- Question
- In patients with severe aortic stenosis and a small aortic annulus undergoing TAVR, is a self-expanding supra-annular valve noninferior for clinical outcomes and superior for bioprosthetic-valve dysfunction compared with a balloon-expandable valve?
- Design
- Randomized 1:1, open-label (no masking per the registry) trial with 716 patients treated at 83 sites in 13 countries. The coprimary end points were assessed at 12 months.
- Population
- Patients with symptomatic severe aortic stenosis and an aortic annulus area of 430 mm2 or less. Mean age was 80 years, 87% were women, and the mean STS Predicted Risk of Mortality was 3.3%.
- Intervention
- TAVR with a self-expanding supra-annular valve (Medtronic Evolut).
- Control
- TAVR with a balloon-expandable valve (Edwards SAPIEN).
- Primary outcome
- Two coprimary end points at 12 months: a composite of death, disabling stroke, or rehospitalization for heart failure (noninferiority) and a composite of bioprosthetic-valve dysfunction (superiority).
- Results
- The clinical composite occurred in 9.4% with the self-expanding valve and 10.6% with the balloon-expandable valve (difference, -1.2 percentage points; 90% CI, -4.9 to 2.5; P<0.001 for noninferiority). Bioprosthetic-valve dysfunction was 9.4% versus 41.6% (difference, -32.2 percentage points; 95% CI, -38.7 to -25.6; P<0.001 for superiority). The mean gradient at 12 months was 7.7 mm Hg versus 15.7 mm Hg.
- Safety
- Major safety end points appeared similar in the two groups.
- Conclusion
- In small annuli, the self-expanding supra-annular valve was noninferior for clinical events and superior for bioprosthetic-valve dysfunction through 12 months.
- Why it matters
- It provided randomized evidence to guide valve selection in patients with a small annulus, most of them women, in whom hemodynamic performance is a central concern. It highlighted the importance of prosthesis design in avoiding prosthesis-patient mismatch.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026