Valvular & structural heart diseaseRandomised controlled trial
ACURATE neo2 valve versus commercially available transcatheter heart valves in patients with severe aortic stenosis (ACURATE IDE): a multicentre, randomised, controlled, non-inferiority trial
- Randomised controlled trial
- multicentre
- non-inferiority
- Bayesian primary analysis
Authors' conclusion
In patients with symptomatic severe aortic stenosis, TAVR with ACURATE neo2 did not meet non-inferiority and resulted in significantly worse outcomes with respect to the primary endpoint of composite of all-cause mortality, all stroke, and rehospitalisation at 1 year when compared with commercial valves.
Study context
- Population
- Patients with symptomatic severe AS and any level of surgical risk, 71 centres in the US and Canada
- Participants
- 1,500 patients
- Comparison
- Transcatheter aortic valve replacement (TAVR) with ACURATE neo2 vs commercially available valves
- ACURATE neo2n = 752
- Controln = 748reference
- Primary endpoint
- Composite of:
- All-cause mortality
- All stroke
- Rehospitalisation (non-inferiority margin 8.0%)
- Follow-up
- 1 year
Primary result
As reported in the abstract
Composite of:
- All-cause mortality
- Stroke
- Rehospitalisation (posterior median probability)
Between-group difference
6.6%
95% CrI 3.0–10.2
By group
ACURATE neo2 vs Control
between-group difference 6.6% (95% CrI 3.0–10.2)
Non-inferiority margin 8 as printed, not drawn
- Upper bound exceeded non-inferiority margin of 8%; non-inferiority not met; posterior probability of treatment difference
- >0.999
Further findings
| Outcome | ACURATE neo2 | Control | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Composite endpoint, Kaplan-Meier rates · 1 year | Kaplan-Meier rate 14.8% (95% CI 12.5–17.6) | Kaplan-Meier rate 9.1% (95% CI 7.2–11.4) | 1.71 (1.26–2.33) | P = 0.0005 | |
| All-cause mortality · 1 year | 36 events | 28 events | 1.30 (0.80–2.14) | ||
| Stroke · 1 year | 41 events | 25 events | 1.68 (1.02–2.75) | ||
| Rehospitalisation · 1 year | 38 events | 25 events | 1.57 (0.95–2.61) | ||
| 0.20.5125Hazard ratio (log scale) |
CV mortality
P = 0.024
Safety
Spontaneous MI · 1 year
P = 0.0092
Prosthetic valve aortic regurgitation (central plus paravalvular) · 1 year
Mild
Moderate
Severe
- Prosthetic valve aortic regurgitation (central plus paravalvular): mild p<0.0001
- Prosthetic valve aortic regurgitation (central plus paravalvular): moderate p=0.0070
- Prosthetic valve aortic regurgitation (central plus paravalvular): severe p=0.12
Original publication
ACURATE neo2 valve versus commercially available transcatheter heart valves in patients with severe aortic stenosis (ACURATE IDE): a multicentre, randomised, controlled, non-inferiority trial. Lancet. Published 21 May 2025. doi:10.1016/s0140-6736(25)00319-8
Summarised from the published abstract; every number is checked against it