Friday, May 2, 2025

EARLY TAVR Trial Confirms Benefit of Early Aortic Valve Intervention Across All Age Groups

Introduction


In a paradigm-shifting update for cardiologists managing severe aortic stenosis (AS), new data from the EARLY TAVR trial reveal that patients, regardless of age—derive significant benefit from early transcatheter aortic valve implantation (TAVI) even before symptoms emerge. These findings, presented at SCAI 2025, come on the heels of FDA approval for the Sapien 3 valve for asymptomatic severe AS, signaling a strong shift toward proactive intervention over watchful waiting.


The Case for Early TAVI: A Progressive, Unpredictable Disease

Severe AS has long been recognized as a progressive and potentially deadly disease, even when asymptomatic. The EARLY TAVR trial confirms that early intervention with TAVI reduces the composite risk of death, stroke, or unplanned cardiovascular hospitalization, compared with clinical surveillance.

“You want to do the procedure electively when the patient is stable,” said investigators, emphasizing the importance of planning ahead and initiating shared decision-making.


Source: NEJM
 

Key Findings Across Age Groups

The trial stratified patients into four age groups: 65–69, 70–74, 75–79, and 80+. The primary outcome consistently favored TAVI across all age brackets:

  • 65–69 years:
    Dramatic reduction in death, stroke, or HF hospitalization:
    TAVI 4.7% vs Surveillance 25.6% (P = 0.016)
    Stroke rates: 0% with TAVI vs 13% with surveillance

  • 80+ years:
    Stroke: 4.2% with TAVI vs 16.5% with surveillance
    HF hospitalization: 8.7% vs 19.4% (P = 0.008)

  • 70–74 years:
    HF hospitalization reduced: 0.8% with TAVI vs 9.2% (P = 0.005)

Despite differences in comorbidity burden across age groups, the benefit of early TAVI persisted. Conversion to AVR in the surveillance group occurred at similar rates regardless of age, and importantly, 25% of strokes occurred during the wait period before delayed AVR.

Practical Implications for Clinicians

  • Get dental clearance early to avoid procedural delays.

  • Start shared decision-making discussions during the asymptomatic stage.

  • Recognize early symptoms may be underestimated, as up to 20% of “asymptomatic” patients had guideline-based indications for AVR after workup.

  • Consider subclinical cardiac damage and valve calcification progression when delaying treatment.


TAVI Device
Edwards Lifesciences' FDA-approved Sapien 3 TAVI platform for asymptomatic severe AS
Image source


Key Takeaways for Busy Clinicians

  • Early TAVI outperforms surveillance in asymptomatic severe AS, regardless of age.

  • Major endpoints—death, stroke, HF hospitalization—are reduced with TAVI.

  • Benefits are particularly striking in younger (65–69) and older (80+) patients.

  • Up to 25% of strokes occurred during the watchful waiting period.

  • Clinicians should begin planning early with thorough workups and shared decision-making.


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