Earlier TAVR Cut Heart-Failure Events in Selected Patients With Moderate Aortic Stenosis

Replacing a narrowed heart valve before the disease becomes severe reduced heart-failure events in selected older adults with moderate aortic stenosis, according to the randomized PROGRESS trial. The benefit was meaningful, but it was driven by fewer heart-failure episodes rather than lower mortality, and the result does not support treating every person with moderate disease.

Key Number: Early TAVR lowered the primary outcome by 7.2 percentage points at two years, from 23.9% with surveillance to 16.7%.

Testing treatment before stenosis becomes severe

Aortic stenosis narrows the valve that controls blood flow from the heart into the aorta. Valve replacement is established for severe disease, while moderate stenosis is usually followed with periodic echocardiography until it progresses or another indication for intervention appears.

PROGRESS tested whether that waiting strategy is best for a higher-risk subset. The international trial enrolled people aged 65 or older who had moderate calcific stenosis plus at least one feature associated with worse outcomes, such as symptoms, impaired heart function or structural damage. Their average age was about 78, and 96% had at least moderate symptoms.

Investigators at 74 centers in six countries randomly assigned 373 participants to transfemoral transcatheter aortic-valve replacement, or TAVR, using the SAPIEN 3 platform and 371 to clinical surveillance. The study was open-label because patients and clinicians could not be blinded to a valve procedure.

Fewer heart-failure events, not fewer deaths

At two years, the combined primary outcome of death from any cause or a heart-failure event occurred in 16.7% of the early-TAVR group and 23.9% of the surveillance group. The hazard ratio was 0.67, while the absolute risk difference was 7.2 percentage points.

The components matter. Death occurred in 8.4% of patients assigned to TAVR and 7.3% assigned to surveillance, a difference that was not statistically significant. Heart-failure events were less frequent with TAVR, at 10.8% versus 19.0%. Heart-failure hospitalizations were 7.4% versus 14.9%, accounting for much of the overall benefit.

Quality of life also favored early intervention. At two years, 39% of the TAVR group were alive with at least a 10-point improvement on the Kansas City Cardiomyopathy Questionnaire, compared with 23.2% under surveillance. The trial's 30-day safety composite occurred in 5.9% of treated patients, below its prespecified performance goal.

Surveillance often led to later replacement

The comparison was between treatment strategies, not permanent valve replacement versus no replacement. Within two years, 204 of 371 people assigned to surveillance, or 57%, underwent delayed valve replacement. About four in five had progressed to severe aortic stenosis by then.

That high crossover reflects the selected population and suggests that their disease often progressed quickly. It also makes the result relevant to timing: the trial asks whether replacing the valve earlier can prevent deterioration and heart-failure episodes while patients wait for a conventional indication.

What changes now?

The immediate implication is closer evaluation of moderate stenosis with high-risk features, not automatic intervention. Clinicians will need to identify who resembles the trial population, balance procedural risk against the likelihood of rapid progression and consider regulatory and guideline updates. Participants will be followed for up to 10 years, which should clarify valve durability and whether avoiding early heart-failure events produces a longer-term benefit.