Randomised controlled trial
3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
- Randomised controlled trial
Authors' conclusion
Within the Evolut Low Risk study, TAVR at 3 years showed durable benefits compared with surgery with respect to all-cause mortality or disabling stroke.
Study context
- Population
- Low-surgical risk patients with aortic stenosis (mean age 74 years, 35% women)
- Participants
- 1,414 attempted implantations
- Comparison
- Transcatheter aortic valve replacement (TAVR) vs surgery
- TAVRn = 730
- Surgeryn = 684reference
- Primary endpoint
- All-cause mortality or disabling stroke
- Follow-up
- 3 years
Primary result
As reported in the abstract
Hazard ratio
0.70
95% CI 0.49–1.00
P = 0.051
By group
TAVR vs Surgery
HR 0.70 (95% CI 0.49–1.00); P = 0.051
Secondary outcomes
Mild paravalvular regurgitation
Mean valve gradient · 3 years
P < 0.001
All-cause mortality or disabling stroke, difference between arms over time
- Year 1
- −1.8%
- Year 2
- −2.0%
- Year 3
- −2.9%
Moderate or greater paravalvular regurgitation
- <1% in both groups, not significantly different
Safety
Pacemaker placement
P < 0.001
Original publication
3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. Published 5 March 2023. doi:10.1016/j.jacc.2023.02.017
Summarised from the published abstract; every number is checked against it