New analysis from the EARLY TAVR trial showed patients between the age of 65 and 70 years old derived the most benefits of a strategy of early intervention with transcatheter aortic valve replacement (TAVR) compared to other age groups, especially in regards to stroke risk, and in regards to the composite of death, stroke, and heart failure hospitalization. The late-breaking results were presented today at the Society for Cardiovascular Angiography & Interventions (SCAI) 2025 Scientific Sessions.
As many as 300,000 Americans are diagnosed with AS each year, a serious condition that occurs when the aortic valve in the heart is narrowed or blocked.Two strategies to manage asymptomatic severe AS are typically performed; clinical surveillance (CS), with routine monitoring and aortic valve replacement only when symptoms developed, or aortic valve replacement. For patients with asymptomatic, severe AS, the EARLY TAVR trial demonstrated that a strategy of early TAVR was superior to CS for the primary endpoint of death, stroke, or unplanned cardiovascular hospitalization. This data presentation will provide the first report from the randomized, controlled EARLY TAVR trial on whether a patient's age should influence decision-making on procedural timing for patients with asymptomatic, severe AS.
The primary goals of the study were to quantify death, stroke, and unexpected cardiovascular hospitalization. Researchers found 901 patients with asymptomatic severe AS and placed 455 into an early TAVR group and 446 into a CS group. The average follow-up time was 3.8 years. Baseline characteristics and health status were similar between treatment groups.
Older age was associated with higher rates of death, stroke, or HF hospitalizations up to five years post-procedure for both patient groups. Early TAVR demonstrated benefits over CS 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% CS) and had six times lower rate of death, stroke, or HF hospitalization compared to those who underwent CS (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 TAVR strategy associated with a 4-fold reduction in stroke up to 5 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 TAVR should be preferred to clinical surveillance in all age groups."
Philippe Genereux, MD, Director of the Structural Heart Program at the Gagnon Cardiovascular Institute at Morristown Medical Center, Morristown, New Jersey, Principal Investigator of the EARLY TAVR trial, and lead author of the study