Hosokawa Kyosuke, Fujimura Naoki, Takahara Mitsuyoshi, Harada Hirohisa, Uchida Norio, Fujii Taku, Shintani Tsunehiro, Watada Susumu, Ono Shigeshi, Sekimoto Yasuhito, Shimogawara Tatsuya, Hayashi Keita, Obara Hideaki, Kitagawa Yuko
Department of Vascular Surgery, Saiseikai Central Hospital, Tokyo, Japan.
Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
Cardiovasc Intervent Radiol. 2025 Sep 17. doi: 10.1007/s00270-025-04160-1.
This retrospective cohort study aimed to emulate the ADVANCE trial population and directly compare the Endurant and Excluder using propensity score matching.
Patients were included if endovascular aneurysm repair was performed for abdominal aortic aneurysm using either Endurant or Excluder at 10 hospitals in Japan between January 2012 and July 2022. Cases were selected according to the modified ADVANCE trial inclusion and exclusion criteria. To minimize selection bias and simulate a randomized controlled trial setting, propensity score matching was performed using patient and anatomical characteristics. The primary outcome measure was the proportion of patients with sac regression ≥ 5 mm at 1 year. The secondary outcome measures were rates of freedom from late complications, T1aEL, sac enlargement ≥ 5 mm, and overall survival. Outcomes were first analyzed in patients within the instructions for use (IFU) and then in all matched patients including outside IFU patients.
After matching, the within-IFU group included 124 pairs and the total cohort of 266 pairs. The primary outcome measures for Endurant and Excluder were met in 38.9% and 36.6% (p = 0.74) in the within-IFU group and 33.5% and 35.0% (p = 0.74) in the total cohort, respectively. No significant differences were observed in any secondary outcome measures. However, T2EL and use of additional proximal cuff were significantly more frequent for Excluder in both the within-IFU and total cohort. Furthermore, T1b and T5ELs occurred significantly more for Endurant in the total cohort.
There were no significant differences in all clinical outcome measures between Endurant and Excluder.
Level IV, multicenter retrospective cohort study.
这项回顾性队列研究旨在模拟ADVANCE试验人群，并使用倾向评分匹配法直接比较Endurant和Excluder两种产品。
纳入2012年1月至2022年7月期间在日本10家医院使用Endurant或Excluder对腹主动脉瘤进行血管内动脉瘤修复的患者。根据修改后的ADVANCE试验纳入和排除标准选择病例。为尽量减少选择偏倚并模拟随机对照试验环境，使用患者和解剖学特征进行倾向评分匹配。主要结局指标是1年时瘤囊缩小≥5 mm的患者比例。次要结局指标是无晚期并发症、T1aEL、瘤囊增大≥5 mm以及总生存率。首先对使用说明书（IFU）范围内的患者进行结局分析，然后对包括IFU范围外患者在内的所有匹配患者进行分析。
匹配后，IFU范围内的组有124对，总队列有266对。在IFU范围内的组中，Endurant和Excluder的主要结局指标分别为38.9%和36.6%（p = 0.74），在总队列中分别为33.5%和35.0%（p = 0.74）。在任何次要结局指标中均未观察到显著差异。然而，在IFU范围内的组和总队列中，Excluder的T2EL和额外近端袖带的使用频率均显著更高。此外，在总队列中，Endurant的T1b和T5EL发生率显著更高。
Endurant和Excluder在所有临床结局指标上均无显著差异。
IV级，多中心回顾性队列研究。
