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