Valvular & structural heart diseaseCohort study
1-Year Outcomes of transcatheter aortic valve replacement (TAVR) With ACURATE neo2 vs SAPIEN/Evolut
- Registry-based target trial emulation
- nationwide
- balancing weighting adjustment
- Median follow-up 352 days (Q1-Q3: 193.5-365 days)
ACURATE neo2: predilatation 100%, postdilatation 45% (n = 288)
Authors' conclusion
There was no difference in clinical outcomes at 1 year between the ACURATE neo2 and the Evolut or SAPIEN valves.
Study context
- Population
- Patients undergoing TAVR in Sweden (SWEDEHEART registry), IDE trial inclusion and exclusion criteria
- Participants
- 644 vs 1,299
- Exposure
- TAVR with ACURATE neo2 vs SAPIEN or Evolut
- ACURATE neo2n = 644
- Controln = 1,299reference
- Outcome
- Mortality, stroke and HF hospitalization combined
- Follow-up
- 1 year
Main finding
As reported in the abstract
12 months
Adjusted hazard ratio
0.97
95% CI 0.75–1.23
ACURATE neo2 vs Control
adjusted HR 0.97 (95% CI 0.75–1.23)
Observational data: associations, not effects.
Further findings
Individual components, MI, percutaneous intervention · 12 months
- No difference between ACURATE neo2 and control
Postdilatation within ACURATE neo2
- Postdilatation not significantly associated with adverse outcomes
Safety
Major bleeding · 12 months
- No difference between ACURATE neo2 and control
Original publication
1-Year Outcomes of TAVR With ACURATE neo2 vs SAPIEN/Evolut. JACC Cardiovasc Interv. Published 24 November 2025. doi:10.1016/j.jcin.2025.09.025
Summarised from the published abstract; every number is checked against it