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SUPERA支架在膝上介入治疗中的效果:压缩与拉伸的影响(SAKE-COMPEL)子研究

SUPERA stent outcomes in Above-The-Knee IntervEntions: Effects of COMPression and ELongation (SAKE-COMPEL) Sub-study.

作者信息

Bhatt Hemal, Kovach Richard, Janzer Sean, George Jon C

机构信息

Division of Cardiovascular Disease, Einstein Medical Center, Philadelphia, PA 19141, United States.

Division of Interventional Cardiology and Endovascular Medicine, Deborah Heart and Lung Center, Browns Mills, NJ 08015, United States.

出版信息

Cardiovasc Revasc Med. 2018 Jul;19(5 Pt A):512-515. doi: 10.1016/j.carrev.2017.11.007. Epub 2017 Nov 16.

DOI:10.1016/j.carrev.2017.11.007
PMID:29217340
Abstract

INTRODUCTION

The interwoven nitinol design of the Supera stent has been shown to have superior radial strength and fracture resistance resulting in higher patency rates at 6 and 12months. A detailed sub-analysis of SUPERB trial showed differences in patency based on stent conformation post deployment. We evaluated the patency of the stent within the SAKE study cohort based on stent deployment conformation.

METHODS

We retrospectively evaluated the medical records of 63 patients (77 limbs) with Rutherford class 2-5 symptoms who received Supera stents in the femoro-popliteal artery from March 2010 through May 2011 as part of the SAKE study. These patients were followed for patency and the need for re-intervention over a mean follow up of 15months. Compression or Elongation was defined as follows based on previous sub-analyses: Moderate Compression (-40 to -21%); Minimal Compression (-20 to -11%); Nominal (-10 to 10%); Minimal Elongation (11 to 20%); Moderate Elongation (21 to 40%); and Severe Elongation (>40%). Significance was determined using Chi X test.

RESULTS

The best patency rates (85.2% primary patency and 92.6% assisted primary patency) and lowest re-intervention rates (14.8%) were achieved with stent compression, followed by nominal deployment or minimal elongation, and worst outcomes (64.7% primary patency; 82.3% assisted primary patency; and 35.3% re-intervention) with stent elongation to moderate or severe degree.

CONCLUSIONS

Patency rates and re-intervention rates are variable based on deployment characteristics of the Supera stent. Best outcomes are achieved with compression of the stent during deployment.

摘要

引言

Supera支架的编织镍钛诺设计已显示出具有卓越的径向强度和抗断裂性,从而在6个月和12个月时具有更高的通畅率。SUPERB试验的详细亚组分析显示,基于支架展开后的形态,通畅情况存在差异。我们在SAKE研究队列中,根据支架展开形态评估了该支架的通畅情况。

方法

作为SAKE研究的一部分,我们回顾性评估了2010年3月至2011年5月期间在股腘动脉接受Supera支架治疗的63例(77条肢体)有卢瑟福2 - 5级症状患者的病历。这些患者接受了平均15个月的通畅情况和再次干预需求的随访。根据先前的亚组分析,压缩或伸长定义如下:中度压缩(-40%至-21%);轻度压缩(-20%至-11%);标称(-10%至10%);轻度伸长(11%至20%);中度伸长(21%至40%);重度伸长(>40%)。使用卡方检验确定显著性。

结果

支架压缩时实现了最佳通畅率(85.2%的初始通畅率和92.6%的辅助初始通畅率)和最低再次干预率(14.8%),其次是标称展开或轻度伸长,而支架伸长至中度或重度时结果最差(64.7%的初始通畅率;82.3%的辅助初始通畅率;35.3%的再次干预率)。

结论

Supera支架的通畅率和再次干预率因展开特征而异。展开过程中对支架进行压缩可实现最佳结果。

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