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

Area of Science:

• Vascular Surgery
• Endovascular Aneurysm Repair
• Medical Device Comparison

Background:

• Endovascular Aneurysm Repair (EVAR) is a common treatment for abdominal aortic aneurysms (AAA).
• Device selection is crucial for optimal patient outcomes.
• Direct comparisons between commonly used EVAR devices are essential.

Purpose of the Study:

• To emulate the ADVANCE trial population and compare the outcomes of Endurant and Excluder EVAR devices.
• To assess sac regression, freedom from late complications, and overall survival after EVAR.

Main Methods:

• Retrospective cohort study of 266 matched pairs undergoing EVAR in Japan (2012-2022).
• Propensity score matching was used to minimize bias and emulate a randomized controlled trial.
• Primary outcome: sac regression ≥ 5 mm at 1 year. Secondary outcomes: freedom from late complications, T1aEL, sac enlargement ≥ 5 mm, and overall survival.

Main Results:

• No significant differences in sac regression (primary outcome) between Endurant and Excluder (within-IFU: 38.9% vs 36.6%; total cohort: 33.5% vs 35.0%).
• No significant differences in secondary outcomes, including overall survival.
• Higher rates of T2EL and proximal cuff use with Excluder; higher rates of T1b and T5ELs with Endurant in the total cohort.

Conclusions:

• Endurant and Excluder EVAR devices demonstrated comparable clinical outcomes in this propensity score-matched cohort.
• Device-specific complications were observed but did not translate to significant differences in major clinical endpoints.