Valvular & structural heart diseaseRandomised controlled trial
Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years
- Randomised controlled trial
Authors' conclusion
Among low-risk patients with severe, symptomatic aortic stenosis who underwent TAVR or surgery, there was no significant between-group difference in the two primary composite outcomes.
Study context
- Population
- Patients with severe, symptomatic AS at low surgical risk
- Participants
- 1,000 patients
- Comparison
- Transcatheter aortic-valve replacement (TAVR) vs surgery
- TAVRn = 503
- Surgeryn = 497reference
- Primary endpoint
- First: composite of death, stroke or rehospitalization (valve, procedure or HF); second: hierarchical composite of death, disabling stroke, nondisabling stroke and rehospitalization days (win ratio)
- Follow-up
- 5 years
Primary result
As reported in the abstract
Difference
−4.3 percentage points
95% CI −9.9 to 1.3
P = 0.07
Events by treatment group
TAVR vs Surgery
difference −4.3 percentage points (95% CI −9.9 to 1.3); P = 0.07
- Win ratio, second primary end point (hierarchical composite: death, disabling stroke, nondisabling stroke, rehospitalization days)
- 1.17 (95% CI, 0.90 to 1.51; P = 0.25)
Further findings
Components of first primary end point · Kaplan-Meier estimates
Death
Stroke
Rehospitalization
Mean valve gradient
Safety
Bioprosthetic-valve failure
Original publication
Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. Published 24 October 2023. doi:10.1056/nejmoa2307447
Summarised from the published abstract; every number is checked against it