Department of Vascular Surgery, Algemeen Ziekenhuis Sint-Blasius, Dendermonde, Belgium.
J Vasc Surg. 2011 Oct;54(4):1042-50. doi: 10.1016/j.jvs.2011.03.272. Epub 2011 Jun 2.
This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length.
Between March 2008 and June 2009, 100 patients (66 men) presenting with 100 symptomatic TASC C and D femoropopliteal lesions were treated with at least one 200-mm-long Protégé EverFlex stent. The intention of this study was to treat all lesions with as few stents as possible. The primary study end point was primary patency at 12 months, defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target lesion and without target lesion revascularization (TLR) ≤12 months. Stent fracture occurrence was assessed at the 12-month follow-up by conventional x-ray imaging.
Average patient age was 70 years. Preoperative symptom assessment reported 71 patients (71%) had claudication vs 29 (29%) with critical limb ischemia. Average lesion length was 242 mm (range, 160-450 mm), and 27 patients (27%) presented with popliteal involvement. A total of 158 Protégé EverFlex stents were used to treat 100 lesions. Kaplan-Meier estimation reported a 12-month freedom from target lesion revascularization of 68.2% and a primary patency rate of 64.8%. Stent fractures occurred in six patients (6.0%) when x-ray images taken immediately after the procedure were compared with those taken after 1 year.
The results of our Durability-200 study show an acceptable primary patency rate after 1 year was obtained in this patient cohort with TASC C and D femoropopliteal lesions.
本研究旨在探讨 Protégé EverFlex 200mm 长自膨式镍钛诺支架（ev3 Endovascular Inc，明尼苏达州普利茅斯）在 TASC C 和 D 级至少 150mm 长股腘动脉病变中的初始通畅率。
2008 年 3 月至 2009 年 6 月，100 例（66 例男性）患有 TASC C 和 D 级股腘动脉症状性病变的患者接受了至少一个 200mm 长的 Protégé EverFlex 支架治疗。本研究的目的是用尽可能少的支架治疗所有病变。主要研究终点是 12 个月时的初始通畅率，定义为目标病变处双功能超声成像（收缩期速度比<2.4）无血流动力学显著狭窄，且 12 个月内无目标病变血运重建（TLR）。支架断裂发生情况在 12 个月时通过常规 X 射线成像评估。
平均患者年龄为 70 岁。术前症状评估显示，71 例（71%）患者有跛行，29 例（29%）有严重肢体缺血。平均病变长度为 242mm（范围 160-450mm），27 例（27%）患者有腘动脉受累。共使用 158 个 Protégé EverFlex 支架治疗 100 个病变。Kaplan-Meier 估计报告 12 个月时无 TLR 率为 68.2%，初始通畅率为 64.8%。与术后 1 年的 X 射线图像相比，6 例（6.0%）患者即刻 X 射线图像显示支架出现断裂。
我们的 Durability-200 研究结果表明，在 TASC C 和 D 级股腘动脉病变患者中，1 年后获得了可接受的初始通畅率。
