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.
LVEF improves after TAVI for treatment of severe aortic stenosis in patients without new conduction defects. In patients with a new conduction defect after TAVI, there is no improvement in LVEF at follow-up.
Apical LV function abnormalities can be detected at 3-month follow-up in all TA-TAVI patients using CMR-FT. TA-TAVI results in significant impairment of apical LV function compared with TF-TAVI.
There is only a moderate correlation between aortic root angiography and CMR in the classification of AR severity after TAVI. Alternative imaging including multimodality imaging as well as haemodynamic analysis should therefore be considered for intraprocedural AR assessment and guidance of TAVI procedure in cases of uncertainty in AR grading.
In patients referred for TAVI, aortic valve calcification severity and impaired left ventricular function may serve as a predictor of long-term mortality. Therefore, AVC scores easily determined from pre-procedural CT datasets may be used for patient risk stratification.
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