外周动脉中OptiMed鼻窦支架的临床经验。

Clinical experience with the OptiMed sinus stent in the peripheral arteries.

作者信息

Henry Michel, Henry Isabelle, Klonaris Christos, Hugel Michele

机构信息

I.L.R.M.D.T, Nancy, France.

出版信息

J Endovasc Ther. 2003 Aug;10(4):772-9. doi: 10.1177/152660280301000414.

DOI:10.1177/152660280301000414

PMID:14533964

Abstract

PURPOSE

To retrospectively evaluate the performance of a new self-expanding nitinol stent in the treatment of lower limb arterial occlusive lesions.

METHODS

The Sinus stent is a flexible, laser-cut device with good radiopacity and radial strength, allowing precise placement via a 7-F introducer, even in tortuous arteries. Over a 3.5-year period, 315 patients (254 men; mean age 64.9+/-10.8 years, range 39-93) had 403 lower limb lesions treated: 172 iliac (132 stenoses, 40 occlusions), 204 femoral (131 stenoses, 73 occlusions), and 27 popliteal (19 stenoses, 8 occlusions). The majority of patients (272, 86%) were in stage IIb of Fontaine's classification, 31 (10%) in stage III, and 12 (4%) in stage IV. Mean lesion lengths were iliac: 51.9+/-32.1 mm, femoral: 66.3+/-51.5 mm, and popliteal: 44.3+/-27.2 mm. Indications for stenting were 222 postdilation residual stenoses, 125 dissections, and 35 restenoses; 21 lesions were directly stented.

RESULTS

Immediate technical success was 100%. Clinical success was 98%. The ankle-brachial index increased from 0.62+/-0.12 to 0.91+/-0.14. In 64 lesions, there were 3 early thromboses. Mean follow-up was 16.1+/-9.7 months (range to 40). There were 79 restenotic episodes: 14 iliac, 56 femoral, and 9 popliteal. Primary and secondary patencies for all lesions at 3 years were 72.5%+/-6.6% and 81.8%+/-5.9%, respectively. Stenoses demonstrated better patency than occlusions (primary: 78.0%+/-7.3% versus 60.2%+/-7.1%, p<0.001; secondary: 86.8%+/-6.1% versus 71.3%+/-6.7%, p<0.001). Men had better secondary patency at 3 years (83.7% versus 73.4%, p<0.05). For femoral lesions >8 cm, the results were acceptable for stenoses (66.7% primary and secondary patency at 3 years), but for lengthy occlusions, the restenosis rate was high (50.0% for occlusions versus 25.0% for stenoses, p<0.05).

CONCLUSIONS

Angioplasty with the Sinus stent seems safe and effective in the treatment of peripheral arterial occlusive diseases, giving excellent results at the iliac and common femoral artery levels. Treatment results are better for stenoses than for occlusions. An occlusion length <or=8 cm seems to be the limit for stenting.

摘要

目的

回顾性评估一种新型自膨式镍钛合金支架治疗下肢动脉闭塞性病变的性能。

方法

Sinus支架是一种灵活的、经激光切割的装置，具有良好的显影性和径向支撑力，即使在迂曲的动脉中也能通过7F导管鞘精确放置。在3.5年的时间里，315例患者（254例男性；平均年龄64.9±10.8岁，范围39 - 93岁）的403处下肢病变接受了治疗：172处髂动脉病变（132处狭窄，40处闭塞），204处股动脉病变（131处狭窄，73处闭塞），27处腘动脉病变（19处狭窄，8处闭塞）。大多数患者（272例，86%）处于Fontaine分级IIb期，31例（10%）处于III期，12例（4%）处于IV期。平均病变长度为：髂动脉51.9±32.1mm，股动脉66.3±51.5mm，腘动脉44.3±27.2mm。支架置入的适应证为222处球囊扩张后残余狭窄、125处夹层和35处再狭窄；21处病变直接置入支架。

结果

即刻技术成功率为100%。临床成功率为98%。踝肱指数从0.62±0.12增加到0.91±0.14。64处病变中有3处发生早期血栓形成。平均随访时间为16.1±9.7个月（范围至40个月）。有79次再狭窄事件：14处髂动脉，56处股动脉，9处腘动脉。所有病变3年时的一期通畅率和二期通畅率分别为72.5%±6.6%和81.8%±5.9%。狭窄病变的通畅情况优于闭塞病变（一期：78.0%±7.3%对60.2%±7.1%，p<0.001；二期：86.8%±6.1%对71.3%±6.7%，p<0.001）。男性3年时的二期通畅情况更好（83.7%对73.4%，p<0.05）。对于股动脉病变长度>8cm的情况，狭窄病变的结果尚可接受（3年时一期和二期通畅率为66.7%），但对于长段闭塞病变，再狭窄率较高（闭塞病变为50.0%，狭窄病变为25.0%，p<0.05）。