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The randomized PROGRESS trial found that patients with moderate aortic stenosis and at least one at-risk feature had fewer deaths or heart failure events over two years with upfront TAVR than with annual clinical surveillance. The result supports considering earlier intervention for this selected group, but the trial’s follow-up is planned for 10 years and several outcomes, including death alone, did not show a significant advantage.
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 selected patients with moderate aortic stenosis (AS). The findings could support earlier valve intervention for people with moderate AS and at least one risk feature, rather than waiting for the condition to become severe.
At two years, the composite outcome occurred in 16.7% of patients assigned to TAVR and 23.9% assigned to surveillance, a relative reduction reflected by a hazard ratio of 0.67 (95% confidence interval 0.48-0.93; P=0.02 for superiority). The trial’s reported number needed to treat for benefit was 14 over two years. The composite combined death from any cause with heart failure events; those events had to meet specified symptom, objective-evidence and treatment-escalation criteria.
The difference was driven mainly by fewer heart failure events, which occurred in 10.8% with TAVR and 19.0% with surveillance. Heart failure hospitalization, reported separately, was also less frequent with TAVR: 7.4% versus 14.9%. Death alone was not lower in the TAVR group: it occurred in 8.4% versus 7.3%, with a hazard ratio of 1.14 and a confidence interval that included no difference. A separate 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).
The study enrolled 744 people aged 65 or older, randomized between October 2021 and January 2024. Participants had moderate AS and at least one at-risk feature; valve-related symptoms and diastolic dysfunction were common. The group’s mean age was 78, and about 39% were women. In the surveillance arm, 57.4% had undergone delayed aortic valve replacement by 24 months; more than 80% of those patients had progressed to severe AS, according to the report.
Earlier Treatment for Selected Patients
The findings address a practical timing question: whether some patients with moderate AS and additional risk features should be considered for valve replacement before the disease reaches the severe category. The lower rate of the trial’s combined outcome, alongside fewer heart failure events and hospitalizations, suggests that waiting for progression may not be the best course for every patient in this defined group.
The result does not establish that all people with moderate AS should receive TAVR. The study tested a particular strategy in patients aged 65 or older who had qualifying risk features, and the main benefit was driven by heart failure outcomes rather than a demonstrated reduction in death. Decisions about intervention still require assessment of symptoms, valve disease, procedural risk and other health conditions by a clinical team.
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How PROGRESS Tested Early TAVR
PROGRESS was reported as the first randomized study to compare TAVR with clinical surveillance in moderate AS. Participants were assigned either to transfemoral TAVR using the balloon-expandable Sapien 3 platform or to clinical surveillance scheduled once a year. Most participants were recruited in the United States, with other sites in Japan, Australia, the Netherlands, Canada and Switzerland.
The trial’s patients had a mean aortic valve area of 1.2 square centimeters, mean gradient just over 25 mm Hg and peak velocity of 3.3 meters per second. Nearly all had valve-related symptoms as a qualifying feature. In the TAVR group, the 30-day safety-event rate was 5.9%, below the prespecified performance goal of 13.7%; the report said most events were hospitalizations related to the device or procedure. The trial also reported better health-status scores with TAVR, including a higher share of patients alive with a 10-point or greater improvement in the Kansas City Cardiomyopathy Questionnaire score at one and two years.
“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, speaking at the TCT conference
Long-Term Benefit Still Unclear
The reported comparison covers two years, while follow-up is planned to continue for 10 years. It remains unclear whether the early difference in the composite outcome will persist, widen or change over longer follow-up, and what the long-term balance of benefit and procedural risk will be. The results also do not show a significant benefit for every measured composite: death alone was not reduced, and the composite of death, stroke or heart failure hospitalization did not reach statistical significance.
The source report does not provide all details on longer-term device outcomes or the full incidence of complications such as new permanent pacemaker implantation. Nor does this trial answer whether the findings apply to people without the qualifying risk features, to younger patients, or to all clinical and procedural settings. The results support a discussion of earlier treatment, not a universal recommendation.
Ten-Year Follow-Up Will Matter
PROGRESS participants are expected to remain under observation for up to 10 years, allowing investigators to track later clinical outcomes and the durability of the early findings. Clinicians will also need to consider the results alongside each patient’s symptoms, imaging, progression and procedural risks. For patients with moderate AS and risk features, the immediate implication is closer evaluation and follow-up rather than assuming that intervention should wait automatically until severe disease develops.
Key Questions
What did the PROGRESS trial find?
Among selected patients with moderate aortic stenosis and at least one at-risk feature, 16.7% assigned to upfront TAVR had death from any cause or a heart failure event by two years, compared with 23.9% assigned to annual clinical surveillance.
Does the trial show that everyone with moderate aortic stenosis should have TAVR?
No. The trial studied people aged 65 or older who had moderate AS plus at least one qualifying risk feature. Its findings do not establish a recommendation for every person with moderate AS; treatment decisions require an individual clinical assessment.
Was death by itself reduced with upfront TAVR?
No significant reduction in death alone was reported. Death occurred in 8.4% of the TAVR group and 7.3% of the surveillance group, and the reported confidence interval did not establish a clear difference.
What happened to patients assigned to surveillance?
By 24 months, 57.4% had undergone delayed aortic valve replacement. According to the trial report, more than 80% of those receiving delayed replacement had progressed to severe aortic stenosis.
What remains to be learned?
The trial’s reported outcomes cover two years. Follow-up is planned for 10 years, and longer observation is needed to clarify how durable the benefits are and how risks and outcomes develop over time.
Source: medpagetoday.com
