Valvular & structural heart diseaseRandomised controlled trial
Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis
- Randomised controlled trial
- multicentre
- 75 centres in the US and Canada
- 1:1 randomisation
- superiority
Authors' conclusion
Among patients with asymptomatic severe aortic stenosis, a strategy of early TAVR was superior to clinical surveillance in reducing the incidence of death, stroke, or unplanned hospitalization for cardiovascular causes.
Study context
- Population
- Patients with asymptomatic severe AS
- Participants
- 901 patients
- Comparison
- Early transcatheter aortic-valve replacement (TAVR) vs clinical surveillance
- TAVRn = 455
- Clinical surveillancen = 446reference
- Primary endpoint
- Composite of:
- Death
- Stroke
- Unplanned hospitalization for CV causes
Primary result
As reported in the abstract
Hazard ratio
0.50
95% CI 0.40–0.63
P < 0.001
Events by treatment group
TAVR vs Clinical surveillance
HR 0.50 (95% CI 0.40–0.63); P < 0.001
Further findings
Components of the primary end point
Death
Stroke
Unplanned hospitalization for CV causes
- Aortic-valve replacement in the clinical surveillance group · median follow-up 3.8 years
- 87.0%
Safety
Procedure-related adverse events
- No apparent differences between TAVR and surveillance patients who underwent aortic-valve replacement
Original publication
Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. Published 28 October 2024. doi:10.1056/nejmoa2405880
Summarised from the published abstract; every number is checked against it