In patients with moderate aortic stenosis (AS) and at least one at-risk feature, earlier TAVR lowered the incidence of death or heart failure (HF) event, reduced HF hospitalizations and improved quality of life at two years compared to clinical surveillance, according to findings from the PROGRESS trial presented at TCT 2026 and simultaneously published in NEJM.
Philippe Genereux, MD, FACC, et al., randomized 744 patients (mean age 78 years, 39.1% women, 45.6% low surgical risk) at 74 centers across the U.S., Japan, Australia, Europe and Canada to undergo TAVR or clinical surveillance. Included patients had moderate AS with at least one at-risk feature, defined as “a symptom or structural or functional abnormality that has been shown to be associated with faster disease progression or adverse cardiovascular outcomes.” The study’s primary effectiveness endpoint was a composite of death or HF event at two years post procedure.
In the TAVR group, 16.7% of patients experienced the primary endpoint compared to 23.9% in the clinical surveillance group (risk difference, –7.2 percentage points [95% CI, –13.1 to –1.3]; p=0.02 for superiority).
A secondary endpoint of death, stroke or HF hospitalization at two years was seen in 17.7% of the TAVR group and 23.3% of the clinical surveillance group. HF hospitalization was observed in 26 TAVR patients and 52 clinical surveillance patients (7.4% vs. 14.9%).
Additionally, 39% of TAVR patients survived with an improvement of at least 10 points in KCCQ overall summary score compared to 23.2% of clinical surveillance patients.
Over the two-year follow up period, 204 patients from the clinical surveillance group underwent delayed aortic valve replacement – about 80% of those patients had progressed to severe AS by the time of procedure.
“The clinical significance of moderate [AS] should not be underestimated, and these patients should be referred promptly to a valve clinic for comprehensive evaluation to establish the optimal management strategy,” said Genereux. “The PROGRESS trial shows that patients with moderate [AS] and at-risk features can safely benefit from earlier TAVR and should not wait for disease progression, ultimately achieving a better quality of life and avoiding decline in their health status.”
In an accompanying editorial comment, Catherine M. Otto, MD, FACC, writes that “TAVR is not appropriate for most adults with moderate [AS]; however, the findings from this trial suggest that it may be considered in selected older patients with coexisting conditions at high risk of adverse outcomes when other treatment approaches are not effective.”
Clinical Topics:
Cardiac Surgery, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease
Keywords:
Transcatheter Cardiovascular Therapeutics, TCT26, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Aortic Valve, Heart Failure