Covered stents

覆膜支架
  • 文章类型: Journal Article
    覆盖的主动脉分叉腔内重建(CERAB)技术为涉及主动脉分叉的跨大西洋社会间共识(TASC)C/D病变提供了替代方案。该研究旨在使用Begraft球囊扩张覆膜支架(BECS)评估CERAB技术治疗广泛的主动脉闭塞性疾病(AIOD)的结果。
    这是医生发起的,多中心,回顾性,观察性研究。在2017年6月至2021年6月之间,所有使用Begraft支架(BentleyInnoMed,赫辛根,德国)在3个诊所注册。患者人口统计学,病变特征,收集和回顾性分析手术结果.在1、6和12个月进行随访,然后每年进行临床检查,踝肱指数(ABI),和双工超声。主要终点是12个月时的通畅性。次要终点包括手术相关并发症,二级通畅,无靶病变血运重建(TLR),和临床改善。
    总之,分析了120名患者(64名男性),中位年龄为65岁(范围:34-84岁)。大多数患者的广泛AIOD分类为TASCIIC(n=32;26.7%)或TASCIID(n=81;67.5%)。手术的中位持续时间为120分钟(四分位距[IQR]:80-180分钟)。所有454个Begraft支架(137个主动脉和317个外周)均成功递送和部署。手术并发症总发生率为14例(11.7%)。中位住院时间为5天(IQR:3-6天)。所有患者临床好转,ABI显著升高(p<0.05)。中位随访时间为19个月(6~56个月)。主要通畅率,二级通畅率,12个月时的TLR自由度为94.5%,97.3%,93.5%,分别。
    使用BegraftBECSs的CERAB程序具有很高的技术成功率,良好的通畅结果,低发病率,即使在患有广泛AIOD的相对疾病的患者中。绝对建议对CERAB技术进行前瞻性随机研究。
    结论:本研究评估了覆膜血管内重建主动脉分叉(CERAB)手术期间使用Begraft支架的结果。迄今为止,几种球囊扩张覆膜支架已用于该技术,结果令人满意。这项研究显示了CERAB技术在使用Begraft球囊扩张覆膜支架的广泛AIOD中的安全性和出色的通畅性。
    UNASSIGNED: The covered endovascular reconstruction of the aortic bifurcation (CERAB) technique offers an alternative for Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions involving the aortic bifurcation. The study aims to evaluate the outcomes of the CERAB technique for extensive aortoiliac occlusive disease (AIOD) using the BeGraft balloon-expandable covered stent (BECS).
    UNASSIGNED: This is a physician-initiated, multicenter, retrospective, observational study. Between June 2017 and June 2021, all consecutive patients who underwent the CERAB procedure using the BeGraft stent (Bentley InnoMed, Hechingen, Germany) in 3 clinics were enrolled. Patients\' demographics, lesion characteristics, and procedural results were collected and retrospectively analyzed. Follow-up was done at 1, 6, and 12 months and then annually with clinical examination, ankle-brachial index (ABI), and duplex ultrasound. The primary endpoint was the patency at 12 months. Secondary endpoints included procedural-related complications, secondary patency, freedom from target lesion revascularization (TLR), and clinical improvement.
    UNASSIGNED: In all, 120 patients (64 men) with a median age of 65 years (range: 34-84 years) were analyzed. Most patients had extensive AIOD classified as TASC II C (n=32; 26.7%) or TASC II D (n=81; 67.5%). The median duration of the procedure was 120 minutes (interquartile range [IQR]: 80-180 minutes). All 454 BeGraft stents (137 aortic and 317 peripheral) were successfully delivered and deployed. The overall procedural complication rate was 14 (11.7%). The median hospital length of stay was 5 days (IQR: 3-6 days). All patients improved clinically, and the ABI increased significantly (p<0.05). The median follow-up was 19 months (range: 6-56 months). The primary patency rate, secondary patency rate, and freedom from TLR at 12 months were 94.5%, 97.3%, and 93.5%, respectively.
    UNASSIGNED: The CERAB procedure with BeGraft BECSs has a high technical success rate, favorable patency outcomes, and low morbidity, even in relatively ill patients with extensive AIOD. Prospective randomized studies on the CERAB technique are definitely recommended.
    CONCLUSIONS: This study evaluates the outcomes of BeGraft stents used during the covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure. To date, several balloon-expandable covered stents have been used for this technique with satisfactory results. This study showed the safety and excellent patency of the CERAB technique in extensive AIOD using BeGraft balloon-expandable covered stents.
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  • 文章类型: Journal Article
    目的:有人认为,与裸金属支架(BMS)相比,覆膜支架(CS)可能降低髂总动脉血管内治疗后的再狭窄率。该试验旨在提供关于CS与BMS在髂总动脉。
    方法:这个多中心,随机化,单盲对照优势试验比较了球囊扩张CS和球囊扩张BMS治疗髂总动脉晚期动脉粥样硬化病变的疗效,定义为长度>3cm的狭窄或闭塞.主要终点是随访两年后无二元再狭窄。这项研究是根据《赫尔辛基宣言》(2008年10月版)的原则进行的,并在荷兰审判登记册(NTR3381)上注册。
    结果:在2012年至2019年期间,共纳入了174条肢体,每组87条肢体。六名患者从BMS组交叉到CS组,但根据意向治疗原则进行了分析。随访两年后,BMS组为84.7%(95%CI76.7-92.7%),CS组为89.1%(95%CI82.4-95.8%)(p=0.40)。BMS组的无闭塞率为95.0%(95%CI90.3-95.7%),CS组为96.4%(95%CI92.5-100%)(p=0.66)。靶病变血运重建的发生率为91.1%(95%CI84.8-97.3%)和95.2%(95%CI90.7-99.7%),分别(p=.31)。技术上的成功,并发症,血液动力学的成功,两组的临床成功率也相当.按方案分析不影响研究结果。
    结论:球囊扩张CS和BMS治疗髂总动脉晚期动脉粥样硬化病变没有差异。
    OBJECTIVE: It has been suggested that covered stents (CS) may lower restenosis rates compared with bare metal stents (BMS) after endovascular treatment of the common iliac artery. This trial aimed to provide additional evidence on the efficacy of CS vs. BMS in the common iliac artery.
    METHODS: This multicentre, randomised, single blind controlled superiority trial compared balloon expandable CS and balloon expandable BMS for advanced atherosclerotic lesions in the common iliac artery; this was defined as a stenosis > 3 cm in length or occlusion. The primary end point was freedom from binary restenosis after two years of follow up. The study was conducted according to the principles of the Declaration of Helsinki (version: October 2008) and registered with the Dutch Trial register (NTR3381).
    RESULTS: One hundred and seventy-four limbs were included between 2012 and 2019 with 87 limbs in each group. Six patients crossed over from the BMS group to the CS group but were analysed according to an intention to treat principle. Freedom from binary restenosis after two years of follow up was 84.7% (95% CI 76.7 - 92.7%) in the BMS group and 89.1% (95% CI 82.4 - 95.8%) in the CS group (p = .40). Freedom from occlusion was 95.0% (95% CI 90.3 - 95.7%) in the BMS group and 96.4% (95% CI 92.5 - 100%) in the CS group (p = .66). Freedom from target lesion revascularisation was 91.1% (95% CI 84.8 - 97.3%) and 95.2% (95% CI 90.7 -99.7%), respectively (p = .31). Technical success, complications, haemodynamic success, and clinical success were also comparable between both groups. Per-protocol analysis did not affect the outcomes of the study.
    CONCLUSIONS: No difference was found between balloon expandable CS and BMS for treating advanced atherosclerotic lesions of the common iliac artery.
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