Calloon angioplasty versus implantation of nitinol stents in the superficial femoral artery
Calloon angioplasty versus implantation of nitinol stents in the superficial femoral artery
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DOI：
10.1056/nejmoa051303
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发表时间：
2006-05-04
影响因子：
158.5
通讯作者：
Minar, E
中科院分区：
文献类型：
--
作者：
Schillinger, M;Sabeti, S;Minar, E
背景：由于股浅动脉疾病的支架植入术与晚期临床失败率高相关，因此经皮腔内血管成形术是血管内治疗的首选方法，仅在技术结果欠佳的情况下推荐支架植入术。我们评估了自膨式镍钛合金（镍钛合金）支架的初次植入是否产生了解剖学和临床效益上级的经皮腔内血管成形术与可选的二级stenting.METHODS：我们随机分配104例严重跛行或慢性肢体缺血，由于狭窄或闭塞的股浅动脉进行初次支架植入术（51例）或血管成形术（53例）。在6个月和12个月时评估恢复和临床结果。结果：支架组治疗段的平均（+/-SD）长度为132+/-71 mm，血管成形术组为127+/-55 mm。在血管成形术组的53名患者中，有17名（32%）进行了二次支架植入术，大多数情况下是因为血管成形术后的次优结果。6个月时，血管造影显示支架组和血管成形术组的再狭窄率分别为24%和43%（P=0.05）; 12个月时，双功超声检查显示支架组和血管成形术组的再狭窄率分别为37%和63%（P=0.01）。支架组患者在6个月和12个月时，在跑步机上行走的距离比血管成形术组的患者明显更远。结论：在中期内，自膨式镍钛合金支架初次植入治疗股浅动脉疾病的结果上级目前推荐的球囊血管成形术与可选的二次支架植入方法。
BACKGROUND:Because stent implantation for disease of the superficial femoral artery has been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is preferred for endovascular treatment, and stenting is recommended only in the event of suboptimal technical results. We evaluated whether primary implantation of a self-expanding nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.METHODS:We randomly assigned 104 patients who had severe claudication or chronic limb ischemia due to stenosis or occlusion of the superficial femoral artery to undergo primary stent implantation (51 patients) or angioplasty (53 patients). Restenosis and clinical outcomes were assessed at 6 and 12 months.RESULTS:The mean (+/-SD) length of the treated segment was 132+/-71 mm in the stent group and 127+/-55 mm in the angioplasty group. Secondary stenting was performed in 17 of 53 patients (32 percent) in the angioplasty group, in most cases because of a suboptimal result after angioplasty. At 6 months, the rate of restenosis on angiography was 24 percent in the stent group and 43 percent in the angioplasty group (P=0.05); at 12 months the rates on duplex ultrasonography were 37 percent and 63 percent, respectively (P=0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group.CONCLUSIONS:In the intermediate term, treatment of superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting.