Whether or not to intervene early in asymptomatic aortic stenosis was answered by EARLY TAVR in 2024, and new 5-year data presented at NYV 2026 now suggests that the benefit of early intervention is driven by reductions in death and stroke rather than just heart failure.
- EARLY TAVR reshaped the AS field when first published in 2024, leading the FDA to approve TAVR for asymptomatic patients with severe AS in 2025.
- The trial enrolled patients aged 65 or older deemed suitable for transfemoral TAVR, so the findings may not generalize to populations outside those criteria.
To assess durability of the early-intervention strategy, investigators extended follow-up to a median of 5 years, capturing outcomes for patients randomized to either early TAVR or clinical surveillance.
- The composite endpoint of death, stroke, or heart failure hospitalization was significantly lower with early TAVR (15.2% vs 24.2%).
- NEARLY-TAVR Returns, WISeR’s Funding Cuts, and IL-6 Biomarkerotably, a death-or-stroke reduction emerged specifically after the study’s 2-year mark (HR: 0.61).
The shape of the benefit also changed over time, which is the most clinically interesting part of this update.
- In the first two years, early intervention prevented roughly 70% of HF events because patients never became symptomatic (3.5% vs 10.3%).
- Beyond two years, the HF benefit faded as nearly three-quarters of surveillance patients crossed over to TAVR, while death and stroke became dominant.
- Most importantly, early intervention carried no penalty since death and stroke rates were identical between arms in the first two years.
However, the individual endpoints tell a more nuanced story when separated out.
- All-cause mortality showed no significant difference at 5 years (10.3% vs 12.3%).
- Stroke, uncoupled from death, was numerically lower with early TAVR but didn’t reach significance (4.8% vs 7.6%).
- This means the composite benefit is real but should be interpreted as directional.
The mechanism behind the death and stroke reduction also remains an open question.
- While the heart failure benefit is well understood, investigators are still working out why waiting appears to cost patients.
- Theories include: valve degeneration, new-onset AFib, and acute valve syndrome accumulating during surveillance.
The Takeaway
When you look at the composite results, EARLY TAVR’s 5-year readout still supports the FDA’s decision to approve TAVR in asymptomatic AS patients. That said, a closer look at the divided data points tells us that there’s still some questions left unanswered.
