New TAVR Research Explores Adverse Outcomes, Disease Progression in Patients with Asymptomatic Severe AS
“New TAVR Research Explores Adverse Outcomes, Disease Progression in Patients with Asymptomatic Severe AS”
Source: At ACC.25, the annual conference of the American College of Cardiology, researchers presented two key follow-up studies focused on data from the EARLY TAVR trial.
Summary:
1. Background: The EARLY TAVR Trial
• A randomized controlled trial (RCT) comparing early transcatheter aortic valve replacement (TAVR) vs. clinical surveillance (CS) in 901 patients with asymptomatic severe aortic stenosis (AS).
• Mean age: 75.8 years, 69% male, STS risk score: 1.8% (low surgical risk).
• Primary outcome: Composite of all-cause mortality, stroke, and unplanned cardiovascular hospitalizations.
• Key finding: TAVR patients had a lower event rate (26.8%) compared to CS patients (45.3%), mainly due to fewer unplanned hospitalizations (20.9% vs. 41.7%).
2. ACC.25 Follow-Up Analysis: Delayed vs. Early TAVR
• Study Aim: Evaluate outcomes of patients initially managed with CS who later developed symptoms and underwent delayed aortic valve replacement (AVR).
• Comparison groups:
• Early TAVR (n=444) vs. Delayed AVR (n=388).
• Findings:
• Delayed AVR had worse outcomes:
• Higher composite event rate (10.6% vs. 6.8%).
• Increased stroke risk (1.8% vs. 0.9% peri-procedural; 4.5% vs. 2.7% at 2 years).
• Higher all-cause mortality and heart failure hospitalizations.
• Acute valve syndrome (NYHA III/IV, arrhythmias, LV dysfunction) was a major risk factor for adverse outcomes in delayed AVR patients.
• Conclusion: Early TAVR may prevent progression to acute valve syndrome and poor outcomes.
3. Expert Opinions & Stroke Risk Considerations
• Dr. Robert Bonow (JAMA Cardiology Editor-in-Chief):
• Emphasized inevitability of TAVR in asymptomatic severe AS.
• Warned against waiting, as delaying intervention may increase stroke risk.
• Dr. Philippe Généreux (Lead Investigator):
• Expressed surprise at high stroke rates in delayed AVR.
• Hypothesized that severe AS itself may be a stroke risk factor.
4. Biomarker Analysis for Risk Prediction
• NT-proBNP & hs-cTnT were measured to determine if they predict TAVR timing needs.
• Findings:
• Higher biomarker levels were linked to worse outcomes.
• However, they did not provide useful guidance for timing TAVR.
• Conclusion: AS progression is unpredictable, reinforcing the benefits of early TAVR regardless of biomarker levels.
5. Industry Perspective
• Edwards Lifesciences (Study Sponsor):
• Reaffirmed commitment to advancing TAVR science and expanding Sapien valve use.
• Sapien valve has treated over 1 million patients worldwide.
6. Final Takeaway
• Early TAVR appears to provide significant benefits over clinical surveillance, reducing hospitalizations, stroke, and mortality.
• Waiting for symptoms may increase risk of acute valve syndrome and poorer outcomes.
• The optimal timing for TAVR in asymptomatic AS patients remains a key research focus.
