Valvular & structural heart diseaseRandomised controlled trial
Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement
- Randomised controlled trial
- multicentre (57 centres)
- stratified by intended transfemoral or transthoracic access
Authors' conclusion
Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement.
Study context
- Population
- Intermediate-risk patients with severe, symptomatic AS
- Participants
- 2,032 patients
- Comparison
- Transcatheter aortic-valve replacement (TAVR) vs SAVR
- Primary endpoint
- Death from any cause or disabling stroke
- Follow-up
- 5 years
Primary result
As reported in the abstract
Hazard ratio
1.09
95% CI 0.95–1.25
P = 0.21
By group
TAVR vs Surgery
HR 1.09 (95% CI 0.95–1.25); P = 0.21
Further findings
| Outcome | TAVR | Surgery | HR (95% CI) | |
|---|---|---|---|---|
| Death or disabling stroke, transfemoral-access cohort (subgroup) · 5 years | 44.5% | 42.0% | 1.02 (0.87–1.20) | |
| Death or disabling stroke, transthoracic-access cohort (subgroup) · 5 years | 59.3% | 48.3% | 1.32 (1.02–1.71) | |
| 0.512Hazard ratio (log scale) |
Health status improvement · 5 years
- Similar for TAVR and surgery
Safety
At least mild paravalvular aortic regurgitation · 5 years
Repeat hospitalizations
Aortic-valve reinterventions
Original publication
Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. Published 29 January 2020. doi:10.1056/nejmoa1910555
Summarised from the published abstract; every number is checked against it