Iliac Artery Stenting versus Open Surgical Reconstruction for Complex Unilateral Iliac Lesions: a Randomized Trial.

IF 1.6 4区医学 Q3 PERIPHERAL VASCULAR DISEASE

Annals of vascular surgery Pub Date : 2025-09-16 DOI:10.1016/j.avsg.2025.08.046

Shoraan Saaya, Alexander Gostev, Olesia Osipova, Vladimir Starodubtsev, Pavel Ignatenko, Vyacheslav Mitrofanov, Cheban Aleksey, Emin Valiev, Andrey Karpenko, Alexander Chernyavskiy

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引用次数: 0

Abstract

The aim of this study was to compare the safety and effectiveness of endovascular treatment (ET) and open surgical reconstruction (OR) in patients with complex unilateral iliac lesions sparing the common femoral artery.

Materials and methods: From August 2015 till November 2020, eligible patients presenting with steno-occlusive iliac lesions (TASC types C, D) were randomized to either ET or OR. The prespecified primary outcomes were technical success, 30-day primary and secondary patency, and complication rates. Secondary outcomes were major adverse limb events, primary and secondary patency all at 36 months.

Results: Of the 450 patients evaluated, 202 were randomized (101 in the ET group and 101 in the OR group). The average length of hospital stay was shorter in the ET (p<.001). The 30-day postoperative complication rate was 3.96% in the ET group and 15.84% in the OR group (p = .005). The primary patency rates at 36 months were 88.12% in the OR group and 75.25 % in the ET group (HR 0.44, 95% CI 0.22; 0.89, p=.022). Secondary patency at 36 months was 99.01% and 95.05% (HR 0.19, 95% CI 0.02;1.69, p=.13). Amputation free survival at 36 months were 84.16% and 85.15% in OR and ET (HR 1.17, 95% CI 0.54; 2.53, p=.68).

Conclusions: This randomized trial found that ET was associated with a significantly shorter hospital stay and lower rates of postoperative complications, while secondary patency rates up to 3 years were not different. However, the primary patency at 36 months was significantly higher after OR.

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髂动脉支架置入与开放手术重建治疗复杂单侧髂病变：一项随机试验。

本研究的目的是比较血管内治疗（ET）和开放手术重建（OR）对保留股总动脉的复杂单侧髂病变患者的安全性和有效性。材料与方法：2015年8月至2020年11月，将符合条件的髂狭窄闭塞病变（TASC C型、D型）患者随机分为ET组和or组。预先指定的主要结果是技术成功、30天的原发性和继发性通畅以及并发症发生率。次要结局为36个月时主要肢体不良事件、原发性和继发性通畅。结果：在评估的450例患者中，202例被随机分配（ET组101例，OR组101例）。结论：这项随机试验发现，ET与显著缩短住院时间和降低术后并发症发生率相关，而长达3年的二次通畅率没有差异。然而，手术后36个月的原发性通畅率明显高于手术前。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of vascular surgery 医学-外科

CiteScore

3.00

自引率

13.30%

发文量

603

审稿时长

50 days

期刊介绍： Annals of Vascular Surgery, published eight times a year, invites original manuscripts reporting clinical and experimental work in vascular surgery for peer review. Articles may be submitted for the following sections of the journal: Clinical Research (reports of clinical series, new drug or medical device trials) Basic Science Research (new investigations, experimental work) Case Reports (reports on a limited series of patients) General Reviews (scholarly review of the existing literature on a relevant topic) Developments in Endovascular and Endoscopic Surgery Selected Techniques (technical maneuvers) Historical Notes (interesting vignettes from the early days of vascular surgery) Editorials/Correspondence