Aortic Stenosis Trial Challenges Waiting for Severe Disease

EARLIER TAVR reduced death or heart failure events in selected patients with moderate aortic stenosis over two years.

The PROGRESS trial found that transcatheter aortic valve replacement (TAVR) outperformed clinical surveillance for the composite endpoint among patients with symptoms or cardiac abnormalities associated with faster progression or adverse cardiovascular outcomes. The findings support considering earlier intervention in this selected population, although mortality alone was not lower with TAVR.

Earlier Intervention in Moderate Aortic Stenosis

The international, open-label, randomized trial enrolled 744 patients across 74 centers. Participants had moderate aortic stenosis and at least one qualifying symptom or structural or functional abnormality. Their mean age was 78 years, 39.1% were women, and 45.6% were at low surgical risk.

Patients were assigned to transfemoral TAVR with a balloon-expandable valve or clinical surveillance. Mean aortic valve area was 1.2 cm², and mean peak velocity was 3.3 m/s. The primary effectiveness endpoint combined death from any cause with a heart failure event, with or without hospitalization, at two years.

Fewer Heart Failure Events With TAVR

At two years, estimated primary endpoint rates were 16.7% with TAVR and 23.9% with surveillance, an absolute difference of 7.2 percentage points favoring intervention (95% CI, 1.3–13.1; p=0.02 for superiority).

Heart failure event estimates were 10.8% versus 19.0%, whereas all-cause mortality estimates were 8.4% versus 7.3%. The composite benefit therefore reflected fewer heart failure events rather than lower observed mortality.

Heart failure hospitalization rates were 7.4% with TAVR and 14.9% with surveillance. Additionally, 39.0% versus 23.2% survived with an improvement of at least 10 points in the Kansas City Cardiomyopathy Questionnaire overall summary score.

Patient Selection Remains Central

During follow-up, 204 patients assigned to surveillance underwent delayed aortic valve replacement. Approximately 80% had progressed to severe aortic stenosis by their procedure.

Procedure-related adverse events did not differ meaningfully between the early TAVR group and surveillance patients who subsequently underwent valve replacement. This comparison does not establish equivalent procedural risk between intervention and surveillance without replacement.

For clinicians, PROGRESS supports individualized evaluation of older patients with moderate aortic stenosis and at-risk features. Its selected population and two-year results should guide interpretation rather than a blanket move toward intervention for all patients with moderate disease.

Reference
Généreux P et al. TAVR in patients with moderate aortic stenosis with at-risk features. N Engl J Med. 2026;doi:10.1056/NEJMoa2607326.