Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis

Abstract

Background: There are few randomized trials comparing bioprostheses for transcatheter aortic valve replacement (TAVR), and no trials compared TAVR bioprostheses with supra-annular design. The SCOPE 2 trial was designed to compare the clinical outcomes of the ACURATE neo and CoreValve Evolut valves. Methods: SCOPE 2 was a randomized trial performed at 23 centers in 6 countries between April 2017 and April 2019. Patients ≥75 years with an indication for transfemoral TAVR as agreed by the Heart Team were randomly assigned to receive treatment with either the ACURATE neo (n=398) or the CoreValve Evolut bioprostheses (n=398). The primary endpoint, powered for non-inferiority of the ACURATE neo valve, was all-cause death or stroke at 1 year. The key secondary endpoint, powered for superiority of the ACURATE neo valve, was new permanent pacemaker implantation at 30 days. Results: Among 796 randomized patients (mean age 83.2±4.3 years; mean STS-PROM score 4.6± 2.9%), clinical follow-up information was available for 778 (98%) patients. Within 1 year, the primary endpoint occurred in 15.8% of patients in the ACURATE neo group and in 13.9% of patients in the CoreValve Evolut group (absolute risk difference 1.8%, upper one-sided 95% 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 -2.60, p=0.0027). No significant differences were observed in the components of the primary endpoint. Cardiac death at 30 days (2.8% vs. 0.8%, p=0.03) and 1 year (8.4% vs. 3.9%, p=0.01), and moderate or severe aortic regurgitation at 30 days (10% vs. 3%, p=0.002) were significantly increased in the ACURATE neo group. Conclusions: Transfemoral TAVR with the self-expanding ACURATE neo did not meet non-inferiority compared to the self-expanding CoreValve Evolut in terms of all-cause death or stroke at 1 year, and was associated with a lower incidence of new permanent pacemaker implantation. In secondary analyses, the ACURATE neo was associated with more moderate or severe aortic regurgitation at 30 days and cardiac death at 30 days and 1 year. Clinical Trial Registration: URL: https://clinicaltrials.gov/ Unique Identifier: NCT03192813.

The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes

“…ACU RAT E neo has demonstrated favorable clinical and echocardiographic outcomes, with low rates of mortality and PPI [10,11]. However, two recent investigator-initiated studies which randomized patients to ACU RAT E neo versus a later-generation competitor device (Sapien 3 and EvolutR/PRO) found a higher incidence of moderate or greater PVL in patients treated with ACU RAT E neo, which contributed to its missing the non-inferiority primary endpoints [12,13].…”

Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves

“…In the PARTNER 3 trial, among low surgical-risk patients, the rates of moderate or severe AR after TAVI with the balloon-expandable Sapien 3 transcatheter heart valve (THV)(Edwards Lifesciences, Irvine, CA, USA) at 30 days and at one year were similar to those after surgical aortic valve replacement [ 2 ]. In the SCOPE 2 trial [ 3 ], cardiac death at 30 days (2.8% vs. 0.8%; p = 0.03 for superiority) and 1 year (8.4% vs. 3.9%; p = 0.01 for superiority), and moderate or severe AR at 30 days (10% vs. 3%; p = 0.002 for superiority) were significantly increased in the ACURATE neo THV group compared to the Evolut THV series group. New generation THVs feature sealing skirts or incorporate outer pericardial wrap to minimize AR.…”

Transcatheter Aortic Valve Replacement in Young Low-Risk Patients With Severe Aortic Stenosis: A Review

“…Beside the progressive extension of TAVR to lower risk, younger populations, current research is focused on head to head comparisons between different transcatheter devices in order to ascertain the best fit between patient and current commercially available prostheses. Table 1 reports details on currently available direct comparisons between different devices (26)(27)(28)(29). The results of recent trials support the safe implantation of newer generation valves, which have the advantage of better adaptation to the individual valve anatomy (26).…”