- Question
- Is the ACURATE neo2 valve non-inferior to the Evolut platform in patients with symptomatic severe aortic stenosis and selected anatomies undergoing TAVI?
- Design
- Investigator-initiated, open-label, randomised, multicentre, non-inferiority trial with a 2x2 factorial design, conducted at 10 sites in Germany with 835 randomised patients.
- Population
- Patients with symptomatic severe aortic stenosis and selected anatomies undergoing transcatheter aortic valve implantation.
- Intervention
- TAVI with the self-expanding ACURATE neo2 valve.
- Control
- TAVI with an Evolut valve (PRO, PRO+ or FX).
- Primary outcome
- 30-day composite of all-cause mortality, stroke, moderate/severe prosthetic valve regurgitation and permanent pacemaker implantation. Non-inferiority was tested in the intention-to-treat population with an absolute margin of -6%.
- Results
- The primary endpoint occurred in 60/389 patients (15.4%) with ACURATE neo2 and 120/395 (30.4%) with Evolut (rate difference 15.0%; lower boundary of the 1-sided 95% CI 10.1%; p for non-inferiority <0.001; 2-sided 95% CI 9.1-20.7; p for difference <0.001). Permanent pacemaker was implanted in 42/374 (11.2%) vs 101/381 (26.5%) (p <0.001).
- Safety
- Moderate/severe prosthetic valve regurgitation was low in both groups (1.3% vs 1.7%; p=0.6).
- Conclusion
- In selected anatomies, TAVI with ACURATE neo2 was non-inferior to Evolut, with a lower primary endpoint rate driven by fewer pacemaker implantations at 30 days.
- Why it matters
- It showed that the specific design of the ACURATE neo2 valve, although withdrawn from the market, can reduce the need for pacemakers and may inform the design of future TAVI platforms.
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