Erik Swain , 2025-05-12 14:07:00
Key takeaways:
- The benefit of TAVR vs. clinical surveillance for patients with asymptomatic severe aortic stenosis did not vary by age.
- TAVR was tied to lower stroke risk in the youngest and oldest age groups.
For patients with asymptomatic severe aortic stenosis, transcatheter aortic valve replacement was superior to clinical surveillance among all age groups, according to new data from the EARLY TAVR trial.
As Healio previously reported, in the main results of EARLY TAVR, at a median follow-up of 3.8 years, patients who underwent TAVR with a balloon-expandable valve (Sapien 3 or Sapien 3 Ultra, Edwards Lifesciences) had 50% reduced risk for the primary endpoint of all-cause death, stroke or unplanned hospitalization for CV causes compared with the surveillance group. Based on those results, the FDA on May 1 approved Edwards’ TAVR platform for treatment of asymptomatic severe aortic stenosis.
The benefit of TAVR vs. clinical surveillance for patients with asymptomatic severe aortic stenosis did not vary by age. Image: Adobe Stock
At the Society for Cardiovascular Angiography and Interventions Scientific Sessions, Philippe Généreux, MD, co-director of the Structural Heart Program at Morristown Medical Center, Atlantic Health System, New Jersey, presented new data from EARLY TAVR in which the cohort was stratified by age (65-69 years, 70-74 years, 75-79 years and 80 years). He also presented data on age and clinical presentation at the time of conversion to TAVR in the clinical surveillance group.
“While prior studies on asymptomatic patients primarily included younger patients, the EARLY TAVR trial enrolled a broader range of patients in terms of age,” Généreux said during a press conference. “Whether the relative benefit of early TAVR vs. a clinical surveillance strategy varies across age groups is unknown.”
Analysis by age
Event rates were highest in the oldest group, as expected, Généreux said during the press conference.
At 60 months, in the cohort of 901 patients, the primary endpoint favored TAVR in all four age groups (65-69 years: TAVR, 20.8%; surveillance, 39.8%; log-rank P = .009; 70-74 years: TAVR, 27.4%; surveillance, 43.3%; log-rank P = .008; 75-79 years: TAVR, 29.2%; surveillance, 52.7%; log-rank P < .0001; 80 years: TAVR, 52.2%; surveillance, 64.2%; log-rank P = .001), Généreux said during the press conference.
The outcome of death, stroke or HF hospitalization at 60 months favored TAVR in the youngest group (TAVR, 4.7%; surveillance, 25.6%; log-rank P = .016) and trended toward favoring TAVR in the oldest group, but did not favor either side in the two middle age groups, he said.
There were no significant interactions by age for the treatment effect of TAVR for the primary endpoint (P for interaction = .47), death, stroke, unplanned CV hospitalization or intervention with advanced signs or symptoms (P for interaction = .45) or death, stroke or HF hospitalization (P for interaction = .53), he said.
At 60 months, there was no difference between the treatment groups in death in any age group, but the rate of stroke was lower in the TAVR group in the youngest group (0% vs. 13%; log-rank P = .008) and the oldest group (4.2% vs. 16.5%; log-rank P = .029), Généreux said, noting that HF hospitalization significantly favored TAVR in the group aged 70 to 74 years (log-rank P = .005) and in the oldest group (log-rank P = .029).
In the clinical surveillance arm, the median time to conversion to TAVR was 11.1 months, and there were no differences by age group (log-rank P = .731), according to the researchers.
The proportion of patients who converted to TAVR with severe symptoms was consistent across age groups “but was more prevalent in older patients,” Généreux said.
Preferred strategy
“Early TAVR demonstrated benefit over clinical surveillance across all age groups,” Généreux said during the press conference. “The stroke-related benefit of early TAVR appeared to be most pronounced in younger and older patients. The absolute heart failure hospitalization benefit appeared to be most advantageous in patients aged [ 80 years]. Given the consistent benefit and the lack of harm across all age groups, a strategy of early TAVR may be preferred to clinical surveillance among patients with asymptomatic severe [aortic stenosis].”
Reference:
The study was funded by Edwards Lifesciences. Généreux reports receiving consultant fees from 4C Medical, Abbott Vascular, Abiomed, Edwards Lifesciences, Haemonetics, Pi-Cardia, Puzzle Medical, Saranas, Shockwave Medical and Teleflex, serving as principal investigator for trials sponsored by 4C Medical, Abbott Vascular and Edwards Lifesciences and holding equity in Pi-Cardia, Puzzle Medical and Saranas.
Sources/Disclosures
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Généreux P, et al. Late-breaking clinical research. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 1-3, 2025; Washington, D.C.
