Center for Vascular Medicine, Angiology, and Vascular Surgery, Park Hospital Leipzig, Germany.
J Endovasc Ther. 2011 Dec;18(6):745-52. doi: 10.1583/11-3500.1.
To examine the efficacy and integrity of a novel interwoven self-expanding nitinol stent system for the treatment of complex femoropopliteal lesions in a "real world" medical practice.
This retrospective analysis included 107 consecutive patients (77 men; mean age 68.9 years) with atherosclerotic femoropopliteal lesions (occlusions in 31%) who underwent implantation of 137 SUPERA stents. The patients were followed for up to 24 months by Doppler ultrasound examinations, radiography of the stent, and assessments of Rutherford-Becker class and ankle-brachial index (ABI).
The mean implanted stent length was 111±50 mm (range 40-270). Procedure success (residual stenosis <30%) was achieved in 99% of procedures. The 6-, 12-, and 24-month cumulative primary patency rates (± standard error) were 93.1%±2.5%, 84.7%±3.6%, and 76.1%±4.5%, respectively, and the secondary patency rates were 99.0%±0.1%, 94.8%±0.2% and 91.9%±0.3%, respectively. Between baseline and 24 months, mean ABI increased from 0.68±0.14 to 0.87±0.10 and the mean Rutherford-Becker class decreased from 3.3±0.7 to 2.0±1.0 (p<0.0001 for both). Radiographs performed in 91 patients at a mean of 16.8±7.0 months found no stent fractures.
Over a 2-year surveillance period, excellent durability without stent fractures was documented after implantation of the SUPERA stent in complex femoropopliteal lesions. In addition, significant improvements were observed in symptom classification and hemodynamics.
在真实医疗实践中，检验一种新型编织自膨式镍钛诺支架系统治疗复杂股腘动脉病变的疗效和完整性。
本回顾性分析纳入了 107 例连续的股腘动脉粥样硬化性病变患者（31%为闭塞病变），共植入 137 枚 SUPERA 支架。患者接受了长达 24 个月的多普勒超声检查、支架影像学检查以及 Rutherford-Becker 分级和踝肱指数（ABI）评估。
平均植入支架长度为 111±50mm（范围 40-270mm）。99%的手术实现了技术上的成功（残余狭窄<30%）。6、12 和 24 个月的累积一期通畅率（±标准误差）分别为 93.1%±2.5%、84.7%±3.6%和 76.1%±4.5%，二期通畅率分别为 99.0%±0.1%、94.8%±0.2%和 91.9%±0.3%。与基线相比，24 个月时平均 ABI 从 0.68±0.14 增加到 0.87±0.10，平均 Rutherford-Becker 分级从 3.3±0.7 降低到 2.0±1.0（均<0.0001）。在 91 例患者中，于平均 16.8±7.0 个月进行的 X 线片检查未发现支架断裂。
在长达 2 年的随访期间，在复杂股腘动脉病变中植入 SUPERA 支架后，证实了其具有良好的耐久性，无支架断裂。此外，症状分类和血液动力学均有显著改善。
