PLIANTII研究：单侧或双侧主动脉-髂或髂动脉瘤患者使用E-liac支架系统治疗30天和1年的前瞻性多中心登记

IF 5.7 1区医学 Q1 PERIPHERAL VASCULAR DISEASE

European Journal of Vascular and Endovascular Surgery Pub Date : 2025-06-01 DOI:10.1016/j.ejvs.2025.02.029

Alexander Oberhuber , Sebastien Deglise , Olaf Richter , Vladimir Makaloski , Umberto Bracale , Giacomo Isernia , Roland Tines , Alessandro Cappelli , Bernhard Dorweiler , Jan Brunkwall

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引用次数: 0

摘要

目的：本研究的目的是前瞻性评估E-liac支架系统用于选择性治疗单侧或双侧髂总动脉瘤的实际结果。方法：PLIANTII是一项观察性、前瞻性、非随机、多中心研究。在2018年9月至2023年9月期间，欧洲30个中心的295名患者植入了E-liac支架移植系统，用于治疗髂动脉瘤，其中236名患者也接受了合并的肾下腹主动脉瘤治疗。终点，包括临床结果，报告到12个月的随访。主要终点是在12个月的随访中，无I型或III型内漏加上髂外动脉（EIA）和髂内动脉（IIA）在e -髂植入侧(s)的通畅。技术成功的定义是在出院或30天时评估支架成功进入和部署，无手术转换、死亡、I型或III型内漏或移植物肢体闭塞。临床成功，在12个月时评估，还包括没有支架感染和髂动脉瘤破裂。结果：共295例患者，其中男性95.6%；平均年龄72.7岁)。主要终点达到91.8%。植入后30天内无死亡记录，12个月时有7例死亡。Kaplan-Meier估计生存率至12个月随访时为96.7±1.2%。93.1%的患者在出院或30天内获得技术成功，而在12个月时获得临床成功的患者占91.2%。30天内再干预率为5.4%，12个月内再干预率为12.9%。Kaplan-Meier估计随访12个月前与E-liac相关的再干预自由度为91.3±1.8%。出院或30天就诊时，EIA的初级通畅率为97.6% (284/291)，IIA的初级通畅率为96.2%(280/291)，而Kaplan-Meier估计，EIA的通畅率为94.5±1.6%，IIA的通畅率为94.7±1.5%。结论：PLIANTII研究的一年数据表明，使用E-liac支架系统治疗是安全的，并且具有良好的技术和临床成功率。

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A Prospective, Multicentre Registry on Thirty Day and One Year Outcomes of the E-liac Stent Graft System in Patients with Unilateral or Bilateral Aorto-iliac or Iliac Aneurysms: The PLIANTII Study

Objective

The aim of this study was to prospectively evaluate the real world outcomes of the E-liac stent graft system used to electively treat common iliac artery aneurysms, either unilaterally or bilaterally.

Methods

PLIANTII is a prospective, observational, non-randomised, multicentre study. The E-liac stent graft system was implanted for the treatment of iliac artery aneurysms in 295 patients across 30 European centres between September 2018 and September 2023, with 236 patients also treated for a concomitant infrarenal abdominal aortic aneurysm. The endpoints, including clinical outcomes, are reported up to the twelve month follow up. The primary endpoint was a composite of freedom from type I or III endoleak plus patency of the external (EIA) and internal iliac arteries (IIA) on the E-liac implantation side(s) at the twelve month follow up. Technical success was defined as successful access and deployment of the stent graft without surgical conversion, death, type I or III endoleak, or graft limb occlusion, assessed at discharge or 30 days. Clinical success, evaluated at twelve months, also included the absence of stent graft infection and iliac aneurysm rupture.

Results

Two hundred and ninetyfive consecutive patients (95.6% male; mean age 72.7 years) were included. The primary endpoint was achieved in 91.8%. No death was recorded within 30 days of implantation, and seven deaths had occurred at twelve months. The Kaplan–Meier estimated survival rate up to the twelve month follow up visit was 96.7 ± 1.2%. Technical success at discharge or 30 days was achieved in 93.1% of patients, while clinical success at twelve months was achieved in 91.2%. There were 5.4% re-interventions within 30 days and 12.9% within twelve months. The Kaplan–Meier estimated freedom from E-liac related re-intervention up to the twelve month follow up visit was 91.3 ± 1.8%. The primary patency rate at discharge or 30 day visit was 97.6% (284/291) for the EIA and 96.2% (280/291) for the IIA, whereas Kaplan–Meier estimated freedom from occlusion up to twelve months was 94.5 ± 1.6% for the EIA and 94.7 ± 1.5% for the IIA.

Conclusion

The one year data from the PLIANTII study show that treatment with the E-liac stent graft system is safe and results in good technical and clinical success rates.

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来源期刊

European Journal of Vascular and Endovascular Surgery 医学-外科

CiteScore

6.80

自引率

15.80%

发文量

471

审稿时长

66 days

期刊介绍： The European Journal of Vascular and Endovascular Surgery is aimed primarily at vascular surgeons dealing with patients with arterial, venous and lymphatic diseases. Contributions are included on the diagnosis, investigation and management of these vascular disorders. Papers that consider the technical aspects of vascular surgery are encouraged, and the journal includes invited state-of-the-art articles. Reflecting the increasing importance of endovascular techniques in the management of vascular diseases and the value of closer collaboration between the vascular surgeon and the vascular radiologist, the journal has now extended its scope to encompass the growing number of contributions from this exciting field. Articles describing endovascular method and their critical evaluation are included, as well as reports on the emerging technology associated with this field.