Endologix Reports 1-Year Results From the LUCY Study
June 28, 2018—Endologix, Inc. announced that 1-year results from the LUCY registry were reported at the Society for Vascular Surgery's 2018 Vascular Annual Meeting held June 20–23 in Boston, Massachusetts.
The LUCY registry is evaluating outcomes of endovascular aneurysm repair (EVAR) with the company's Ovation abdominal stent graft system for abdominal aortic aneurysms (AAAs) in women. The background of the study is that women have more complex aortic anatomy and, subsequently, have worse reported outcomes than men undergoing EVAR.
The prospective, consecutively enrolling, nonrandomized, multicenter, postmarket LUCY registry enrolled a total of 225 patients, including 76 women in the treatment group and 149 men in the control group, at 39 sites in the United States. The primary endpoint of the study was the 30-day major adverse event rate. Secondary endpoints included serious and nonserious adverse events through 1 year.
According to the company, the results of the LUCY 1-year data expand on the 30-day results presented in 2017, showing that at least 28% more women are eligible for EVAR when using the Ovation abdominal stent graft system than when using other EVAR systems.
The 1-year LUCY data showed that despite having more complex anatomy at the time of the index procedure than men, women had similar outcomes to men after treatment with the ultra-low-profile (14-F) Ovation device. The freedom from AAA-related morality was 100% in women and 98.6% in men, freedom from reintervention for type 1a endoleak was 98.6% in women and 97.9% in men, freedom from rupture was 100% in both women and men, freedom from conversion was 100% in both women and men, and freedom from all device-related reintervention was 97.2% in both women and men.
Jennifer Ash, MD, who is Chairperson of the LUCY study advisory board, commented in the company's announcement, “Women have specific anatomical challenges in iliac access and proximal aortic neck morphology and have historically had worse outcomes from EVAR than men. The results of the LUCY study suggest that the unique features of the low-profile Ovation system may overcome these challenges and achieve similar outcomes in men and women.” Dr. Ash is with the Christie Clinic Vein and Vascular Center and is Assistant Clinical Professor of Surgery at University of Illinois College of Medicine in Champaign, Illinois.