San Norberto Enrique M, Fuente Ruth, Flota Cintia M, Taylor James H, Vaquero Carlos
Division of Vascular Surgery, Valladolid University Hospital, Valladolid, Spain.
Division of Vascular Surgery, Valladolid University Hospital, Valladolid, Spain.
Ann Vasc Surg. 2017 May;41:186-195. doi: 10.1016/j.avsg.2016.09.021. Epub 2017 Feb 24.
This study reports our experience during the first 50 cases of use of Supera stent for popliteal atherosclerotic lesions treatment.
This prospective single-arm trial enrolled the first 50 limbs (46 patients) treated in our center with a Supera stent for symptomatic atherosclerotic disease of the popliteal artery and a follow-up longer than 12 months.
Tissue loss (43.5%) was the most common primary indication for intervention, followed by claudication (37.0%) and rest pain (19.5%). Stent implantation was successful in all patients. The majority of lesions were Trans-Atlantic Inter-Society Consensus (TASC) II type D lesions (64%). The lesions treated were localized in P3 zone in 64%, P2 zone in 28%, and P1 zone in 8%. One runoff vessel was the most common situation (42%). Mean follow-up was 16.5 months (range 12-46). The mean preoperative ankle-brachial index increased from 0.38 + 0.37 before intervention to 0.63 + 0.86 postoperatively at 12 months (P = 0.014). Primary patency rates at 3, 6, 9, and 12 months were 95.9%, 91.7%, 89.6%, and 89.6%, and primary assisted patency rates were 95.9%, 93.8%, 93.8%, and 93.8%, respectively. In-stent restenosis was associated with the following: patient <75 years (P = 0.023), female sex (P = 0.032), and TASC-II D lesions (P = 0.041). Implantation defects did not constitute a risk factor for stent restenosis.
The implantation of the interwoven nitinol stents in patients with popliteal occlusive disease is safe and effective, with encouraging patency rates and clinical results after a 12-month follow-up. In our experience, we have not seen significant differences in patency at 1-year follow-up in patients with implantation defects.
本研究报告了我们在使用Supera支架治疗腘动脉粥样硬化病变的前50例病例中的经验。
这项前瞻性单臂试验纳入了我们中心首批接受Supera支架治疗的50条肢体（46例患者），这些患者患有症状性腘动脉粥样硬化疾病，且随访时间超过12个月。
组织缺失（43.5%）是最常见的主要干预指征，其次是间歇性跛行（37.0%）和静息痛（19.5%）。所有患者支架植入均成功。大多数病变为跨大西洋两岸血管外科学会（TASC）II型D病变（64%）。治疗的病变位于P3区的占64%，P2区的占28%，P1区的占8%。单支流出道血管是最常见的情况（42%）。平均随访时间为16.5个月（范围12 - 46个月）。术前平均踝肱指数从干预前的0.38±0.37增加到术后12个月时的0.63±0.86（P = 0.014）。3、6、9和12个月时的主要通畅率分别为95.9%、91.7%、89.6%和89.6%，主要辅助通畅率分别为95.9%、93.8%、93.8%和93.8%。支架内再狭窄与以下因素相关：年龄<75岁（P = 0.023）、女性（P = 0.032）和TASC-II D病变（P = 0.041）。植入缺陷不是支架再狭窄的危险因素。
在腘动脉闭塞性疾病患者中植入编织镍钛合金支架是安全有效的，12个月随访后通畅率和临床结果令人鼓舞。根据我们的经验，在有植入缺陷的患者中，1年随访时的通畅率未见显著差异。
