Outcomes With 2 Self-Expanding Bioprostheses in TAVR for Symptomatic Severe Aortic Stenosis

transcatheter aortic valve implantation (replacement) is an investigational treatment for severe aortic stenosis
Outcomes of transfemoral TAVR for symptomatic severe aortic stenosis were comparable with the self-expanding transcatheter ACURATE neo valve or the CoreValve Evolut valve.

Outcomes of transfemoral transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis were comparable with the self-expanding transcatheter ACURATE neo valve or the CoreValve Evolut valve, according to a study published in Circulation.

In the randomized Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II study (ClinicalTrials.gov Identifier: NCT03192813), 796 patients (ages, ≥75 years; mean age, 83.2±4.3 years) with symptomatic severe aortic stenosis and an indication for transfemoral TAVR were enrolled from 23 centers across 6 countries.

Study participants were randomly assigned to receive TAVR with the ACURATE neo (n=398) or the CoreValve Evolut bioprosthesis (n=398). The study’s primary endpoint was a composite of all-cause death or stroke at 1 year. This endpoint was powered for non-inferiority of the ACURATE neo valve. The incidence of a new permanent pacemaker implantation at 30 days was the secondary endpoint, which was powered for superiority of the ACURATE neo valve.

At the 1-year follow up, the primary composite endpoint in the intention-to-treat cohort occurred in 15.8% and 13.9% of patients assigned to receive an ACURATE neo and a CoreValve Evolut valve, respectively (absolute risk difference, 1.8%; upper one-sided 95% confidence limit, 6.1%; P =.0549 for noninferiority).

In the per-protocol analysis, a higher incidence of the primary composite endpoint occurred in the ACURATE neo group (15.3%) vs the CoreValve Evolut group (14.3%; absolute risk difference, 1.0%; 1-sided upper 95% confidence limit, 5.4%; P =.0314 for noninferiority; and P =.70 for superiority). Noninferiority of the ACURATE neo valve could not be established for the primary endpoint due to inconsistent findings between the intention-to-treat and per-protocol analyses.

Treatment with the ACURATE neo vs CoreValve Evolut valve was associated with a lower 30-day rate of new permanent pacemaker implantation (10.5% vs 18.0%, respectively; absolute risk difference, -7.5%; 95% CI, -12.4 to -2.60; P =.0027).

Patients receiving the ACURATE neo vs CoreValve Evolut valve had higher rates of cardiac death at 30 days (2.8% vs 0.8%, respectively; P =.03) and 1 year (8.4% vs 3.9%, respectively; P =.01) as well as higher rates of moderate or severe aortic regurgitation at 30 days (10% vs 3%, respectively; P =.002).

Limitations of the study include the relatively short follow-up period (1-year) as well as the lack of analytical power to identify significant differences in individual endpoints between the 2 valves.

“[T]he valves implanted in the ACURATE neo group had smaller average diameters… [which may] explain the higher incidence of paravalvular aortic regurgitation in the ACURATE neo group despite more frequent postdilatation as compared [with] the CoreValve Evolut group,” noted the study authors.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Tamburino C, Bleiziffer S, Thiele H, et al. Comparison of self-expanding bioprostheses for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: The SCOPE 2 randomized clinical trial. Published online October 15, 2020. Circulation. doi:10.1161/CIRCULATIONAHA.120.051547