The latest-generation stent graft for the treatment of abdominal aortic aneurysms (AAAs), the Endurant Stent Graft (Medtronic, Inc., Minneapolis, MN), obtained CE Mark approval in July 2008 and was market released in over 88 countries based on previously collected clinical premarket data. The ENGAGE (Endurant Stent Graft Natural Selection Global Postmarket Registry) study has been initiated to prospectively collect global realworld safety and clinical performance data on the Endurant stent graft device and to create a database that can be pooled and compared with other available stent graft data.

METHODS
ENGAGE is a multicenter, noninterventional, nonrandomized, single-arm prospective study. It aims to recruit approximately 1,200 patients with an indication for elective AAA repair on an intention-to-treat basis from 80 sites throughout Europe, Asia, South Africa, the Middle East, Latin America, and Canada and will follow these patients for 5 years postimplantation. Patients fulfilling the eligibility criteria are being consecutively enrolled. The primary endpoint is treatment success, which comprises freedom from stent graft technical observations (stent graft migration, patency or integrity issues, endoleaks, aneurysm expansion), freedom from (serious) adverse device effects, freedom from major adverse events, and aneurysm-related and all-cause mortality. These endpoints are to be evaluated annually.

An interim analysis was performed based on investigatorreported data for the first 180 patients that were enrolled. These patients were asymptomatic elderly men (92.1%) with considerable comorbidities. Of these patients, 47.3% were American Society of Anesthesiologists risk class III or IV. The Endurant stent graft was successfully deployed in 99.4% of patients for the elective treatment of AAAs.

RESULTS
Through 30 days, the rate of all-cause mortality was 1.7% (n = 3), with all three deaths being classified as procedurerelated but not device-related. The 30-day mortality rate of 1.7% in these initial results is in line with the range of 1% to 3% reported in the literature for other current-generation endografts.1 The rate of secondary endovascular procedures was 1.1%, and the rate of conversion to open repair was 0.6%. At postprocedure and at 30-day follow-up, there were no type I or type III endoleaks and no instances of stent graft kinking, thrombosis, or occlusion. ENGAGE represents the largest real-world registry for any single stent graft for endovascular aneurysm repair.

CONCLUSION
The 30-day interim results of the first 180 patients enrolled in ENGAGE are promising. Longer-term followup for more ENGAGE patients will be reported. ENGAGE, unprecedented in size, scope, and geographical involvement, will closely monitor the real-world performance of the Endurant Stent Graft System. It will provide physicians with data that are intended to help optimize the minimally invasive treatment of AAA in the real-world setting of standard clinical practice.

Vincent Riambau, MD, PhD, is Professor and Chief of Vascular Surgery Division, Thorax Institute, Hospital Clinic, University of Barcelona in Spain. He has disclosed that he is a consultant/advisor to Aptus Endosystems, Bolton Medical, Cordis Corporation, Medtronic, Inc., Trivascular, and W. L. Gore & Associates. Dr. Riambau may be reached at riambau@meditex.es.

Dittmar Böckler, MD, PhD, is with the Department of Vascular and Endovascular Surgery, University of Heidelberg in Germany. He has disclosed that he is a paid consultant to Medtronic, Inc., and W. L. Gore & Associates. Dr. Böckler may be reached at dboeckler@me.com.

  1. Böckler D, Fitridge R, Wolf Y, et al. Rationale and design of the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE): interim analysis at 30 days of the first 180 patients enrolled. J Cardiovasc Surg (Torino). 2010;51:481-491.