VIVA 2011: Short- and Mid-Term ENGAGE Study Results for AAA Stent Graft

October 19, 2011—At the VIVA 2011: Vascular Interventional Advances meeting in Las Vegas, Nevada, Marc Schermerhorn, MD, presented short- and mid-term results from the ENGAGE registry. ENGAGE was undertaken to quantify real-world outcomes after endovascular abdominal aortic aneurysm (AAA) repair with the Endurant stent graft (Medtronic, Inc., Minneapolis, MN) in a large, contemporary, global series of patients.

Dr. Schermerhorn stated that the registry was composed of 1,200 AAA patients who were enrolled at 77 clinical sites in 30 countries from March 2009 to November 2010 and treated with the Endurant stent graft. Follow-up data were tabulated for all 1,200 patients at 30 days and, for the first 350 patients, at 1-year. Results were described following the reporting standards for endovascular aneurysm repair.

Of the 1,200 patients in the study, 89.8% were men. The mean age was 73.3 ± 8.1 years, with an age range of 43 to 93 years. The mean AAA diameter was 60 ± 12 mm. The AAA was symptomatic in 15.4% patients, and 52.8% of patients were classified as American Society of Anesthesiologists class III or IV.

The investigators found that intraoperative technical and clinical success was achieved in 99.1% and 97.7% of cases, respectively, with a mean procedure time of 100 ± 45 minutes.

Within 30 days, one or more major adverse events were reported in 4.1% of patients, with a 1.3% mortality rate. Type I or III endoleaks were identified in 1.2% and 0.2% of patients, respectively. At 1 year, AAA-related mortality was 1.8%; each death was related to complications of the procedure and not the device.

Dr. Schermerhorn reported that secondary surgical interventions within 1 year were performed in 4.9% of cases. There were no instances of graft migration or aneurysm rupture. The one-year Kaplan-Meier estimate for overall survival was 91% (SE = .016), with a 1-year aneurysm-related mortality rate of 1.8% (SE = .007). At 1 year, aneurysm size was stable or had decreased ≥ 5 mm in 97% of cases.

The short- and mid-term clinical outcomes after endovascular AAA repair with the Endurant stent graft in a real-world, global experience are excellent across different geographies and standards of care, concluded the ENGAGE investigators.