Presentation compares ENGAGE Global Registry with landmark EVAR 1 trial results

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A presentation at the Abdominal Aortic Aneurysm Challenges session during the 2016 Charing Cross Symposium (26–29 April, London, UK) has compared the ENGAGE global registry with results from the landmark EVAR 1 trial. The ENGAGE post-market registry has collected data on the Endurant abdominal aortic aneurysm (AAA) stent graft system (Medtronic).

Containing results for more than 1,200 patients at 79 sites across six continents, the registry aims to complete ten-year follow-up. A decade ago in a breakthrough conclusion, EVAR 1 demonstrated better aneurysm-related survival for EVAR over open surgery.

Roger Greenhalgh, Charing Cross chairman and author of the EVAR 1 Trial stated, “The EVAR 1 trial is the world’s first randomised, controlled trial of EVAR compared with open repair using devices implanted between 1999 and 2005. It is therefore an appropriate benchmark against which newer generation devices can be compared.”

Dittmar Böckler, Department of Vascular Surgery, University of Heidelberg, in Germany and ENGAGE investigator presented ENGAGE registry outcomes with reference to EVAR 1.

Aneurysm-related mortality was 1.6% in the ENGAGE registry through four years. EVAR 1 reported aneurysm-related mortality of 3.5% for EVAR and 6.3% for open surgery. The ENGAGE Registry also reported a lower rupture rate than in EVAR 1, as well as a decreased secondary intervention rate.

“In the comparison analysis of ENGAGE and EVAR 1 we can see just how far our medical advancements have come in improving patient outcomes with EVAR,” says Böckler. “The very well-structured EVAR 1 gave us the opportunity to understand the urgent need of improvement in EVAR, especially in mid- and long-term endograft behaviour. Thanks to large real world registries, such as ENGAGE, we can do scrupulous analysis of different subgroups’ outcomes.”

Selected for nearly one of every two endovascular abdominal aortic aneurysm (AAA) repairs globally, the Endurant system received CE mark in June 2008. US Food and Drug Administration (FDA) approval was received in December 2010. The Endurant stent graft system is approved outside of the USA for use in patients with AAA neck lengths ≥10mm and ≤60° infra-renal angulation and ≥15mm with≤75° infra-renal angulation. In the USQ, the Endurant stent graft system is indicated for necks ≥10 mm and ≤60° infra-renal angulation. At the 2015 VEITHsymposium, ENGAGE registry data demonstrated that the Endurant AAA stent graft can deliver durable, consistent and proven outcomes at four years in real-world settings.