Valvular & structural heart diseaseRandomised controlled trial
Transcatheter Aortic Valve Replacement or Medical Treatment for Paradoxical Low-Flow, Low-Gradient Aortic Valve Stenosis
- Randomised controlled trial
- multicentre
- open-label
- 2:1 randomisation
- Enrollment stopped prematurely for slow recruitment
19 optimal medical therapy (OMT) patients crossed over to transcatheter aortic valve replacement (TAVR), most for symptom progression
Authors' conclusion
Although the effect of TAVR on mortality remains unresolved, these findings support an individualized strategy with close surveillance and timely TAVR upon clinical deterioration in selected patients with pLFLG AS.
Study context
- Population
- Symptomatic patients with paradoxical low-flow, low-gradient aortic stenosis (AS) (aortic valve area ≤1.0 cm², mean gradient <40 mm Hg, stroke volume index <35 mL/m², EF ≥50%)783 planned
- Participants
- 120 patients
- Comparison
- TAVR plus OMT vs OMT alone
- TAVRn = 80
- OMTn = 40reference
- Primary endpoint
- All-cause death
- Follow-up
- 2 years after enrollment of the last patient
Primary result
As reported in the abstract
All-cause death, TAVR vs OMT
29.0% vs 37.1% (HR 0.83; 95% CI 0.41-1.66; P = 0.60)
Further findings
5-year mortality
- 5-year mortality, TAVR vs OMT
- 44.9% vs 56.6% (HR 0.76; 95% CI 0.43-1.35; P = 0.35)
NYHA functional class I/II · 1 year
- NYHA class I/II at 1 year, TAVR vs OMT
- 83.0% vs 59.0%
First endpoint-related rehospitalizations
- Lower cumulative incidence with TAVR
Functional capacity, quality of life
- No differences
Original publication
Transcatheter Aortic Valve Replacement or Medical Treatment for Paradoxical Low-Flow, Low-Gradient Aortic Valve Stenosis. J Am Coll Cardiol. Published 28 August 2026. doi:10.1016/j.jacc.2026.08.017
Summarised from the published abstract; every number is checked against it