Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium.
J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.
Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision).
A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of ≥50% restenosis based on quantitative analysis of contrast angiography.
Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P = .0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P < .0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P = .001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P = .001).
Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents.
严重肢体缺血是外周动脉疾病的最严重形式，如果不进行治疗，最终会导致截肢。最近，腔内开通狭窄或闭塞的腘下动脉已经成为一种有效的治疗方法，尽管再狭窄通常会限制其通畅时间。最近，人们提出最初为冠状动脉开发的药物洗脱支架也可能有效预防腘下动脉再狭窄。本前瞻性、随机、对照临床试验旨在检验这样一个假设，即使用依维莫司洗脱支架（Xience V）治疗腘下动脉闭塞性病变，与使用裸金属支架（Multi-Link Vision）相比，能够提供更好的通畅率。
计划在欧洲的五个研究点招募 140 名患者。主要终点是 12 个月时的动脉通畅率，定义为定量造影分析显示无 ≥50%再狭窄。
2008 年 3 月至 2009 年 9 月，74 名患者接受 Xience V 治疗，66 名患者接受 Vision 治疗。12 个月后，Xience V 治疗后的主要通畅率为 85%，而 Vision 治疗后的为 54%（P =.0001）。Xience V 治疗显著降低了支架内平均直径狭窄（21%±21% vs 47%±27%；P<.0001）和支架内平均晚期管腔丢失（0.78±0.63 vs 1.41±0.89 mm；P =.001）。12 个月随访时，接受 Rutherford 分级 0 或 1 的患者比例在两组之间无差异（Vision 组为 56%，Xience V 组为 60%；P =.68）。两组的主要肢体截肢都很少见（Vision 组 2 例，Xience V 组 1 例）。使用 Xience V 支架可显著减少再次介入治疗的需要：Xience V 组无靶病变血运重建的比例为 91%，而 Vision 组为 66%（P =.001）。
与裸金属支架相比，使用依维莫司洗脱支架治疗严重肢体缺血的腘下动脉闭塞性病变可降低再狭窄率和再次介入治疗的需要。
