Department of Medicine, Division of Cardiovascular Disease, University of California Davis Health System, Sacramento, Calif., USA.
Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.
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.
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.
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.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.
对于有症状的股浅动脉疾病患者，最佳的血管内治疗策略仍存在争议。股浅动脉支架置入术与单纯球囊血管成形术及临时支架植入术相比，其优越性和在治疗中的作用存在数据冲突。
共纳入美国和欧洲 24 个中心的 206 例有阻塞性病变的股浅动脉和腘动脉近端及间歇性跛行的患者，随机分为镍钛合金支架植入组或经皮腔内血管成形术组。支架组的平均总病变长度为 71mm，血管成形组为 64mm。支架组的急性病变成功率（<30%残余狭窄）优于血管成形组（95.8%对 83.9%；P<0.01）。血管成形组中有 29 例（40.3%）患者因血管造影结果不理想或血流受限夹层而行补救性支架置入术。最终分析时，将补救性支架置入术视为靶病变血运重建和初始通畅性丧失。12 个月时，支架组的无靶病变血运重建率为 87.3%，血管成形组为 45.1%（P<0.0001）。12 个月时，支架组的超声双功检查主要通畅率较好（81.3%对 36.7%；P<0.0001）。12 个月时，支架组有 3.1%的支架发生骨折。没有支架骨折导致通畅性丧失或靶病变血运重建。
在这项多中心试验中，对于股浅动脉和腘动脉近端的中长度病变，初次植入自膨式镍钛合金支架与单纯球囊血管成形术相比，其急性血管造影结果更好，通畅率更高。
