Valvular & structural heart diseaseRandomised controlled trial
Self-Expanding or Balloon-Expandable Transcatheter Aortic-valve Replacement (TAVR) in Patients with a Small Aortic Annulus
- Randomised controlled trial
- non-inferiority
- 83 sites in 13 countries
Authors' conclusion
Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months.
Study context
- Population
- Patients with symptomatic severe AS and an aortic-valve annulus area of 430 mm² or less
- Participants
- 716 patients
- Comparison
- Self-expanding supraannular valve vs balloon-expandable valve for TAVR
- Primary endpoint
- Coprimary: composite of death, disabling stroke or rehospitalization for HF (noninferiority); composite of bioprosthetic-valve dysfunction (superiority)
- Follow-up
- 12 months
Primary result
As reported in the abstract
Self-expanding valve
9.4%
Death, disabling stroke or HF rehospitalization (Kaplan-Meier) · Bioprosthetic-valve dysfunction (Kaplan-Meier) 9.4%
Balloon-expandable valve
10.6%
Death, disabling stroke or HF rehospitalization (Kaplan-Meier) · Bioprosthetic-valve dysfunction (Kaplan-Meier) 41.6%
Secondary outcomes
Aortic-valve mean gradient · 12 months
P < 0.001
Mean effective orifice area · 12 months
P < 0.001
Hemodynamic structural valve dysfunction · 12 months
P < 0.001
Bioprosthetic-valve dysfunction in women (subgroup) · 12 months
P < 0.001
Moderate or severe prosthesis-patient mismatch · 30 days
P < 0.001
Safety
Major safety end points
- Appeared to be similar in the two groups
Original publication
Summarised from the published abstract; every number is checked against it