Institute of Clinical Radiology and Nuclear Medicine, University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
J Vasc Interv Radiol. 2012 Oct;23(10):1317-22. doi: 10.1016/j.jvir.2012.05.045. Epub 2012 Jul 26.
To evaluate the clinical efficacy of EverFlex stents (length, 6-20 cm) for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).
Over a period of 18 months, 56 SFA lesions in 53 patients were treated with an EverFlex stent. The following parameters were documented before the intervention, immediately afterward, and 12 months later: clinical stage, ankle-brachial index, and peak systolic velocity ratio (PSVR). The primary study endpoint was the primary patency rate after 12 months (defined as a PSVR < 2.5).
In 18% of the 56 lesions, complete occlusions were present. Mean lesion length was 9.4 cm ± 5.3, and mean stent length was 12.6 cm ± 5.6. Of the 53 patients enrolled in the study, a 12-month follow-up was performed in 46. The primary patency rate after 12 months was 71.7%. In-stent restenosis or occlusion occurred in 13 patients. Compared with the total study group, the mean stent length in these 13 patients was greater (14.0 cm ± 7.3) and the incidence of de novo lesions was lower. In the patient group with stents less than 10 cm in length (n = 24), six patients (25%) required a repeat intervention, compared with seven patients (32%) in the group with stents longer than 12 cm.
Although the primary patency rate associated with the EverFlex stent is comparable to those in published data, the present results demonstrate a higher percentage of in-stent stenoses in patients in whom longer SFA stents were implanted.
评估 EverFlex 支架（长度 6-20cm）治疗股浅动脉（SFA）周围动脉疾病（PAD）的临床疗效。
在 18 个月的时间内，53 名患者的 56 处 SFA 病变接受了 EverFlex 支架治疗。在干预前、干预后即刻和 12 个月后记录以下参数：临床分期、踝肱指数和峰值收缩速度比（PSVR）。主要研究终点为 12 个月后的主要通畅率（定义为 PSVR<2.5）。
在 56 处病变中，有 18%为完全闭塞。平均病变长度为 9.4cm±5.3cm，平均支架长度为 12.6cm±5.6cm。在入组的 53 名患者中，46 名患者完成了 12 个月的随访。12 个月后的主要通畅率为 71.7%。13 名患者发生支架内再狭窄或闭塞。与总研究组相比，这 13 名患者的平均支架长度更大（14.0cm±7.3cm），新发病变的发生率更低。在支架长度小于 10cm 的患者组（n=24）中，有 6 名患者（25%）需要再次介入治疗，而支架长度大于 12cm 的患者组中有 7 名患者（32%）需要再次介入治疗。
尽管 EverFlex 支架的主要通畅率与已发表的数据相当，但本研究结果表明，在植入较长的 SFA 支架的患者中，支架内狭窄的比例更高。
