Marmagkiolis Konstantinos, Hakeem Abdul, Choksi Nishit, Al-Hawwas Malek, Edupuganti Mohan Mallikarjuna Rao, Leesar Massoud A, Cilingiroglu Mehmet
Citizens Memorial Hospital Heart and Vascular Institute, Bolivar, Missouri.
Catheter Cardiovasc Interv. 2014 Oct 1;84(4):555-64. doi: 10.1002/ccd.25510. Epub 2014 May 8.
Endovascular approach to superficial femoral artery (SFA) disease, the most common cause of symptomatic peripheral arterial disease, remains fraught with high failure rates. Newer devices including second-generation nitinol stents, drug-coated stents, drug-coated balloons, covered stents, cryo-therapy, LASER, and directional atherectomy have shown promising results. Clinical equipoise still persists regarding the optimal selection of devices, largely attributable to the different inclusion criteria, study population, length of lesions treated, definition of "patency" and "restenosis," and follow-up methods in the pivotal trials.
A prospective protocol was developed. We performed a literature search using PubMed from January 2006 to November 2013. Published articles including endovascular interventions in SFA or popliteal arteries with reported 12-month "primary patency" or "binary restenosis" rates as endpoints were included.
We identified 6,024 patients in 61 trials reporting 12-month primary patency rates in patients with femoropoliteal disease. Primary patency rates were (weighted average) 77.2% for nitinol stents, 68.8% for covered stents, 84% for drug eluting stents, 78.2% for drug eluting/coated balloon, 60.7% for cryoballoon, 51.1% for LASER atherectomy, 63.5% for directional atherectomy and 70.2% with a combination of endovascular devices.
The most frequently used endovascular devices yielded various 12-month primary patency rates ranging from 51% to 85%. The increased variation in inclusion criteria, length, and complexity of lesions between studies does not allow direct comparison between them. Larger randomized trials in specific patient populations comparing those modalities is needed before we can make safe recommendation of the superiority of one device over the other.
股浅动脉（SFA）疾病是有症状的外周动脉疾病最常见的病因，血管内治疗方法的失败率仍然很高。包括第二代镍钛合金支架、药物涂层支架、药物涂层球囊、覆膜支架、冷冻治疗、激光和定向斑块旋切术在内的新型器械已显示出有前景的结果。关于器械的最佳选择，临床 equipoise 仍然存在，这在很大程度上归因于关键试验中不同的纳入标准、研究人群、治疗病变的长度、“通畅”和“再狭窄”的定义以及随访方法。
制定了一项前瞻性方案。我们使用 PubMed 对2006年1月至2013年11月的文献进行了检索。纳入已发表的文章，这些文章将股腘动脉血管内干预且报告12个月“主要通畅率”或“二元再狭窄率”作为终点。
我们在61项试验中确定了6024例患者，这些试验报告了股腘疾病患者的12个月主要通畅率。镍钛合金支架的主要通畅率（加权平均）为77.2%，覆膜支架为68.8%，药物洗脱支架为84%，药物洗脱/涂层球囊为为78.2%，冷冻球囊为60.7%，激光斑块旋切术为51.1%，定向斑块旋切术为63.5%，血管内器械联合使用为70.2%。
最常用的血管内器械产生了51%至85%不等的12个月主要通畅率。研究之间纳入标准、病变长度和复杂性的差异增加，不允许对它们进行直接比较。在我们能够安全推荐一种器械优于另一种器械之前，需要在特定患者群体中进行更大规模的随机试验来比较这些方法。
