Valvular & structural heart diseaseRandomised controlled trial
Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial
- Randomised controlled trial
- multicentre
- international
- 15 university hospitals
Authors' conclusion
In patients with severe aortic stenosis and SAA (women in the majority), there was no evidence of superiority of contemporary TAVR versus SAVR in valve hemodynamic results. After a median follow-up of 2 years, there were no differences in clinical outcomes between groups.
Study context
- Population
- Severe AS and small aortic annulus (mean diameter <23 mm)140 (93%) women
- Participants
- 151 participants
- Comparison
- Transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR)
- TAVRn = 77
- SAVRn = 74reference
- Primary endpoint
- Impaired valve hemodynamics (severe prosthesis patient mismatch or moderate-severe aortic regurgitation) by Doppler echocardiography, central core laboratory
- Follow-up
- 60 days
Primary result
As reported in the abstract
| Group | Value | Moderate-severe aortic regurgitation |
|---|---|---|
| TAVR | 5.6% | 0 |
| SAVR | 10.3% | 0 |
- TAVR vs SAVR: P = 0.30 — severe prosthesis patient mismatch
Secondary outcomes
Mortality · 30 days
P = 1.00
Mortality · median follow-up 2 (IQR 1-4) years
P = 0.89
Stroke · median follow-up 2 (IQR 1-4) years
P = 0.95
Cardiac hospitalization · median follow-up 2 (IQR 1-4) years
P = 0.80
| Outcome | TAVR | SAVR | P value |
|---|---|---|---|
| Stroke · 30 days | 0 events | 2.7% | P = 0.24 |
Original publication
Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial. Circulation. Published 26 October 2023. doi:10.1161/circulationaha.123.067326
Summarised from the published abstract; every number is checked against it