Findings of the SCOPE II clinical trial, which were presented during a late breaking trial session at TCT Connect 2020 (14–18 October, virtual), have shown that the Acurate neo (Boston Scientific) transcatheter aortic valve failed to demonstrate non-inferiority compared to the CoreValve Evolut (Medtronic) valve. The findings were presented by Corrado Tamburino (University of Catania, Catania, Italy) and were simultaneously published in Circulation.
According to Tamburino, the two valves differed with respect to technical characteristics such as degree of aortic regurgitation as well as the need for new permanent pacemaker implantation.
SCOPE II enrolled a total of 796 patients aged 75 years or older with symptomatic severe aortic stenosis and indication for transfemoral transcatheter aortic valve implantation (TAVI) from 23 tertiary heart centres in Denmark, France, Germany, Italy, Spain and the UK. Participants were randomly assigned (1:1) to receive either the Acurate neo or CoreValve Evolut devices.
The primary safety endpoint, powered for non-inferiority of the Acurate neo valve using a non-inferiority margin of 6%, was the composite of all-cause mortality or stroke at 12 months. The primary efficacy endpoint, powered for superiority, was new permanent pacemaker implantation at 30 days. Secondary endpoints included clinical efficacy and safety endpoints at 30 days and 12 months.
In the intention-to-treat analysis, death or stroke at one year was 15.8% in the Acurate neo group compared to 13.9% in the CoreValve Evolut group, while in the per-protocol analysis it was 15.3% vs. 14.3%. Non-inferiority of the Acurate neo was not met for the primary endpoint in the intent-to-treat analysis, while it was met in the per-protocol analysis. Based on the pre-specified statistical plan, due to these inconsistent results, non-inferiority was not established for the primary endpoint.
New pacemaker implantation at 30 days was 10.5% with Acurate neo compared to 18% with CoreValve Evolut (Risk Difference -7.5%, 95% CI -12.4–-2.60, p= 0.0027). Cardiac death at 30 days (2.8% vs 0.8%, p=0.03) and one year (8.4% vs 3.9%, p=0.01) was greater in the Acurate neo group. The rate of moderate-severe aortic regurgitation was 9.6% vs 2.9% (P<0.0001) at 30 days and 4% vs. 3.3% (P<0.0001) at one year.
“TAVI with the Acurate neo valve did not meet non-inferiority compared with the CoreValve Evolut bioprosthesis with respect to a composite of death or stroke at one year,” said Tamburino. “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.”
