12 Month Outcomes From The Ovation Alto Pivotal Trial
Sean P. Lyden, MD.
Cleveland Clinic Foundation, Cleveland, OH, USA.
OBJECTIVE -The Alto Abdominal Stent Graft System is an investigational stent graft for treatment of infrarenal abdominal aortic aneurysm (AAA) designed to fill an unmet need by accommodating the widest range of anatomies. The primary endpoint of this investigational device exemption (IDE) study (ELEVATE; NCT02949297) was to evaluate treatment success at 12 months in patients with AAA treated with Alto relative to a performance goal of 80%. METHODS -Patients were eligible for enrollment if they were 18 years or older, gave informed consent and had an infrarenal AAA with one or more of the following characteristics: ≥5.0 cm in diameter, aneurysm size increased by 0.5 cm in last 6 months, maximum diameter of aneurysm exceeded 1.5 times the transverse dimension of an adjacent normal aortic segment. Patients were implanted with Alto devices and followed for 30-days, 6 months, and 1-year by clinical evaluation and CT imaging. Treatment success was defined as technical success and freedom from AAA enlargement, migration, type I or III endoleak, AAA rupture, or surgical conversion, stent graft stenosis, occlusion, kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months. Adverse events (AEs) were adjudicated by an independent Clinical Evaluation Committee. A sample size of 60 evaluable patients was required at one year to meet the statistical power requirement of the formal endpoint. Clinical data were analyzed using SAS version 9.4. RESULTS -Of the 140 patients screened, 75 were enrolled (73 y; 93% male) from March 2017 to February 2018. The 30 day MAE rate was 5.3%. At one year, the treatment success rate was 96.7% among 61 evaluable patients. Through 1 year post-treatment, all-cause mortality was 4.0%. No AAA-related mortality occurred. AAA enlargement was 1.6%, type I endoleak rate was to 1.4%, with 100% freedom from type III endoleaks, device migration, device fracture, stent occlusion, or AAA rupture. The device-related secondary intervention rate was 2.7%. CONCLUSIONS -.The treatment success rate of 96.7% and 5.3% 1 month MAE rate demonstrates that endovascular repair of AAA with the Alto device yields a favorable effectiveness profile through 1 year post-treatment patients with AAA and the appropriate vascular anatomy.
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