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SMART支架与Luminexx镍钛诺支架植入治疗主髂动脉疾病的临床结果:一项倾向评分匹配的多中心研究

Clinical Outcomes of SMART Versus Luminexx Nitinol Stent Implantation for Aortoiliac Artery Disease: A Propensity Score-Matched Multicenter Study.

作者信息

Shintani Yoshiaki, Soga Yoshimitsu, Takahara Mitsuyoshi, Iida Osamu, Kawasaki Daizo, Yamauchi Yasutaka, Suzuki Kenji, Hirano Keisuke, Kawasaki Tomohiro

机构信息

Department of Cardiology, Cardiovascular Center, Shin-Koga Hospital, Kurume, Japan

Department of Cardiology, Kokura Memorial Hospital, Kitakyusyu, Japan.

出版信息

Angiology. 2015 Oct;66(9):875-81. doi: 10.1177/0003319714564207. Epub 2014 Dec 24.

Abstract

BACKGROUND

Endovascular therapy for aortoiliac (AI) lesions using stents is widely accepted. However, the long-term outcome of 2 different types of nitinol stents for AI lesions is unknown. The aim of this study was to examine the long-term outcome of the SMART and Luminexx nitinol stents for the treatment of de novo AI lesions.

METHODS

This study was a multicenter retrospective analysis of a prospectively maintained database. The study enrolled consecutive patients undergoing primary stenting for de novo AI artery stenosis between January 2005 and December 2009. A total of 1503 lesions in 1229 patients treated with SMART or Luminexx primary stenting were enrolled. The primary end point was primary patency, secondary end points were the primary assisted patency, secondary patency, and major adverse limb events (MALEs), which included major amputation and major reintervention. To minimize the differences between the groups, a propensity score matching analysis was performed, and 284 lesions per group were analyzed to identify outcomes.

RESULTS

After the propensity score matching analysis, the lesion length was 60 ± 37 and 57 ± 31 mm (P = .275), and the reference vessel diameter was 8.2 ± 1.5 and 8.3 ± 1.5 mm (P = .482) in the SMART and Luminexx groups, respectively. The primary patency at 3 years was not significantly different between the groups (83.5% vs 82.2%, P = .842, respectively). The assisted primary patency and secondary patency rates were also not significantly different (91.7% vs 93.2%, P = .340, 99.2% vs 98.8%, P = .922). In addition, the MALE rate was not significantly different between the groups (98.3% vs 97.3%, P = .821).

CONCLUSION

The current data suggest that the use of nitinol stents for the AI artery provided good long-term patency and freedom from MALE for 3 years of follow-up, regardless of whether SMART or Luminexx stents were used.

摘要

背景

使用支架对主髂动脉(AI)病变进行血管内治疗已被广泛接受。然而,两种不同类型的镍钛合金支架用于AI病变的长期疗效尚不清楚。本研究的目的是探讨SMART和Luminexx镍钛合金支架治疗初发性AI病变的长期疗效。

方法

本研究是对一个前瞻性维护数据库的多中心回顾性分析。该研究纳入了2005年1月至2009年12月期间因初发性AI动脉狭窄接受初次支架置入术的连续患者。共有1229例接受SMART或Luminexx初次支架置入术治疗的患者中的1503处病变被纳入研究。主要终点是初次通畅率,次要终点是初次辅助通畅率、二次通畅率和主要肢体不良事件(MALE),后者包括大截肢和主要再次干预。为尽量减少组间差异,进行了倾向评分匹配分析,并对每组284处病变进行分析以确定疗效。

结果

经过倾向评分匹配分析后,SMART组和Luminexx组的病变长度分别为60±37和57±31mm(P = 0.275),参考血管直径分别为8.2±1.5和8.3±1.5mm(P = 0.482)。两组间3年时的初次通畅率无显著差异(分别为83.5%对82.2%,P = 0.842)。辅助初次通畅率和二次通畅率也无显著差异(91.7%对93.2%,P = 0.340;99.2%对98.8%,P = 0.922)。此外,两组间的MALE发生率无显著差异(98.3%对97.3%,P = 0.821)。

结论

目前的数据表明,无论使用SMART还是Luminexx支架,镍钛合金支架用于AI动脉在3年随访期内均能提供良好的长期通畅率且无MALE发生。

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