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Objective <p>This retrospective cohort study aimed to emulate the ADVANCE trial population and directly compare the Endurant and Excluder using propensity score matching.</p> Methods <p>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&#xa0;mm at 1&#xa0;year. The secondary outcome measures were rates of freedom from late complications, T1aEL, sac enlargement ≥ 5&#xa0;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.</p> Results <p>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.</p> Conclusion <p>There were no significant differences in all clinical outcome measures between Endurant and Excluder.</p> <p>Levels of evidence:</p> <p>Level IV, multicenter retrospective cohort study.</p>

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Direct Comparison of Endurant Stent Graft System and Excluder Endoprosthesis using a Japanese Multicenter Registry

  • 期刊论文

  • 发表日期：

    2025年9月17日

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  • Kyosuke Hosokawa,
  • Naoki Fujimura,
  • Mitsuyoshi Takahara,
  • Hirohisa Harada,
  • Norio Uchida,
  • Taku Fujii,
  • Tsunehiro Shintani,
  • Susumu Watada,
  • Shigeshi Ono,
  • Yasuhito Sekimoto,
  • Tatsuya Shimogawara,
  • Keita Hayashi,
  • Hideaki Obara,
  • Yuko Kitagawa

摘要

Objective

This retrospective cohort study aimed to emulate the ADVANCE trial population and directly compare the Endurant and Excluder using propensity score matching.

Methods

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.

Results

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.

Conclusion

There were no significant differences in all clinical outcome measures between Endurant and Excluder.

Levels of evidence:

Level IV, multicenter retrospective cohort study.