A global registry showed that men and women had equivalent outcomes after endovascular abdominal aortic aneurysm repair (EVAR) despite significant differences in baseline characteristics, anatomy, and off-instruction stent use.
The 5-year ENGAGE (Endurant Stent Graft Natural Selection Global Postmarket Registry) data were presented by Marc Schermerhorn, MD, chief, division of vascular and endovascular surgery, Beth Israel Deaconess Medical Center, Boston, in a late-breaking clinical trial at the Vascular Interventional Advances (VIVA) 2017 conference in Las Vegas.
The registry comprises data from 1,263 patients (133 women and 1,130 men) in 30 countries who received the Endurant II stent graft during for endovascular repair of the abdominal aortic aneurysm. ENGAGE participants are consecutively enrolled, and have 30-day and subsequent yearly evaluations, with independent data monitoring and event adjudication.
Dr. Marc Schermerhorn
Despite many other equivalent demographic and clinical characteristics, including smoking status, hypertension, diabetes, and pulmonary disease, overall women were statistically significantly older, had less cardiac disease, had shorter and more angulated aneurysm necks, and had smaller iliac arteries. In addition they were more likely to be treated outside of the Endurant II instructions for use (IFU), according to Dr. Schemerhorn.
Women also had significantly longer hospital stays than men (7.9 days vs. 6.4 days), respectively, but had equivalent procedure duration, ICU times, and similarly successful stent delivery and deployment (99%).
But despite these differences in baseline characteristics and anatomy, the 5-year data showed equivalent outcomes between women and men at 30 days, and 1 year, and through 5 years. There were no significant differences across these periods in freedom from all-cause mortality (67.5% in men, 65.6% in women, P = 0.87), 5-year freedom from aneurysm-related mortality (97.5% men, 100% women, P = .09), 5-year freedom from rupture (98.4% men, 100% women, P = .23), and 5-year freedom from conversion (97.8% men, 99.2% women, P = .48). There were also no significant differences in type 1 endoleaks, 5-year freedom from conversion, and sac diameter changes, Dr. Schermerhorn concluded.
The ENGAGE registry is sponsored by Medtronic. Dr. Schermerhorn disclosed that he was a consultant for several medical device companies and a shareholder and owner of a health care company, but that he did not have any potential conflicts of interest for this particular study.
mlesney@frontlinemedcom.com