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November 2, 2026New England Journal of Medicine
TAVR in Patients with Moderate Aortic Stenosis with At-Risk Features
Philippe GénéreuxRaj MakkarPhilippe PibarotJeroen J. BaxBrian R. LindmanKamran I. MuhammadJ. Bradley OldemeyerMark J. PirwitzColin M. BarkerVinod H. ThouraniPradeep YadavRoberto RodríguezJustin A StroteRahul SakhujaRamzi KhalilRahul SharmaAdnan K. ChhatriwallaJacob M. MishellBiswajit KarSameer GafoorJoseph WalshDaniel B. SpoonAndrew D. FrutkinAndrei PopNicolas M. Van MieghemRuby SatpathyKenji AndòJoseph MontarelloJohn WebbSreekanth VemulapalliDavid J. CohenAakriti GuptaBrandon ParkHeather PrincePhilipp BlankeMichael MackMartin B. Leon
Key result
TAVR beats surveillance in reducing 2-year death or heart-failure events in at-risk moderate AS.
- n=744
Why the study?
Current guidelines recommend clinical and echocardiographic surveillance every 1 or 2 years for patients with moderate aortic stenosis, and whether TAVR improves outcomes in these patients with at-risk features was unknown.
Does transfemoral TAVR with a balloon-expandable valve reduce the composite of all-cause death or heart-failure events compared to clinical surveillance in patients with moderate aortic stenosis and at-risk features?
Key Points
- To determine whether transcatheter aortic-valve replacement improves 2-year clinical outcomes compared with clinical surveillance in patients with moderate aortic stenosis and at-risk features.
- International, open-label, randomized trial (PROGRESS, NCT04889872) assigning 744 patients in a 1:1 ratio to transfemoral TAVR with a balloon-expandable valve (N=373) or clinical surveillance (N=371).
- Enrolled patients had moderate aortic stenosis and at least one symptom or structural/functional abnormality linked to rapid disease progression or adverse cardiovascular outcomes.
- The primary effectiveness endpoint was a composite of all-cause mortality or a heart-failure event with or without hospitalization at 2 years, evaluated by superiority testing in the intention-to-treat population.
- Participants had a mean age of 78 years, 39.1% were women, 45.6% were at low surgical risk, and the mean baseline aortic-valve area was 1.2 cm².
- TAVR was superior to clinical surveillance in significantly lowering the composite incidence of all-cause mortality or heart-failure events at 2 years.
Study Design
Type
RCT (n=744)
Blinding
Open-label
Randomization
1:1 ratio
Multicenter
Yes
Structured PICO
Does transfemoral TAVR with a balloon-expandable valve reduce the composite of all-cause death or heart-failure events compared to clinical surveillance in patients with moderate aortic stenosis and at-risk features?
P
Population
744 patients (mean age 78 years, 39.1% women, 45.6% low surgical risk) with moderate aortic stenosis and at least one at-risk feature, followed for 2 years.
I
Intervention
Transfemoral transcatheter aortic-valve replacement (TAVR) with a balloon-expandable valve (n=373)
C
Comparator
Clinical surveillance (n=371)
O
Outcome
Composite of death from any cause or a heart-failure event with or without hospitalization at 2 yearscomposite
In patients with moderate aortic stenosis and at-risk features, early transfemoral TAVR is superior to clinical surveillance in reducing all-cause death or heart-failure events at 2 years.
Limitations
- open-label design
Ask about this paper
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Moderate aortic stenosis is not benign. These patients will benefit from further referral to a valve center for a comprehensive evaluation to establish the optimal management strategy. Rather than waiting for progression to severe aortic stenosis, PROGRESS supports TAVI for patients with moderate aortic stenosis and at-risk features.”
“Patients with moderate aortic stenosis can already have symptoms and signs that their heart is under strain. These results show that for selected patients with at-risk features, treating the valve earlier can reduce the risk of heart-failure events before the narrowing becomes severe.”
“I think we have been very complacent waiting for [AS] to be severe. We don’t want to go too early, obviously, but I think there is a sweet spot and I think the PROGRESS trial identified the optimal timing of intervention based on safety and efficacy. We will need 10 years to determine that, but that’s the main contribution of PROGRESS.”
Implication
Early TAVR reduces death or HF events versus surveillance in moderate AS with risk features; extends intervention evidence beyond severe stenosis.
Abstract
BACKGROUND: For patients with moderate aortic stenosis, current guidelines recommend clinical surveillance with echocardiographic assessment every 1 or 2 years. Whether transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients remains unknown. METHODS: We conducted an international, open-label, randomized trial to evaluate whether TAVR will result in better outcomes than clinical surveillance among patients with moderate aortic stenosis with at least one at-risk feature (i.e., a symptom or structural or functional abnormality that has been shown to be associated with faster disease progression or adverse cardiovascular outcomes). The patients were assigned in a 1:1 ratio to undergo transfemoral TAVR with a balloon-expandable valve or clinical surveillance. The primary effectiveness end point was a composite of death from any cause or a heart-failure event with or without hospitalization at 2 years. Superiority testing was performed in the intention-to-treat population. RESULTS: A total of 744 patients underwent randomization: 373 patients were assigned to the TAVR group and 371 to the clinical-surveillance group. The mean age of patients was 78 years, 39.1% were women, and 45.6% were at low surgical risk. The mean aortic-valve area was 1.2 cm CONCLUSIONS: Among patients with moderate aortic stenosis and at-risk features, a strategy of TAVR was superior to clinical surveillance in lowering the incidence of death or a heart-failure event at 2 years. (Funded by Edwards Lifesciences; PROGRESS ClinicalTrials.gov number, NCT04889872.).
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Cite This Study
Généreux et al. (2026) conducted an RCT in Moderate aortic stenosis with at-risk features (n=744). Transfemoral TAVR with a balloon-expandable valve vs. Clinical surveillance was evaluated on Composite of death from any cause or a heart-failure event with or without hospitalization at 2 years. Transfemoral TAVR was superior to clinical surveillance in lowering 2-year death or heart-failure events in 744 patients with moderate aortic stenosis and at-risk features.