AMS INSIGHT--absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis.
AMS INSIGHT--absorbable metal stent implantation for treatment of below-the-knee critical limb ischemia: 6-month analysis.
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DOI：
10.1007/s00270-008-9472-8
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发表时间：
2009-05
影响因子：
2.9
通讯作者：
Bosiers, Marc
中科院分区：
文献类型：
--
作者：
Bosiers, Marc
关键词：
膝下动脉病变的腔内治疗是一个有争议的问题。生物可吸收支架作为一种将联合收割机机械预防血管回缩与长期前景优势相结合的手段进行了讨论。没有永久性金属植入物的可能性可能允许发生正性重塑，管腔扩大，以补偿新病变的发展。本研究旨在基于1个月和6个月的临床随访以及基于6个月血管造影通畅率的有效性研究可吸收金属支架（AMS）在膝下动脉中的安全性。117例慢性肢体缺血（CLI）患者（149处病变）被随机分配至AMS植入术（60例患者，74处病变）或独立经皮腔内血管成形术（PTA; 57例患者，75处病变）。7名PTA组患者“交叉”接受AMS支架植入术。研究人群包括患有症状性CLI（Rutherford分类4和5）和膝下动脉新发狭窄（>50%）或闭塞性动脉粥样硬化疾病的患者，这些患者的参考直径在3.0和3.5 mm之间，病变长度<15 mm。主要安全性终点定义为首次介入后30天内无大截肢和/或死亡，主要有效性终点为经核心实验室定量血管分析证实的6个月血管造影通畅率。在随机接受单独PTA和PTA后AMS植入的患者中，30天并发症发生率分别为5.3%（3/57）和5.0%（3/60）。在意向治疗基础上，AMS治疗病变的6个月血管造影通畅率（31.8%）显著低于（p = 0.013）PTA治疗病变的通畅率（58.0%）。尽管本研究表明AMS技术可以安全应用，但其在膝下血管的长期通畅性方面未证明优于标准PTA。
Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients “crossed over” to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.
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影响因子：
2.6
作者：
Peeters, P;Bosiers, M;Heublein, B
通讯作者：
Heublein, B
影响因子：
2.3
作者：
Waksman, Ron;Pakala, Rajbabu;Haverich, Axel
通讯作者：
Haverich, Axel
影响因子：
2.3
作者：
Commeau, Philippe;Barragan, Paul;Roquebert, Pierre O.
通讯作者：
Roquebert, Pierre O.
影响因子：
3
作者：
Favaretto, Elisabetta;Pili, Caterina;Palareti, Gualtiero
通讯作者：
Palareti, Gualtiero
影响因子：
2.6
作者：
Siablis, D;Kraniotis, P;Tsolakis, J
通讯作者：
Tsolakis, J