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The randomized PROGRESS trial found that patients with moderate aortic stenosis and at least one risk feature had fewer combined death or heart failure events over two years with upfront TAVR than with clinical surveillance. The result was driven by fewer heart failure events; the trial did not show a significant difference in death alone, and longer follow-up is planned.
The randomized PROGRESS trial found that upfront transcatheter aortic valve replacement (TAVR) reduced the two-year rate of death from any cause or a heart failure event compared with clinical surveillance among patients with moderate aortic stenosis (AS) and at least one at-risk feature. The results, presented at the Transcatheter Cardiovascular Therapeutics conference and published in the New England Journal of Medicine, could affect when clinicians consider valve replacement for this selected group.
At two years, the composite outcome occurred in 16.7% of patients assigned to TAVR and 23.9% assigned to surveillance. The hazard ratio was 0.67 (95% CI 0.48-0.93; P=0.02 for superiority), investigators reported. The trial’s number needed to treat for benefit over two years was 14.
The difference was driven mainly by fewer heart failure events: these occurred in 10.8% of the TAVR group and 19.0% of the surveillance group (HR 0.55, 95% CI 0.37-0.81). Death alone was not lower in the TAVR group: rates were 8.4% versus 7.3% (HR 1.14, 95% CI 0.67-1.93). Heart failure hospitalizations, reported as a separate outcome, occurred in 7.4% versus 14.9% (HR 0.48, 95% CI 0.30-0.77).
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). At 30 days, the safety event rate for TAVR using the balloon-expandable Sapien 3 platform was 5.9%, below the trial’s prespecified 13.7% performance goal. Most of those events were hospitalizations related to the device or procedure.
Quality-of-life results also favored TAVR on a measure used for patients with heart failure. At one and two years, 39.0% of patients assigned to TAVR were alive with an improvement of at least 10 points on the Kansas City Cardiomyopathy Questionnaire, compared with 23.2% in the surveillance group (P<0.001). This measure reflects reported health status; it is distinct from the trial’s clinical event outcomes.
Earlier Valve Treatment Could Change Care
The findings raise the possibility that waiting for moderate AS to become severe may not be the best approach for every patient. In the surveillance arm, 57.4% underwent delayed valve replacement by 24 months, and more than 80% of those patients had progressed to severe AS. The trial therefore compares upfront treatment with close monitoring and later intervention when warranted, rather than TAVR with no treatment.
The potential reach is substantial, but the evidence applies to the people studied, not automatically to everyone with moderate AS. Trial participants were at least 65 and had at least one risk feature. The outcomes also differed by measure: heart failure events fell, while the study did not establish a benefit for death alone or for the separate death, stroke and heart failure hospitalization composite. Clinicians and patients will need to weigh the reported benefits against procedural risks and individual circumstances.
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Who Took Part in PROGRESS
PROGRESS is described in the report as the first randomized study comparing TAVR with clinical surveillance in moderate AS. Investigators screened 1,294 people and randomized 744 patients from October 2021 to January 2024 to transfemoral TAVR or yearly surveillance. Participants had a mean age of 78; 39% were women, and 87.1% were recruited in the United States, with the remainder enrolled at sites in five other countries.
Participants had moderate AS and at least one qualifying risk feature. Valve-related symptoms were present in 96.4%, and diastolic dysfunction in 43.8%. The average valve area was 1.2 cm², mean gradient just over 25 mm Hg and peak velocity 3.3 m/s. About 35% had New York Heart Association class III or IV symptoms at baseline. The trial’s heart failure event definition required worsening symptoms, at least two objective signs of worsening and escalation of heart failure treatment.
In the conference presentation, lead investigator Philippe Généreux of Morristown Medical Center said the findings support earlier specialist evaluation. He argued that moderate AS can progress and that patients need continued monitoring. Panelist Pinak Shah of Mass General Brigham called the study a “truly practice-changing study,” while stressing the importance of close follow-up.
“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, lead investigator
Long-Term Benefit Is Still Unknown
The results cover two years, while follow-up is planned for 10 years. It remains unclear whether the early difference in the composite outcome will persist, how longer-term outcomes will compare, and how the balance of benefit and risk will develop as patients age or receive later valve procedures. The study’s reported findings also do not establish a reduction in death alone.
The evidence is limited to older patients with moderate AS plus at least one at-risk feature, treated with the tested transfemoral TAVR approach and monitored in the trial. The source report does not provide every safety outcome, including the full incidence of new permanent pacemaker placement. It also does not establish that the results apply to patients without the qualifying features or answer how treatment should be selected for an individual.
Ten-Year Follow-Up Will Add Evidence
PROGRESS participants are scheduled for follow-up through 10 years, which should provide more information about durability, later valve replacement and longer-term clinical outcomes. Until those data are available, the two-year results offer evidence for discussion and evaluation in the trial’s selected population, rather than a settled treatment rule for all moderate AS.
Généreux called for referral to a valve clinic for comprehensive assessment. For readers seeking to understand what the study means for a particular patient, the next step is a discussion with a qualified clinician familiar with that patient’s symptoms, test results and treatment options.
Key Questions
What did the PROGRESS trial find?
Among patients with moderate AS and at least one 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 composite result was driven mainly by fewer heart failure events.
Did TAVR reduce deaths in the trial?
The trial did not show a lower rate of death alone. Death occurred in 8.4% of the TAVR group and 7.3% of the surveillance group; the reported confidence interval for the comparison included no difference.
Who was included in PROGRESS?
Participants were at least 65 years old, had moderate aortic stenosis and had at least one at-risk feature. The findings do not directly establish the effect of upfront TAVR for every person with moderate AS.
Does the study mean everyone with moderate AS should have TAVR?
No. The results concern a selected trial population and do not create a universal treatment recommendation. The report calls for comprehensive evaluation and continued follow-up; individual decisions require discussion with a qualified clinician.
What evidence is still to come?
The trial has 10-year follow-up planned. Those data may clarify whether the two-year outcome difference persists and provide more information about longer-term results and valve treatment over time.
Source: medpagetoday.com
