Randomised controlled trial
Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial
- Randomised controlled trial
- 10-year follow-up
Authors' conclusion
In patients with severe AS and lower surgical risk randomized to TAVI or SAVR, the risk of major clinical outcomes was not different 10 years after treatment. The risk of severe bioprosthesis SVD was lower after TAVR compared with SAVR, while the risk of BVF was similar.
Study context
- Population
- Patients with severe AS at lower surgical risk
- Participants
- 280 patients
- Comparison
- Transcatheter aortic valve implantation (TAVI) vs surgical aortic valve replacement (SAVR)
- TAVIn = 145
- SAVRn = 135reference
- Primary endpoint
- Composite of:
- All-cause mortality
- Stroke
- MI
- Follow-up
- 10 years
Primary result
All-cause mortality, stroke or MI
Hazard ratio
1.0
95% CI 0.7–1.3
P = 0.9
By group
TAVI vs SAVR
HR 1.0 (95% CI 0.7–1.3); P = 0.9
As reported in the abstract
Further findings
| Outcome | TAVI | SAVR | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Severe SVD · 10 years | 1.5% | 10.0% | 0.2 (0.04–0.7) | P = 0.02 | |
| Bioprosthetic valve failure · 10 years | 9.7% | 13.8% | 0.7 (0.4–1.5) | P = 0.4 | |
| 0.050.21520Hazard ratio (log scale) |
Severe NSVD (cumulative incidence) · 10 years
P < 0.001
Safety
Endocarditis (cumulative incidence) · 10 years
P = 1.0
Clinical valve thrombosis · 10 years
- No patients had clinical valve thrombosis
Original publication
Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial. Eur Heart J. Published 7 February 2024. doi:10.1093/eurheartj/ehae043
Summarised from the published abstract; every number is checked against it