Two-year outcome of the Endurant stent graft for endovascular abdominal aortic repair in Japanese patients: incidence of endoleak and aneurysm sac shrinkage.

Background: We aimed to review 50 consecutive Japanese abdominal aortic aneurysm (AAA) and common iliac aneurysm (CIAA) patients to evaluate the 2-year outcomes, particularly endoleak and aneurysm sac shrinkage, of the Endurant stent graft.
Methods: Between June 2012 and January 2014, 50 consecutive Japanese AAA and CIAA patients underwent EVAR with the Endurant stent graft. Clinical outcomes of overall survival, aneurysm-related survival, and secondary intervention-free survival were analyzed; endoleaks and aneurysm sac changes were also evaluated.
Results: The 2-year Kaplan-Meier estimates for overall survival, aneurysm-related survival, and secondary intervention-free survival were 85.4%, 97.7% with one device-related death, and 84.9%, respectively. Type I, II, and III endoleaks at any one point (all comers) after EVAR were detected in 2 (4%), 6 (12%), and 3 (6%) patients, respectively, whereas type IV endoleak was detected in 19 (38%) patients. The percentage of patients with significant sac shrinkage was only 19% (7/37) of the patients at 2 years. Multivariate analysis detected hypertension as a significant factor affecting aneurysm sac shrinkage (OR: 0.09, 95% CI: 0.001-0.99, P=0.049).
Conclusions: The Endurant stent graft has demonstrated consistently successful clinical performance in Japanese patients for 2 years. However, the incidence of type IV endoleak was high, while the percentage of significant sac shrinkage was low. Careful and longer follow-up is required to determine the durability of the Endurant stent graft in Japanese patients.