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多中心意大利原发性主髂动脉闭塞性疾病血管内治疗登记研究结果。

Outcomes From the Multicenter Italian Registry on Primary Endovascular Treatment of Aortoiliac Occlusive Disease.

机构信息

Vascular Surgery, Department of Medicine and Surgery, ASST Settelaghi University Teaching Hospital, University of Insubria School of Medicine, Varese, Italy.

Vascular Surgery, Department of Cardiothoracic and Vascular Surgery, Careggi University Teaching Hospital, University of Florence School of Medicine, Florence, Italy.

出版信息

J Endovasc Ther. 2019 Oct;26(5):623-632. doi: 10.1177/1526602819863081. Epub 2019 Jul 22.

DOI:10.1177/1526602819863081
PMID:31331235
Abstract

To report the results of endovascular treatment of iliac and complex aortoiliac occlusive disease (AIOD) in a multicenter Italian registry. A retrospective, multicenter, observational cohort study analyzed 713 patients (mean age 68±10 years; 539 men) with isolated iliac and complex aortoiliac lesions treated with primary stenting between January 2015 and December 2017. Indications for treatment were claudication in 406 (57%) patients and critical limb ischemia in 307 (43%). According to the TransAtlantic Inter-Society Consensus II (TASC) classification, the lesions were categorized as type A (104, 15%), type B (171, 24%), type C (170, 24%), and type D (268, 37%). Early (<30 days) endpoints included mortality, thrombosis, and major complications. Late major outcomes were primary and secondary patency and freedom from reintervention as estimated by Kaplan-Meier analysis; estimates are given with the 95% confidence intervals (CIs). Associations between baseline variables and primary patency were sought with multivariate analysis; the results are presented as the hazard ratio (HR) and 95% CI. Technical success was achieved in 708 (99%) lesions; in-hospital mortality was 0.6% (n=4). The median follow-up was 11 months (range 0-42). The estimated primary patency rate was 96% (95% CI 94% to 97%) at 1 year and 94% (95% CI 91% to 96%) at 2 years. The estimated secondary patency was 99% (95% CI 97% to 99%) at 1 year and 98% (95% CI 95% to 99%) at 2 years. The estimated freedom from reintervention was 98% (95% CI 96% to 99%) at 1 year and 97% (95% CI 94% to 98.5%) at 2 years. Cox regression analysis demonstrated that the application of a covered stent was associated with an increased need for reintervention (HR 1.4, 95% CI 1.10 to 1.74, p=0.005). Chronic obstructive pulmonary disease was associated with decreased primary patency (HR 3.7, 95% CI 1.25 to 10.8, p=0.018). Endovascular intervention with primary stent placement for aortoiliac occlusive disease achieved satisfactory 2-year patency regardless of the complexity of the lesion. Almost all TASC lesions should be considered for primary endovascular intervention if suitable.

摘要

报告意大利多中心注册研究中血管内治疗髂动脉和复杂主髂动脉闭塞性疾病(AIOD)的结果。一项回顾性、多中心、观察性队列研究分析了 713 例(平均年龄 68±10 岁;539 例男性)孤立性髂动脉和复杂主髂动脉病变患者,这些患者于 2015 年 1 月至 2017 年 12 月期间接受了初次支架置入术。治疗的适应证为跛行 406 例(57%)和严重肢体缺血 307 例(43%)。根据跨大西洋腔内血管外科学会共识 II (TASC)分类,病变分为 A 型(104 例,15%)、B 型(171 例,24%)、C 型(170 例,24%)和 D 型(268 例,37%)。早期(<30 天)终点包括死亡率、血栓形成和主要并发症。晚期主要结局包括由 Kaplan-Meier 分析估计的原发性通畅率和继发性通畅率以及免于再次介入治疗;估计值给出了 95%置信区间(CI)。使用多变量分析探讨了基线变量与原发性通畅率之间的关系;结果以风险比(HR)和 95%CI 表示。708 个病变(99%)达到技术成功;院内死亡率为 0.6%(n=4)。中位随访时间为 11 个月(0-42 个月)。估计 1 年和 2 年的原发性通畅率分别为 96%(95%CI 94%至 97%)和 94%(95%CI 91%至 96%)。估计的继发性通畅率分别为 99%(95%CI 97%至 99%)和 98%(95%CI 95%至 99%)。估计的免于再次介入治疗率分别为 98%(95%CI 96%至 99%)和 97%(95%CI 94%至 98.5%)。Cox 回归分析表明,应用覆膜支架与需要再次介入治疗的风险增加相关(HR 1.4,95%CI 1.10 至 1.74,p=0.005)。慢性阻塞性肺疾病与原发性通畅率降低相关(HR 3.7,95%CI 1.25 至 10.8,p=0.018)。对于主髂动脉闭塞性疾病,采用初次支架置入术的血管内治疗可获得令人满意的 2 年通畅率,无论病变的复杂性如何。如果合适,几乎所有 TASC 病变都应考虑进行初次血管内介入治疗。

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