Comparative Safety of TAVR With Self-Expanding vs Balloon-Expandable Bioprostheses

The SAPIEN 3 bioprosthesis for transcatheter aortic valve replacement (TAVR) is safer and more effective than the ACURATE neo in patients undergoing TAVR, according to recent study results published in The Lancet.

The researchers conducted a noninferiority trial to compare the balloon-expandable SAPIEN 3 TAVR system with the self-expanding ACURATE neo TAVR system. They compared baseline clinical characteristics and safety and efficacy endpoints between the two systems in a randomized sample of patients (N=739) undergoing transfemoral TAVR. The investigators evaluated the patients, all age ≥75 years across 20 centers in 4 European countries, within 30 days of treatment.

They treated patients with either the SAPIEN 3 (n=367) or the ACURATE neo (n=372) TAVR system. Within 30 days, 16% of patients from the SAPIEN 3 group and 24% from the ACURATE neo group reached the primary endpoint.

This difference (7.1%) did not meet the noninferiority threshold of 7.7% for the ACURATE neo system (P =.42). The SAPIEN 3 system was superior in the secondary analysis of primary endpoints, according to the superiority analysis (for risk difference: 95% CI, 1.3-12.9; P =.0156).

No difference was determined between the systems for incidence of all-cause death (P =.09) and stroke (P =.33). Both acute kidney injury and moderate or severe prosthetic aortic regurgitation were more common in the ACURATE neo group, but the differences were not statistically significant.

The researchers noted several limitations. First, the primary endpoints were composed of various clinical and echocardiographic parameters. Second, the study had limited power to show differences between individual endpoints. Third, the 30-day trial window does not allow evaluation of long-term clinical outcomes. Fourth, the CI and P values in the secondary analysis did not account for multiple testing. Fifth, the assessment of computed tomography scans was not performed at a central facility. Sixth, selection bias may have influenced the results. Finally, treatment masking was not possible in echocardiographic measurements.

The study authors concluded, “TAVR with the ACURATE neo did not meet noninferiority compared with the SAPIEN 3 device with respect to a composite safety and efficacy [endpoint] at 30 days. Differences in favor of the SAPIEN 3 TAVR system were driven by differences in the severity of paravalvular regurgitation and the frequency of stage [II] or [III] acute kidney injury.”

Disclosure: This study was supported by a grant from Boston Scientific. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Lanz J, Kim WK, Walther T, et al. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial [published online September 27, 2019]. Lancet. doi: 10.1016/S0140-6736(19)32220-2