Benefits of TAVI Before Symptom Onset Not Hindered by Age: EARLY TAVR

WASHINGTON, DC—No matter whether they’re in their mid to late 60s, 70s, or older, patients who have severe aortic stenosis (AS) in the absence of symptoms benefit more from early intervention with TAVI than they do from a strategy of watchful waiting, an analysis of the EARLY TAVR trial shows.

The primary endpoint of death, stroke, or unplanned CV hospitalization was lower with TAVI regardless of age, said principal investigator Philippe Généreux, MD (Morristown Medical Center, NJ), in his presentation here at SCAI 2025.

“Severe aortic stenosis is an unpredictable disease, and we have shown with the EARLY TAVR trial that symptoms can develop quickly and the situation can become more complex when you don’t refer and treat promptly. Even in our screening process we saw that 20% of patients who were thought to be asymptomatic ended up having a class I indication for AVR on workup,” Généreux told TCTMD.

“So regardless of age,” he added, “what we need to do is to see aortic stenosis the way it deserves to be seen, which is [as] a progressive disease that could be deadly and associated with poor outcomes if untreated, and better outcomes with treatment than if you wait.”

The new analysis comes just a day after the US Food and Drug Administration approved the balloon-expandable Sapien 3 platform (Edwards Lifesciences) for treatment of asymptomatic severe AS on the basis of the positive data from EARLY TAVR.

As physicians now begin to ponder TAVI for their asymptomatic patients, Généreux said his message is simple.

“The key word here is ‘plan,’ and to some extent this is just common sense,” he said. “You want to do the procedure in an elective fashion when the patient is stable. For that to happen and everything to come together, you need to be thinking ahead. That being said, you don’t have to rush anyone into the cath lab, but start planning and having the conversation so the patient is ready and understands why this is necessary.”

Some Differences Across Decades

The subanalysis separated patients by age into four groups: 65-69 years, 70-74 years, 75-79 years, and 80-plus years. Its results hinted that younger and older patients may have more enhanced benefits with TAVI than other age groups. Compared with the other, older age groups, those aged 65-69 years saw the greatest difference in the alternative primary endpoint of death, stroke, and heart failure (HF) hospitalization between TAVI and surveillance (25.6% vs 4.7%, respectively; log-rank-P = 0.016).

Both the youngest and the oldest groups had reductions in stroke at 5 years of follow-up, a benefit not observed in others. In those aged 65-69, stroke rates after randomization were 13% in the surveillance arm and zero in the TAVI arm. In those ages 80 and older, the rate was about four times higher at 16.5% with surveillance and 4.2% with TAVI.

For the individual endpoint of HF hospitalization, all age groups had lower rates with TAVI than with surveillance, but there were trends for higher levels of benefit at 5 years in the 70-74 age group where rates were 0.8% versus 9.2%, respectively (log-rank P = 0.005), and in the 80 and over group where rates were 8.7% versus 19.4%, respectively (log-rank P = 0.008).

There were no differences by age in time to conversion to AVR in the surveillance arm, with similar rates of conversion with acute or no symptoms, or with progressive signs and symptoms.

Get the dental clearance early, get organized, do your shared decision-making with all the pros and cons that the patient needs to know, and make your plan. Philippe Généreux

Généreux said the findings are hypothesis-generating and need to be examined in larger datasets.

“My opinion is that the longer you wait, the [greater the chance that] the patient develops more cardiac damage and also the valve can become more calcified. These are reasons why patients can develop more stroke while waiting,” he added. Up to 25% of the strokes in the surveillance group of the main cohort occurred during the waiting period, while the other 75% happened following the delayed AVR procedure.

“I'd be really cautious looking at your small subgroup of 65 to 69 and your small subgroup of greater than 80 [in saying] that's where the stroke is reduced,” cautioned Gregg Stone, MD (Icahn School of Medicine at Mount Sinai, New York, NY), a panelist during the late-breaking trial session. Numbers by age group are small, events are few, and there is no dose-response relationship with TAVI by age, he said. “But I think that pretty much the results are consistent, independent of age.”

Compared with younger patients, those in the oldest age group were generally sicker with more comorbidities and had higher rates of the primary endpoint in both treatment groups out to 60 months. They also did worse for the endpoint of death, stroke, or HF hospitalization, though the advantage of TAVI over surveillance remained.

“I think what we have learned is let’s not gamble with these patients thinking you have time and can wait to treat them,” Généreux told TCTMD. “Get the dental clearance early, get organized, do your shared decision-making with all the pros and cons that the patient needs to know, and make your plan.”