Valvular & structural heart diseaseRandomised controlled trial
Comparison of self-expanding transcatheter heart valves for aortic stenosis: the multicentre, randomised, controlled, non-inferiority DOUBLE-CHOICE trial
- investigator-initiated, 2x2 factorial, open-label, randomised, multicentre, non-inferiority trial
- 10 sites in Germany
Authors' conclusion
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.
Study context
- Population
- Patients with symptomatic, severe aortic stenosis in selected anatomiespatients randomised
- Participants
- 835 patients
- Comparison
- Transcatheter aortic valve implantation (TAVI) using the ACURATE neo2 valve compared with the Evolut platform
- Primary endpoint
- Composite of:
- All-cause mortality
- Stroke
- Moderate/severe prosthetic valve regurgitation
- Permanent pacemaker implantation
- Follow-up
- 30 days
Primary result
As reported in the abstract
ACURATE neo2 group vs Evolut groupRate difference (2-sided 95% CI)P value
lower rate with ACURATE neo2
15.0%(9.1–20.7)
P < 0.001for difference- lower boundary of the 1-sided CI; lower rate with ACURATE neo2
- rate difference 15.0% (1-sided 95% CI 10.1%); P for non-inferiority < 0.001
Further findings
Permanent pacemaker implantation · 30 days
P for difference < 0.001
Moderate/severe prosthetic valve regurgitation
P for difference = 0.6
Original publication
Comparison of self-expanding transcatheter heart valves for aortic stenosis: the multicentre, randomised, controlled, non-inferiority DOUBLE-CHOICE trial. EuroIntervention. Published 15 May 2026. doi:10.4244/eij-d-26-00001
Summarised from the published abstract; every number is checked against it