Valvular & structural heart diseaseRandomised controlled trial
Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial
- Randomised controlled trial
Authors' conclusion
Among low-risk patients aged ≤75 years with severe symptomatic AS, the rate of the composite of death, stroke, or rehospitalization at 1 year was similar between TAVI and surgery.
Study context
- Population
- Low-risk patients aged ≤75 years with severe symptomatic tricuspid or bicuspid aortic stenosis (AS)100 bicuspid AS
- Participants
- 370 patients
- Comparison
- Transcatheter aortic valve implantation (TAVI) vs surgery
- Primary endpoint
- Composite of:
- All-cause mortality
- Stroke
- Rehospitalization (procedure-, valve- or HF-related)
- Follow-up
- 12 months
Primary result
As reported in the abstract
1 year
Each group vs surgeryAbsolute risk difference (95% CI)
TAVI
3.1%(−2.7% to 8.8%)
Each group vs surgeryHazard ratio (95% CI)P value
TAVI
1.4(0.7–2.9)
P = 0.3Further findings
| Outcome | TAVI | Surgery | HR (95% CI) | |
|---|---|---|---|---|
| Primary composite, by valve anatomy (subgroup) · tricuspid AS | 8.7% | 8.3% | 1.0 (0.5–2.3) | |
| Primary composite, by valve anatomy (subgroup) · bicuspid AS | 14.3% | 3.9% | 3.8 (0.8–18.5) | |
| 0.050.21520Hazard ratio (log scale) |
- Primary composite, by valve anatomy (subgroup): P for interaction = .1
Safety
Procedural complications
- Lower risk of major bleeding and new-onset AF with TAVI vs surgery
- Higher risk of non-disabling stroke, permanent pacemaker implantation and moderate or greater paravalvular regurgitation with TAVI vs surgery
Original publication
Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial. Eur Heart J. Published 15 May 2024. doi:10.1093/eurheartj/ehae331
Summarised from the published abstract; every number is checked against it