Valvular & structural heart diseaseRandomised controlled trial
Transcatheter or Surgical Treatment of Aortic-Valve Stenosis
- Randomised controlled trial
- non-inferiority
- 38 sites in Germany
Authors' conclusion
Among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at 1 year.
Study context
- Population
- Patients with severe AS at low or intermediate surgical risk
- Participants
- 1,414 patients
- Comparison
- Transcatheter aortic-valve implantation (TAVI) vs surgical aortic-valve replacement (SAVR)
- TAVIn = 701
- SAVRn = 713reference
- Primary endpoint
- Composite of death from any cause or fatal or nonfatal stroke
- Follow-up
- 1 year
Primary result
As reported in the abstract
Death from any cause or stroke (Kaplan-Meier estimate)
Hazard ratio
0.53
95% CI 0.35–0.79
P < 0.001 for non-inferiority
By group
TAVI vs SAVR
HR 0.53 (95% CI 0.35–0.79); P for non-inferiority < 0.001
Further findings
| Outcome | TAVI | SAVR | HR (95% CI) | |
|---|---|---|---|---|
| Death from any cause | 2.6% | 6.2% | 0.43 (0.24–0.73) | |
| Stroke | 2.9% | 4.7% | 0.61 (0.35–1.06) | |
| 0.20.5125Hazard ratio (log scale) |
Safety
Procedural complications
Original publication
Transcatheter or Surgical Treatment of Aortic-Valve Stenosis. N Engl J Med. Published 8 April 2024. doi:10.1056/nejmoa2400685
Summarised from the published abstract; every number is checked against it