Institut Vasculaire Paris Est, Hopital Privé Paul d'Egine, Ramsay Group Champigny, France.
Centre Hospitalier d'Avignon, France.
Eur J Vasc Endovasc Surg. 2021 Jan;61(1):98-105. doi: 10.1016/j.ejvs.2020.08.034. Epub 2020 Sep 29.
Endovascular repair is the preferred method of treatment for infrarenal abdominal aortic aneurysms with numerous publications from multiple geographic regions showing excellent patient outcomes. Since the original ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) randomised control trial, studies of French specific population have also contributed significantly to the body of evidence in support of endovascular abdominal aortic repair.
In the ENDURANT France registry, 180 patients were consecutively enrolled from 20 French centres starting in 2012. Investigational sites included public and private practice and differing centre volumes to be as representative of real world French experience as possible. The aim of this study was to present the five year outcomes from this registry.
Instructions for use (IFU) were respected in 97.8% (176/180) of patients. At five years, the Kaplan-Meier overall survival was 69.9% ± 3.5% and the freedom from aneurysm related death was 97.6% ± 1.2%. The freedom from Type IA endoleaks was 94.5% ± 1.7%, freedom from endoleaks of any type was 70.1 ± 3.4%, and freedom from secondary endovascular procedure 90.4% ± 2.6%. In addition, 61.6% (45/73) of patients exhibited sac shrinkage at five years.
In this five year report of the Endurant France registry, survival, re-intervention, and freedom from endoleak rates were comparable to recent EVAR registries and there was a high sac shrinkage rate. Secondary procedure and aneurysm rupture were lower than those of ACE, the French RCT which included older generation devices. This prospective registry demonstrates favourable five year outcomes of the Endurant stent graft used within IFU.
血管内修复是治疗肾下型腹主动脉瘤的首选方法，来自多个地理区域的大量出版物表明患者的治疗效果极佳。自最初的 ACE（腹主动脉瘤：手术与血管内修复）随机对照试验以来，针对法国特定人群的研究也为支持血管内腹主动脉修复的证据提供了重要依据。
在 ENDURANT France 注册研究中，2012 年从法国 20 个中心连续入组 180 例患者。研究中心包括公立和私立医疗机构，以及不同的中心容量，以尽可能代表法国的真实临床经验。本研究旨在报告该注册研究的 5 年结果。
在 180 例患者中，97.8%（176/180）的患者符合使用说明。5 年时，Kaplan-Meier 总体生存率为 69.9%±3.5%，与动脉瘤相关的死亡率为 97.6%±1.2%。IA 型内漏的无复发率为 94.5%±1.7%，任何类型内漏的无复发率为 70.1%±3.4%，二次血管内治疗的无复发率为 90.4%±2.6%。此外，61.6%（45/73）的患者在 5 年后出现了瘤腔缩小。
在 ENDURANT France 注册研究的 5 年报告中，生存率、再次干预和内漏无复发率与最近的 EVAR 注册研究相当，并且瘤腔缩小率较高。二次手术和动脉瘤破裂的发生率低于 ACE 试验（包括了较老一代设备）。这项前瞻性注册研究表明，在符合使用说明的情况下，Endurant 支架移植物具有良好的 5 年疗效。
