Illustrative consultation, not a PROGRESS trial participant.
Replacing a narrowed heart valve earlier reduced a combined measure of death or heart-failure events in a carefully selected group of older adults with moderate aortic stenosis. The PROGRESS trial, published on 2 November 2026, offers useful progress, but it does not mean that everyone with moderate valve narrowing should have a procedure.
The important distinction is that the combined outcome improved, while deaths alone did not show a benefit. The manufacturer also states that using its SAPIEN 3 systems for moderate aortic stenosis remains investigational.
What Is Moderate Aortic Stenosis?
The aortic valve controls blood leaving the heart for the rest of the body. Aortic stenosis means this opening has narrowed, making it harder for blood to pass through. In older adults, calcium build-up can make the valve stiff. An ultrasound scan called an echocardiogram helps the heart team assess how narrow it has become.
Moderate describes the measured severity, not how a person feels. Some people have no symptoms; others develop breathlessness, chest discomfort, dizziness or reduced ability to manage everyday activities. These symptoms can also have other causes. Confirming the valve measurements and looking for other heart conditions are therefore essential.
Who Took Part in PROGRESS?
Researchers randomly assigned 744 adults at 74 centres in six countries to earlier transcatheter aortic valve replacement, known as TAVR, or clinical surveillance with valve replacement later when indicated. TAVR delivers a replacement valve through a catheter. The study used a balloon-expandable valve from the SAPIEN 3 family, through an artery in the groin.
Participants were at least 65 years old, with an average age of about 78. Around 39% were women. All had moderate aortic stenosis plus at least one additional feature linked to greater risk, such as symptoms or evidence of heart damage or dysfunction. About 96% had valve-related symptoms, and many had several risk features.
Diabetes was common in this population, as the accompanying editorial notes. However, this was not a trial of a diabetes treatment, and its overall result should not be presented as proof of a particular benefit for people with diabetes. It also does not establish the best approach for younger, symptom-free people with uncomplicated moderate narrowing.
What Did the Trial Find?
The main effectiveness outcome combined death from any cause with a heart-failure event, whether or not it required hospital admission. At two years, the estimated rates were:
- 16.7% with earlier TAVR.
- 23.9% with clinical surveillance.
That is an absolute difference of 7.2 percentage points, or roughly seven fewer people per 100 experiencing the combined outcome over two years in this study. The 95% confidence interval for the difference ranged from 1.3 to 13.1 percentage points fewer events. This range reflects uncertainty about the size of the benefit.
Heart-failure events accounted for the favourable difference. Deaths alone were estimated at 8.4% with TAVR and 7.3% with surveillance. The trial therefore does not demonstrate that earlier TAVR helped people live longer.
Surveillance was not the same as receiving no care. People continued to be monitored and could have valve replacement when needed. By two years, about 57% of the surveillance group had undergone a later valve procedure, most often after progression to severe aortic stenosis.
What About Procedure Risks?
Earlier treatment also means bringing forward the risks of an invasive procedure. In the TAVR group, 21 of 358 people who underwent the initial procedure, or 5.9%, experienced the trial’s combined 30-day safety outcome. This included death, stroke, life-threatening or fatal bleeding, severe acute kidney injury, certain device- or procedure-related hospital admissions, or valve dysfunction requiring another intervention.
The safety result was assessed against a prespecified performance target. It was not proof that TAVR was risk-free or safer than having no procedure. The paper also reported new permanent pacemaker implantation in 13% of TAVR patients. Longer-term questions include replacement-valve durability and the possibility of further treatment.
Why the Results Need Careful Interpretation
The trial was open-label: patients and clinicians knew which treatment had been assigned. The committee assessing clinical events also knew the assignments, creating a possibility of reporting or assessment bias. Edwards Lifesciences, the valve manufacturer, funded the study.
The selected participants had more symptoms and risk features than many people with moderate aortic stenosis. Follow-up for the main result was two years. The balance between an earlier procedure, future valve durability and long-term benefit needs further study. Better treatment of coexisting conditions could also affect the comparison.
The independent editorial accompanying the paper stresses that TAVR is not appropriate for most adults with moderate aortic stenosis. It highlights careful confirmation of severity, treatment of other conditions and shared decisions for selected older patients. A new trial is evidence to consider, not automatically a new guideline or regulatory indication.
What Can Patients Ask Their Heart Team?
- Are my valve measurements definitely moderate, and when should they be checked again?
- Could my symptoms be coming from the valve, another heart condition or something else?
- Do I have the additional risk features studied in PROGRESS?
- Would review by a specialist valve team help, and what are the benefits and risks of my available options?
Keep agreed follow-up appointments and tell your healthcare team about new or worsening symptoms rather than waiting for the next routine scan. Do not change medicines or decide to postpone or request a procedure solely because of this report. For severe or sudden symptoms, seek urgent medical help.
For wider background, see our guides to heart and kidney protection with SGLT2 medicines and exercise as part of heart care. Neither replaces advice tailored to a known valve condition.
Sources
- PROGRESS randomised trial, New England Journal of Medicine, 2 November 2026.
- Accompanying editorial on applying the findings to selected older adults.
- American College of Cardiology trial report.
- PROGRESS trial registry, NCT04889872.
- Manufacturer announcement and investigational-use statement.
- American Heart Association: aortic stenosis overview and what TAVR involves.