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首页> 外文期刊>Circulation. Cardiovascular interventions >Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial.
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Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial.

机译：镍钛合金支架植入术与球囊血管成形术治疗股浅表动脉和pop部近端动脉病变：RESILIENT随机试验的12个月结果。

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BACKGROUND: Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation. METHODS AND RESULTS: A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of nitinol stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization. CONCLUSIONS: In this multicenter trial, primary implantation of a self-expanding nitinol stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.
机译：背景：关于股浅表症状性疾病患者的最佳血管内治疗策略仍存在争议。关于与股动脉临时支架植入术相比，浅表股动脉支架置入术的益处以及股动脉支架置入术的作用存在矛盾的数据。方法和结果：来自美国和欧洲24个中心的206例股浅表动脉和proximal部近端梗阻性病变并间歇性c行的患者被随机分配为镍钛合金支架植入或经皮腔内血管成形术。支架组的平均总病变长度为71 mm，血管成形术组的平均总病变长度为64 mm。支架组的急性病变成功率（<30％残余狭窄）优于血管成形术组（95.8％对83.9％; P <0.01）。血管成形术组中有29例（40.3％）患者因血管造影结果欠佳或流量受限解剖而接受了支架置入术。在最终分析中，将救助支架置为目标病变血运重建和主要通畅性丧失。在12个月时，支架组的靶病变血运重建率为87.3％，而血管成形术组为45.1％（P <0.0001）。支架组在12个月时双超声源性原发通畅性更好（81.3％比36.7％; P <0.0001）。在12个月内，植入的支架中有3.1％发生了骨折。没有支架骨折导致通畅性丧失或靶病变血运重建。结论：在该多中心试验中，与单独的球囊血管成形术相比，对于股浅表动脉和ol部近端动脉中度病变的自体扩张镍钛合金支架的初次植入与更好的急性血管造影结果和通畅性相关。临床试验注册：URL：http://www.clinicaltrials.gov。唯一标识符：NCT00673985。

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