Final Results of the Prospective European Trial of the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair

Abstract

Objectives The Endurant Stent Graft System (Medtronic Vascular, Santa Rosa, CA) is specifically designed to treat patients with abdominal aortic aneurysm, including those with difficult anatomies. This is the 1-year report of a prospective, non-randomised, open-label trial at 10 European centres. Methods Between November 2007 and August 2008, 80 patients were enrolled for elective endovascular aneurysm repair (EVAR) with the Endurant; 71 with moderate (≤60°) and nine with high (60–75°) infrarenal aortic neck angulation. Safety and stent-graft performance were assessed throughout a 1-year follow-up period. Results The device was successfully delivered and deployed in all cases. All-cause mortality was 5% (4/80), with one possibly device-related death. Serious adverse events were comparable between the high and moderate angulation groups. There were no device migrations, stent fractures, aortic ruptures or conversions to open repair. Maximal aneurysm diameter decreased >5 mm in 42.7% of cases. A total of 28 endoleaks were observed (26 type II, two undetermined). Three secondary endovascular procedures were performed for outflow vessel stenosis, graft limb occlusion and iliac extension, resulting in a secondary patency rate of 100%. No re-interventions were required in the high angulation group. Conclusions The Endurant Stent Graft was successfully delivered and deployed in all cases and performed safely and effectively in all patients, including those with unfavourable proximal neck anatomy.