- Question
- Is the ACURATE neo2 valve non-inferior to commercially available transcatheter heart valves (SAPIEN 3 or Evolut) in patients with severe symptomatic aortic stenosis?
- Design
- Multicentre, randomised 1:1, controlled, non-inferiority trial with a Bayesian analysis, conducted at 71 centres in the USA and Canada; 1500 patients were randomised (752 to ACURATE neo2 and 748 to control), with 1-year follow-up.
- Population
- Patients with severe symptomatic aortic stenosis at any level of surgical risk; median age 79 years and 51.9% female.
- Intervention
- TAVR with the ACURATE neo2 valve, a self-expanding, supra-annular, open-cell valve, implanted per the manufacturer's instructions.
- Control
- TAVR with a commercially available control valve: SAPIEN 3 (or SAPIEN 3 Ultra) or Evolut.
- Primary outcome
- Composite of all-cause mortality, all stroke and rehospitalisation at 1 year, with a non-inferiority margin of 8.0%.
- Results
- Non-inferiority was not met: the posterior median probability of the primary endpoint was 16.2% with ACURATE neo2 vs 9.5% with control (difference 6.6%; 95% credible interval 3.0-10.2). By Kaplan-Meier, the composite was 14.8% vs 9.1% (HR 1.71; 95% CI 1.26-2.33; p=0.0005).
- Safety
- With ACURATE neo2, cardiovascular mortality (3.7% vs 1.8%), spontaneous myocardial infarction (2.4% vs 0.7%) and prosthetic valve aortic regurgitation, both mild (42.5% vs 24.8%) and moderate (4.4% vs 1.8%), were more frequent at 1 year.
- Conclusion
- In severe symptomatic aortic stenosis, TAVR with ACURATE neo2 did not meet non-inferiority and had worse outcomes than commercial valves on the 1-year composite endpoint.
- Why it matters
- This was the first randomised trial of this valve and showed that it does not deliver outcomes equivalent to established platforms, underscoring the need to validate each TAVR device in comparative trials before broad use.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026