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The randomized PROGRESS trial found that upfront TAVR was associated with fewer deaths or heart failure events over two years than yearly clinical surveillance among patients with moderate aortic stenosis and at least one at-risk feature. The result supports considering earlier valve-team assessment, but does not establish that every person with moderate disease should receive TAVR.
The randomized PROGRESS trial found that upfront transcatheter aortic valve replacement (TAVR) reduced the rate of a combined outcome of death or heart failure events over two years, compared with clinical surveillance, in people with moderate aortic stenosis and at least one at-risk feature. The findings, presented at the Transcatheter Cardiovascular Therapeutics conference and published in the New England Journal of Medicine, raise the possibility of treating some patients before their valve disease becomes severe.
At two years, the composite outcome occurred in 16.7% of the upfront TAVR group and 23.9% of the surveillance group. The reported hazard ratio was 0.67 (95% confidence interval 0.48-0.93; P=0.02 for superiority). The trial’s number needed to treat for benefit over two years was 14, according to the report.
The difference was driven by fewer heart failure events: these occurred in 10.8% of TAVR patients and 19.0% of those assigned to surveillance. Death by itself was not lower in the TAVR group: rates were 8.4% and 7.3%, respectively, with a hazard ratio of 1.14 (95% CI 0.67-1.93). Heart failure hospitalizations, a separate outcome, were 7.4% with TAVR and 14.9% with surveillance. A different composite of death, stroke or heart failure hospitalization did not show a statistically significant advantage for TAVR (17.7% versus 23.3%; P=0.07).
Researchers randomized 744 patients aged 65 or older between October 2021 and January 2024. Participants had moderate stenosis plus at least one risk feature; valve-related symptoms and diastolic dysfunction were the most common qualifying features. The average age was 78. TAVR used the transfemoral route and a balloon-expandable Sapien 3 valve, while the comparison group received once-yearly clinical surveillance. A 30-day safety event rate of 5.9% was reported in the TAVR group, below the trial’s prespecified 13.7% performance goal. Most reported events in that measure were hospitalizations for device- or procedure-related complications.
Earlier Treatment Before Severe Stenosis
The findings matter because moderate aortic stenosis is commonly monitored until it progresses or warrants intervention, while PROGRESS tested a procedure earlier in the disease course. In this selected group, the lower rate of the combined outcome was chiefly associated with fewer heart failure events, not fewer deaths considered alone. That distinction is important when interpreting the result and discussing possible benefits and risks.
The report also points to a potentially larger population for valve assessment. Among participants assigned to surveillance, 57.4% had a delayed aortic valve replacement by 24 months; more than 80% of those who received delayed replacement had progressed to severe stenosis. These trial observations do not show that all patients with moderate disease should undergo TAVR. They do support careful follow-up and evaluation of patients whose symptoms or other risk features may make their disease clinically significant.
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How PROGRESS Tested Earlier TAVR
PROGRESS was described in the report as the first randomized study comparing TAVR with clinical surveillance in moderate aortic stenosis. Of 1,294 people screened, 744 were assigned equally to the two strategies. Most participants were recruited in the United States, with additional sites in Japan, Australia, the Netherlands, Canada and Switzerland. The trial population included patients with symptoms and other risk features, so its findings should not automatically be applied to people with moderate stenosis who do not resemble those enrolled.
At baseline, the average aortic valve area was 1.2 square centimeters, the mean pressure gradient was just over 25 mm Hg and peak velocity was 3.3 meters per second. The study assessed a defined heart failure event, requiring new or worsening symptoms, at least two objective signs of worsening and escalation of heart failure treatment. This definition, along with the composite endpoint, shapes what the reported difference means.
“Moderate AS is not benign, and these patients would benefit from earlier referral to a valve clinic for comprehensive evaluation to establish the optimal management strategy.”
— Philippe Généreux, MD, trial investigator
Questions Beyond the Two-Year Results
The results do not settle whether upfront TAVR improves long-term survival, how durable the valve strategy will be, or which specific patients with moderate stenosis are most likely to benefit. The overall composite favored TAVR, but death alone did not, and the death-stroke-heart-failure hospitalization composite was not statistically significant. The findings also apply to people who met the trial’s age and risk-feature criteria, not necessarily to all patients with moderate aortic stenosis.
Follow-up is planned for 10 years. Longer observation will be needed to clarify durability, later procedures and outcomes beyond the two-year analysis. The source report does not provide detailed results for every safety outcome, including the full experience with new permanent pacemakers.
Long-Term Follow-Up and Valve Review
Investigators plan to continue following PROGRESS participants for up to 10 years. That follow-up can help show whether the early difference in heart failure events persists and how often patients need another valve procedure. For now, the report’s stated implication is closer monitoring and comprehensive valve-clinic evaluation for people with moderate stenosis and at-risk features, rather than a blanket recommendation for TAVR.
Key Questions
What did the PROGRESS trial find?
Among patients with moderate aortic stenosis and at least one at-risk feature, the two-year rate of death or a heart failure event was 16.7% with upfront TAVR and 23.9% with clinical surveillance. The difference met the trial’s reported test for superiority.
Did TAVR reduce deaths in the trial?
Death considered separately was not lower with TAVR: the reported rates were 8.4% and 7.3%, and the confidence interval for the hazard ratio included no difference. The overall composite result was chiefly associated with fewer heart failure events.
Does this mean everyone with moderate aortic stenosis should have TAVR?
No. The trial enrolled people aged 65 or older who had moderate stenosis plus at least one at-risk feature. Its results do not establish a routine procedure for every person with moderate disease; treatment decisions require individual clinical assessment.
What happens to the trial participants next?
PROGRESS has follow-up planned for 10 years. Longer-term results are expected to provide more information about durability, later interventions and outcomes after the two-year report.
Source: medpagetoday.com
