Purpose: To compare the 1-year outcomes after repair of abdominal aortic aneurysms (AAA) with the bifurcated vs. aortouni-iliac (AUI) configuration of the Endurant stent-graft.
Methods: The study population comprised 1172 patients (1053 men; mean age 73.1±8.1 years, range 43-93) with unruptured infrarenal AAAs treated as part of the Endurant Stent Graft Natural Selection Global Post-market Registry (ENGAGE; ClinicalTrials.gov identifier NCT00870051). The primary outcome measure was treatment success at 12 months, defined by the composite of successful endograft deployment and the absence of type I/III endoleak, migration, rupture, or conversion to open surgery. Secondary outcome measures included endoleak, graft patency, migration, secondary procedures, and all-cause mortality.
Results: Among 1172 patients in ENGAGE, 1089 (92.9%) were treated with a bifurcated device and 83 (7.1%) received an AUI with femorofemoral bypass. Both groups were comparable with regard to demographics and baseline comorbidities, with the exception of a higher rate of cardiopulmonary disease in the AUI group. Successful deployment was achieved in all patients in the both groups. Postoperative complications occurred more frequently in the AUI patients, and the AUI group had an increased length of hospital stay (p=0.01). Endoleaks were more frequent in the AUI group at the conclusion of the procedure, a difference that vanished by 30 days. At 1 year, there were no incidences of graft kinking or stent fracture in either group. The rate of secondary procedures (5.3% in AUI patients and 4.9% for bifurcated cases) and all-cause mortality (10.5% and 8.6%, respectively) were similar in the two groups at 30 days and 1 year.
Conclusion: The results of endovascular aneurysm repair with an Endurant AUI device appear similar to that after a bifurcated endovascular repair, with the exception of an increased length of hospital stay in the AUI group. An AUI device should be considered as an option in patients with anatomy unsuitable for a bifurcated repair.