Four-Year Results Reported From Pivotal Trial of Medtronic's Endurant AAA Stent Graft

November 5, 2014—VIVA Physicians, Inc. announced that 4-year results from a prospective, single-arm, multicenter trial conducted at 26 sites in the United States to evaluate the Endurant stent graft system (Medtronic, Inc.) for the treatment of abdominal aortic aneurysms (AAAs) were presented by Edward Woo, MD, during a late-breaking trials session at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.

As summarized in the VIVA announcement, the study was composed of 150 patients with AAA who were treated with the Endurant bifurcated stent graft from April 2008 to May 2009. The main inclusion criteria were an AAA diameter > 5 cm, proximal neck length ≥ 10 mm, bilateral iliac fixation length ≥ 15 mm, and a neck angulation of ≤ 60°. A clinical events committee adjudicated all adverse events except blood loss, and a core laboratory reviewed all imaging.

The primary safety endpoint was freedom from major adverse events at 30 days, and the primary effectiveness endpoint was successful aneurysm treatment at 12 months.

In the study, 149 patients (99.3%) had a successful stent graft implantation, with 83.3% of procedures conducted using general anesthesia. One failure was caused by the inability to cannulate the contralateral gate. One patient developed a neck rupture during the procedure, but was still treated successfully. Patients were predominantly male (91.3%), elderly (mean age, 73.1 years), and had significant comorbidities.

Dr. Woo reported that mean estimated blood loss was 185 mL (range, 0–1,450 mL), with blood transfusion required in one patient. Average hospital stay was 2.1 days. Through 48 months of follow-up, there were no migrations, ruptures, or conversions. There was one type I endoleak and no type III endoleaks at 48 months. There were low rates of AAA sac enlargement and secondary procedures. Midterm results of the Endurant pivotal trial are encouraging and suggest a safe and effective device for the treatment of AAAs, according to the VIVA summary.