The Acurate neo transcatheter heart valve failed to establish noninferiority to the CoreValve Evolut valves at 1 year after transcatheter aortic valve replacement (TAVR), according to study results presented Thursday at the TCT Connect virtual conference.
Corrado Tamburino, MD, PhD, of the University of Catania, Italy, presented the data from the SCOPE II randomized controlled trial at TCT. A manuscript reporting the results was simultaneously published online in Circulation.
The trial randomly assigned patients to receive either an Acurate neo (Boston Scientific) or CoreValve Evolut R or Pro (Medtronic) valve for TAVR. A total of 796 patients across six European countries were enrolled and followed for 1 year. Both valves feature a similar supra-annular design designed to improve hemodynamics. The trial was powered for non-inferiority, and the primary endpoint was a composite of all-cause death or stroke at 1 year. A key secondary endpoint of new permanent pacemaker insertion at 30 days.
In the intention-to-treat analysis, at 1 year, the primary endpoint occurred in 15.8% of patients in the Acurate neo group compared to 13.9% of patients in the CoreValve Evolut group (absolute risk difference, 1.8%; one-sided 95% upper confidence limit, 6.1%; p=0.0549 for noninferiority). The 30-day rates of new permanent pacemaker implantation were 10.5% in the Acurate neo group and 18.0% in the CoreValve Evolut group (absolute risk difference, -7.5%; 95% confidence interval, -12.4 to -2.6; p=0.0027). Cardiac death (at 30 days and 1 year) and moderate or severe aortic regurgitation (at 30 days) were more frequent in patients randomized to the Acurate neo valve.
Tamburino and colleagues called for further design improvements to the Acurate neo to mitigate the risk of paravalvular regurgitation and improve clinical terms in the short and midterm.
The SCOPE II trial was sponsored by the Center for European Research Initiatives in Cardiovascular Medicine with grant support from Symetis SA.