August 18, 2019
Five-Year Data Published for ENGAGE Global Registry of Medtronic's Endurant EVAR Device
August 19, 2019—Five-year outcomes of the Endurant stent graft (Medtronic) for endovascular abdominal aortic aneurysm (AAA) repair (EVAR) in the ENGAGE global postmarket registry were published by Joep A.W. Teijink, MD, et al in European Journal of Vascular and Endovascular Surgery (EJVES; 2019;58:175–181).
According to the investigators, the aim of this study is to present standard EVAR outcomes in the registry after 5 years. The ENGAGE registry includes a total of 1,263 patients with AAA enrolled from March 2009 to April 2011 at 79 centers across 30 countries. In April 2017, Philippe Cuypers, MD, first presented the 5-year data at the 2017 Charing Cross Symposium in London, United Kingdom.
As summarized in EJVES, the investigators noted that a significant proportion of the ENGAGE patients presented with challenging features, such as 15.2% with a AAA diameter > 7 cm, 12% with proximal neck lengths < 15 mm, and 10.2% with infrarenal neck angles > 60°. Of the 1,263 patients who were enrolled, 17.8% underwent implantation outside of the instructions for use for the device.
At 5-year follow-up, the Kaplan-Meier overall survival rate was 67.4%, and the freedom from aneurysm-related mortality was 97.8%. Freedom from aneurysm rupture, secondary procedures, and conversion to open repair at 5 years were 98.6%, 84.3%, and 97.9%, respectively. The 5-year freedom from type IA endoleak rate was 95.2% and freedom from type III endoleak rate was 97.4%. Aneurysm sac diameter at 5 years was observed to have either decreased ≥ 5 mm in diameter or remained stable in 89.4% of patients.
With follow-up expected through 10 years, the ENGAGE registry's 5-year data demonstrate sustained safety, effectiveness, and durability in this international cohort that is reflective of real-world experience, concluded the investigators in EJVES.