Comparison of self-expanding transcatheter heart valves for aortic stenosis: the multicentre, randomised, controlled, non-inferiority DOUBLE-CHOICE trial

Abstract

Background: Although withdrawn from the market, the specific design of the ACURATE neo2 valve might influence the design of future transcatheter aortic valve platforms.

Aims: We aimed to evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) using the ACURATE neo2 valve compared with the Evolut platform in selected anatomies.

Methods: In this investigator-initiated, 2x2 factorial, open-label, randomised, multicentre, non-inferiority trial, patients with symptomatic, severe aortic stenosis were randomised to the ACURATE neo2 or an Evolut PRO/PRO+/FX valve. The primary endpoint was a composite of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days. Non-inferiority of the ACURATE neo2 to an Evolut valve was tested in the intention-to-treat population (absolute non-inferiority margin of –6%, α of 0.05).

Results: At 10 sites in Germany, 835 patients were randomised. Within 30 days, the primary endpoint occurred in 60/389 patients (15.4%) in the ACURATE neo2 group and in 120/395 patients (30.4%) in the Evolut group (rate difference 15.0%, lower boundary of the 1-sided 95% confidence interval [CI]: 10.1%; p for non-inferiority<0.001, 2-sided 95% CI: 9.1-20.7; p for difference<0.001). A permanent pacemaker was implanted in 42/374 patients (11.2%) in the ACURATE neo2 group and in 101/381 patients (26.5%) in the Evolut group (p for difference <0.001). Rates of moderate/severe prosthetic valve regurgitation were low for both valves (1.3% vs 1.7%; p for difference=0.6).

Conclusions: In selected anatomies, TAVI with the ACURATE neo2 was non-inferior to TAVI with an Evolut valve, with significantly lower rates of the primary endpoint, driven by lower permanent pacemaker implantation at 30 days.