Key result
ACURATE neo2 matches Evolut, halving 30-day major composite outcomes in TAVI to ~15%.
Why the study?
Although withdrawn from the market, the design of the ACURATE neo2 valve might influence future transcatheter aortic valve platforms, prompting evaluation of its safety and efficacy compared with the Evolut platform.
Does TAVI with the ACURATE neo2 valve reduce the composite of mortality, stroke, regurgitation, and pacemaker implantation compared to the Evolut platform in patients with symptomatic severe aortic stenosis?
RCT (n=835)
open-label
2x2 factorial
Yes
Does TAVI with the ACURATE neo2 valve reduce the composite of mortality, stroke, regurgitation, and pacemaker implantation compared to the Evolut platform in patients with symptomatic severe aortic stenosis?
Absolute Risk Reduction: 15 (95% CI 9.1–20.7)
Absolute Event Rate: 15.4% vs 30.4%
Absolute Risk Reduction: 15%
p-value: p=<0.001 for non-inferiority
In patients with severe aortic stenosis, TAVI with the ACURATE neo2 valve was non-inferior and superior to the Evolut platform for a 30-day composite endpoint, primarily driven by a lower need for permanent pacemaker implantation.
No takes yet. Share an insight, caveat, or question.
May reduce pacemaker needs in selected anatomies; leaves open preference over Evolut pending larger confirmatory trials.
Feistritzer et al. (2026) conducted an RCT in symptomatic, severe aortic stenosis (n=835). ACURATE neo2 valve vs. Evolut PRO/PRO+/FX valve was evaluated on composite of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30 days (rate difference 15.0%, 95% CI 9.1-20.7, p=<0.001 for non-inferiority). TAVI with the ACURATE neo2 valve was non-inferior to the Evolut platform for the 30-day composite primary endpoint (15.4% vs 30.4%; rate difference 15.0%, 95% CI 9.1-20.7; P<0.001 for non-inferiority).
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