This research is Trending!
August 29, 2026Journal of the American College of Cardiology
Transcatheter Aortic Valve Replacement or Medical Treatment for Paradoxical Low-Flow, Low-Gradient Aortic Valve Stenosis
Key result
TAVR added to OMT fails to reduce all-cause mortality compared to OMT alone.
- HR 0.83
- 95% CI 0.41-1.66
- P=0.60
- n=120
Why the study?
Paradoxical low-flow, low-gradient AS carries an adverse prognosis, but TAVR had never been compared with optimal medical therapy alone in a dedicated randomized trial.
Does TAVR added to OMT reduce all-cause mortality in symptomatic patients with paradoxical low-flow, low-gradient aortic stenosis?
Population
120 symptomatic patients with paradoxical low-flow, low-gradient AS
Comparison
TAVR added to OMT vs OMT alone
Design
Multicenter open-label randomized trial
Follow-up
5 years
Authors
Discussion
Loading...
Member takes
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
RIREBOOT-PARADOX InvestigatorsREBOOT-PARADOX trial investigator team
“While early closure left the effect of TAVR on mortality unresolved, the randomized treatment allocation, extended patient-level follow-up, and frequent crossover provide an unusual opportunity to characterize the clinical course following immediate TAVR vs. an initially conservative strategy.”
Overview
In an underpowered randomized trial of patients with paradoxical low-flow, low-gradient aortic stenosis, TAVR did not significantly reduce mortality compared to medical therapy but was associated with improved symptoms.
Key Points
- To evaluate whether transcatheter aortic valve replacement (TAVR) added to optimal medical therapy (OMT) reduces all-cause mortality in symptomatic patients with paradoxical low-flow, low-gradient aortic stenosis.
- Multicenter, open-label randomized trial (REBOOT-PARADOX, NCT03863132) enrolling 120 symptomatic patients with paradoxical low-flow, low-gradient aortic stenosis (median age 82 years; 53.3% women; aortic valve area ≤1.0 cm²).
- Patients were randomized to receive TAVR plus optimal medical therapy (N=80) or optimal medical therapy alone (N=40), with 19 medical therapy patients crossing over to TAVR due to symptom progression.
- The primary endpoint occurred in 29.0% of the TAVR group versus 37.1% of the medical therapy group (HR: 0.83; 95% CI: 0.41–1.66; P = 0.60).
- Five-year all-cause mortality was 44.9% in the TAVR arm versus 56.6% in the medical therapy arm (HR: 0.76; 95% CI: 0.43–1.35; P = 0.35).
- TAVR significantly improved 1-year NYHA functional class I/II status (83.0% vs 59.0%) and lowered endpoint-related rehospitalizations, without differences in functional capacity or quality of life.
Study Design
Type
RCT (n=120)
Blinding
Open-label
Multicenter
Yes
Structured PICO
Does TAVR added to OMT reduce all-cause mortality in symptomatic patients with paradoxical low-flow, low-gradient aortic stenosis?
P
Population
120 patients (median age 82 years, 53.3% women) with symptomatic paradoxical low-flow, low-gradient aortic stenosis.
I
Intervention
Transcatheter aortic valve replacement (TAVR) added to optimal medical therapy (OMT)
C
Comparator
Optimal medical therapy (OMT) alone
O
Outcome
All-cause mortalityhard clinical
Main Result
Hazard Ratio: 0.83 (95% CI 0.41–1.66)
Absolute Event Rate: 29% vs 37.1%
p-value: p=0.60
In an underpowered randomized trial of patients with paradoxical low-flow, low-gradient aortic stenosis, TAVR did not significantly reduce mortality compared to medical therapy but was associated with improved symptoms.
Limitations
- Underpowered (only 120 of 783 planned patients were randomized)
- High crossover rate (19 OMT patients crossed over to TAVR)
- High crossover rate (19 of 40 OMT patients crossed over to TAVR)
Coverage & sources
Journal, society, and media accounts. Useful signal, not independent expert judgment.
Cite This Study
Mehilli et al. (2026) conducted an RCT in Paradoxical low-flow, low-gradient (pLFLG) aortic stenosis (n=120). Transcatheter aortic valve replacement (TAVR) vs. Optimal medical therapy (OMT) alone was evaluated on All-cause mortality (HR 0.83, 95% CI 0.41-1.66, p=0.60). TAVR added to optimal medical therapy did not significantly reduce the primary endpoint compared to medical therapy alone (29.0% vs 37.1%; HR 0.83; 95% CI 0.41-1.66; P=0.60).