Five-Year Gender Subset Data Presented From Medtronic's ENGAGE Registry
September 13, 2017—Medtronic announced that 5-year ENGAGE global registry data for the company's Endurant II abdominal aortic aneurysm stent graft system were presented by Marc Schermerhorn, MD, in a late-breaking clinical trial at the VIVA 17, Vascular Interventional Advances, conference held September 11–14 in Las Vegas, Nevada.
According to the company, the Endurant II device continues to demonstrate long-term durability and consistent outcomes in a real-world setting among both male and female patients treated with endovascular aneurysm repair (EVAR).
Dr. Schermerhorn commented in Medtronic's press release, “It is well known in the clinical community that women have not benefited to the same extent as men when receiving an EVAR procedure, and in turn, have become a greatly underserved patient population. Endurant is now the only stent graft system to close the outcomes gap between men and women at 30 days, 1 year, and 5 years, which sets a new benchmark for EVAR device performance and has the potential to change the treatment paradigm for female patients.”
As summarized by Medtronic, the 5-year gender subset analysis of the ENGAGE global registry included 1,263 patients (133 female and 1,130 male). The study population was composed of females with an average age of 75.7 years and with smaller diameter proximal necks and narrower access vessels. Approximately 16.5% of females compared to 11.5% of males had proximal neck lengths < 15 mm and 19.7% of females compared to 9% of males had infrarenal neck angles of > 60º. The data underscore previous findings between men and women at 30 days and 1 year, which demonstrated consistent efficacy and safety.
Dr. Schermerhorn reported a successful delivery and deployment rate of 99.2% in the female cohort compared to 99.5% in the male cohort (P = .746).
At 5 years, the study showed consistency between genders: freedom from aneurysm-related mortalities (ARM) in females of 100% compared to 97.55% in males (P = .0881); observed type Ia endoleaks in 3.8% of females compared to 1.3% of males (P = .197); freedom from secondary procedures of 85.6% in females compared to 84.1% in males (P = .515); the aneurysm sac remained stable or decreased in 89.6% of females compared to 89.4% of males; and freedom from rupture rate in females of 100% compared to a 98.4% in males (P = .2263).
The Endurant system received European CE Mark approval in June 2008 and US Food and Drug Administration approval in December 2010.
The ENGAGE postmarket registry, which is being conducted at 79 sites in 30 countries, was initiated less than 1 year after the Endurant device received CE Mark approval and will have clinical follow-up out to 10 years. The goal of ENGAGE is to gather evidence in a real-world patient population, including patients with challenging anatomy who have historically been difficult to treat, and are associated with limited eligibility for endovascular repair and higher rates of secondary interventions, stated Medtronic.
Outside the United States, the Endurant stent graft system is approved for use in patients with abdominal aortic aneurysm neck lengths ≥ 10 mm and infrarenal angulation ≤ 60° and neck lengths ≥ 15mm with infrarenal angulation ≤ 75°. In the United States, the Endurant stent graft system is indicated for necks ≥ 10 mm and infrarenal angulation ≤ 60°.