ACURATE neo's (Boston Scientific) place in the treatment of severe aortic stenosis is unclear after failing to show noninferiority in a head-to-head comparison with another self-expanding, supra-annular transcatheter valve and reporting lackluster outcomes at 1 year in the SCOPE I trial.
The valve stumbled last year in SCOPE I when it did not establish noninferiority when compared with the balloon-expandable intra-annular Sapien 3 (Edwards Lifesciences) valve at 30 days.
In the SCOPE II trial, the ACURATE neo took on the self-expanding CoreValve Evolut (Medtronic) in 796 older adults (mean age, 83 years; 67.5% women) with symptomatic severe aortic stenosis (STS-PROM score, 4.6%).
The primary endpoint of all-cause death or any stroke at 1 year occurred in 15.8% of ACURATE neo patients and 13.9% of CoreValve patients in an intention-to-treat analysis (one-sided upper 95% confidence limit, 6.1%; P = .0549 for noninferiority).
In a per-protocol analysis, the primary endpoint occurred in 15.3% and 14.3%, respectively (one-sided upper 95% confidence limit 5.4%; P = .0314 for noninferiority).
The study could not claim noninferiority, however, because the protocol required both analyses to show noninferiority at a margin of 6%, explained Corrado Tamburino, MD, PhD, University of Catania, Italy.
The findings were presented in a late-breaking clinical trial session at the virtual meeting of Transcatheter Cardiovascular Therapeutics (TCT) 2020 and
