用于治疗严重髂动脉和股动脉狭窄及闭塞的聚四氟乙烯涂层自膨式镍钛合金支架：一项前瞻性研究的最终结果

PTFE-covered self-expanding nitinol stents for the treatment of severe iliac and femoral artery stenoses and occlusions: final results from a prospective study.

作者信息

Wiesinger Benjamin, Beregi Jean-Paul, Oliva Vincent L, Dietrich Tobias, Tepe Gunnar, Bosiers Marc, Hüttl Kayman, Müller-Hülsbeck Stefan, Bray Alan, Tielemans Hans, Duda Stephan H

机构信息

Division of Diagnostic Radiology, Department of Radiology, University of Tübingen, Germany.

出版信息

J Endovasc Ther. 2005 Apr;12(2):240-6. doi: 10.1583/04-1327MR.1.

DOI:10.1583/04-1327MR.1

PMID:15823072

Abstract

PURPOSE

To evaluate the technical performance, safety, and 1-year clinical efficacy of polytetrafluoroethylene (PTFE)-covered nitinol stents in the treatment of atherosclerotic iliac and superficial femoral artery (SFA) disease.

METHODS

The multicenter, prospective, nonrandomized COVENT study involved 98 patients (70 men; mean age 64+/-10 years) who received PTFE-covered nitinol stents in 107 arteries (60 iliac and 47 SFAs) after predilation. The average lesion length was 50 mm in the SFA and 45 mm in the iliac arteries. Postdilation was performed when necessary. Duplex ultrasound and ankle-brachial index (ABI) were performed at discharge and at 1, 6, and 12 months in follow-up.

RESULTS

In total, 130 stents were placed successfully in 97 (99%) of 98 patients. One stent was misplaced during deployment and required subsequent surgical removal. The average stenosis grade was reduced from 98% to 6% in the SFAs and from 96% to 4% in the iliac arteries after covered stent placement. There was a significant rise of the mean ABI from 0.64 at baseline to 0.97 and 0.95 at 1 and 12 months, respectively (p<0.001). There were 7 primary covered stent occlusions (6.5% of 107 stented lesions: 3 not treated, 2 bypassed, 2 dilated or stented) and 5 (4.7%) recurrent in-stent occlusions (1 bypassed, 2 dilated, 2 untreated) during the 1-year follow-up. Primary patency rates were 92% at 6 months and 89.8% at 12 months for the entire cohort. Secondary patency rates were 98% and 95.6%, respectively. No statistically significant differences were observed in the primary patency rates for the SFAs (89.3% at both 6 and 12 months) versus the iliac arteries (94.3% at 6 months and 90.7% at 12 months).

CONCLUSIONS

Primary implantation of PTFE-covered nitinol stents in the iliac and superficial femoral arteries is technically feasible, safe, and effective, with excellent 1-year patency.

摘要

目的

评估聚四氟乙烯（PTFE）覆膜镍钛合金支架治疗髂动脉和股浅动脉（SFA）动脉粥样硬化疾病的技术性能、安全性及1年临床疗效。

方法

多中心、前瞻性、非随机的COVENT研究纳入了98例患者（70例男性；平均年龄64±10岁），这些患者在预扩张后于107条动脉（60条髂动脉和47条股浅动脉）植入了PTFE覆膜镍钛合金支架。股浅动脉平均病变长度为50 mm，髂动脉为45 mm。必要时进行后扩张。在出院时以及随访的1、6和12个月时进行双功超声和踝肱指数（ABI）检查。

结果

总共98例患者中的97例（99%）成功植入了130枚支架。1枚支架在植入过程中位置不当，随后需要手术取出。覆膜支架植入后，股浅动脉平均狭窄程度从98%降至6%，髂动脉从96%降至4%。平均ABI从基线时的0.64分别显著升至1个月时的0.97和12个月时的0.95（p<0.001）。在1年随访期间，有7例原发性覆膜支架闭塞（107个植入支架病变中的6.5%：3例未治疗，2例进行了搭桥手术，2例进行了扩张或再次植入支架）和5例（4.7%）复发性支架内闭塞（1例进行了搭桥手术，2例进行了扩张，2例未治疗）。整个队列6个月时的原发性通畅率为92%，12个月时为89.8%。继发性通畅率分别为98%和95.6%。股浅动脉（6个月和12个月时均为89.3%）与髂动脉（6个月时为94.3%，12个月时为90.7%）的原发性通畅率未观察到统计学上的显著差异。