Valvular & structural heart disease
Transcatheter Aortic Valve Replacement or Medical Treatment for Paradoxical Low-Flow, Low-Gradient Aortic Valve Stenosis: REBOOT-PARADOX
- Enrollment stopped prematurely for slow recruitment
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
- Transcatheter aortic valve replacement (TAVR) plus optimal medical therapy (OMT) vs OMT alone
- TAVRn = 80
- OMTn = 40reference
- Primary endpoint
- All-cause death
- Follow-up
- 2 years after enrollment of the last patient
Methodological detailsmulticentre, open-label, 2:1 randomisation, 19 OMT patients crossed over to TAVR, most for symptom progression
- Multicentre
- Open-label
- 2:1 randomisation
- 19 OMT patients crossed over to TAVR, most for symptom progression
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: REBOOT-PARADOX. J Am Coll Cardiol. Published 28 August 2026. doi:10.
Summarised from the published abstract; every number is checked against it