ACURATE neo Valve Fails to Demonstrate NonInferiority vs CoreValve Evolut in SCOPE II

Corrado Tamburino, MD, PhD

Results of the SCOPE II trial indicate ACURATE neo valves failed to demonstrate non-inferiority when compared head-to-head against CoreValve Evolut valves in a randomized clinical trial.

The study, which was presented at Transcatheter Cardiovascular Therapies (TCT) Connect 2020, examined use of the self-expanding, supra-annular valve from Boston Scientific in a cohort of more than 750 patients across 23 medical centers in 6 countries.

"TAVR with the ACURATE neo valve did not meet noninferiority compared with the CoreValve Evolut bioprosthesis with respect to a composite of death or stroke at one year," said Corrado Tamburino, MD, PhD, Division of Cardiology at C.A.S.T. Policlinico at the University of Catania, in Italy, in a statement from the Cardiovascular Research Foundation. "In a secondary analysis with limited statistical power, cardiac death was increased at one year in patients who received the ACURATE neo valve. The two valves also differed with respect to technical characteristics such as degree of aortic regurgitation and need for new permanent pacemaker implantation."

The SCOPE II trial was designed to study further the safety and efficacy of the ACURATE neo valve by comparing it to the CoreValve Evolut R from Medtronic Inc., which received initial approval from the US Food and Drug Administration in 2015. Designed as a multicenter, randomized, parallel-design, non-inferiority, open-label trial, the study enrolled patients 75 years or older with symptomatic severe aortic stenosis at increased risk for mortality with conventional surgical aortic valve replacement.

In total, 796 patients were randomized in a 1:1 ratio between April 2017-April 2019, of which 98% had follow-up information related to the primary end point and were included in the intention-to-treat analysis.

The primary end point of the study was a composite of all-cause death or any stroke at 1 year and a key secondary end point of new permanent pacemaker implantation at 30 days. Other secondary end points for the study included individual components of the primary endpoint at 30 days and 1 year, procedural complications, clinical safety endpoints, composite endpoints as defined by the Valve Academic Research Consortium (VARC)-2, and bioprosthesis function as assessed by echocardiography. Of note, all end point related adverse events were adjudicated by an independent committee.

Upon analysis, results indicated the primary end point occurred in 15.8% of patients randomized to the ACURATE neo group and in 13.9% of the CoreValve Evolut group (absolute risk difference 1.8%, upper one-sided 95% confidence limit 6.1%, P=.0549 for noninferiority). For 30-day pacemaker implementation, results indicated implementation occurred in 10.5% of the ACURATE neo group and 18.0% of the CoreValve Evolut group (absolute risk difference -7.5%; 95%CI, -12.4 to -2.60; P=.0027).

Additional findings from the analysis included significantly increased rates of cardiac death at 30 days (2.8% vs 0.8%, P=.03) and 1 year (8.4% vs 3.9%; P=.01) and moderate or severe aortic regurgitation at 30 days (10% vs 3%, P=.002) among those in the ACURATE neo group. Investigators noted there were no significant differences when assessing the individual components of the primary end point.

This study, “Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients with Symptomatic Severe Aortic Stenosis: The SCOPE 2 Randomized Clinical Trial,” was presented at TCT Connect 2020 and simultaneously published in Circulation.