rutherford-Becker category, and 48 (80%) of 69 patients had wound healing. Conclusions: The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.
机译:背景:临界肢体缺血(CLI)尽管血运重建,可能导致患有毁灭性心理效应和对患者存活的负面影响的轻微或主要截肢。随机临床试验表明,与标准血管成形术和裸金属支架相比,药物洗脱支架提高了1年的初级通用和减少目标病变血运重建,膝关节短暂的闭塞病变。目的:这种前瞻性临床研究旨在评估一种直接流动血运重建于脚的直线流动血管,使用傲慢性血管植物洗脱支架(EES)是有效的曲氏患者患者的患者,远端popliteal近端胫骨动脉长达10厘米的闭塞病变。方法:在ETNA登记处,迄今为止,所有患有Popliteal动脉和近端胫骨动脉和近端胫骨动脉狭窄的血管造影细胞狭窄狭窄> 70%的患者,以及20mm和100毫米的病变长度,都包含在ETNA登记中。评估的终点是1至3年的主要通畅,主要截肢生存,目标病变血运重建和伤口愈合率。结果:2011年6月至2014年4月期间,研究中包含122名患者,平均病变长度为52.7毫米(范围:20-100毫米)。 1至3年的主要通用率分别为88.9%和80.1%。生存率,主要截肢生存期和目标病变血运重建率分别为88.1%,93%和91.5%,分别为3年后的70.4%,89.3%和85.1%。初级通畅影响了主要的截肢率,患者对患者的患者的患者患者有60%(P = .022)。在1年的后续随访中,78名(88.6%)的88名患者改善了卢瑟福 - Becker类别的1或更多,48名(80%)的69例患者患有伤口愈合。结论:我们的研究结果表明,在CLI和IncapopliNeTeal动脉闭塞病患者中,具有EES的保守方法似乎是可行的。

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