Analysis from the EARLY TAVR trial, presented at the 2025 Society for Cardiovascular Angiography & Interventions (SCAI) scientific sessions (1–3 May, Washington, DC, USA), has shown that patients between the ages of 65 and 70 years old derived the most benefits from a strategy of early intervention with transcatheter aortic valve implantation (TAVI) compared to other age groups, especially in regards to stroke risk, and in regards to the composite of death, stroke, and heart failure hospitalisation.
Initial results from EARLY TAVR were first released in late 2024. The trial, which enrolled more than 900 patients with severe asymptomatic aortic stenosis, compared early intervention with TAVI to clinical surveillance, demonstrating a reduction in a composite of death, stroke or unplanned cardiovascular hospitalisation between the two arms out to two years, driven largely by a reduction in hospitalisations in the TAVI group.
Presenting the results of the latest analysis at SCAI 2025, EARLY TAVR principal investigator Philippe Généreux (Morristown Medical Center, Morristown, USA) reported that older age was associated with higher rates of death, stroke, or heart failure hospitalisations up to five years post-procedure for both patient groups.
Early TAVR demonstrated benefits over clinical surveillance across all age groups. That said, patients aged 65-69 who underwent early TAVR derived the most benefits, with significant reduction in stroke risk (0% early TAVR vs. 13% surveillance) and had six times lower rate of death, stroke, or heart failure hospitalisation compared to those who underwent clinical surveillance (4.7% vs. 25.6%, respectively) up to five years post-procedure. Patients aged over 80 years old also derived the most benefits in regards of stroke risk, with early TAVI strategy associated with a four-fold reduction in stroke up to five years follow-up compared to clinical surveillance
“Those results are important and highlight the benefits of early intervention among younger patients with asymptomatic severe aortic stenosis, especially in regards to stroke risk, a complication which is the most feared by patients. We are discovering that aortic stenosis itself might be an important risk factor of stroke if left untreated. Taking all together, and given the benefits and the lack of risks in patients 65 years or greater, early TAVI should be preferred to clinical surveillance in all age groups,” said Généreux.
Last week, the US Food and Drug Administration (FDA) approved the Sapien 3 (Edwards Lifesciences) TAVI platform for the treatment of severe asymptomatic aortic stenosis.
