EARLY TAVR
Trial question
What is the role of early TAVR strategy in patients with asymptomatic severe aortic stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 901
901 patients (278 female, 623 male).
Inclusion criteria: patients with asymptomatic severe aortic stenosis.
Key exclusion criteria: Society of Thoracic Surgeons Predicted Risk of Mortality score > 10%; LVEF < 50%; any other class I indication for aortic valve replacement.
Interventions
N=455 early TAVR (transfemoral TAVR).
N=446 clinical surveillance (standard care in accordance with ACC and AHA guidelines).
Primary outcome
Death from any cause, stroke, or unplanned hospitalization for cardiovascular causes
26.8%
45.3%
45.3 %
34.0 %
22.6 %
11.3 %
0.0 %
Early
TAVR
Clinical
surveillance
Significant
decrease ▼
NNT = 5
Significant decrease in death from any cause, stroke, or unplanned hospitalization for cardiovascular causes (26.8% vs. 45.3%; HR 0.5, 95% CI 0.4 to 0.63).
Secondary outcomes
Significant increase in favorable outcome at 2 years (86.6% vs. 68%; AD 18.5%, 95% CI 12.6 to 24.3).
Significant increase in integrated measures of LV and LA health at 2 years (48.1% vs. 35.9%; AD 12.2%, 95% CI 4.4 to 19.4).
No significant difference in new-onset AF (13% vs. 12.4%; HR 1.08, 95% CI 0.73 to 1.6).
Safety outcomes
No significant difference in procedure-related adverse events in patients who underwent aortic valve replacement.
Conclusion
In patients with asymptomatic severe aortic stenosis, early TAVR was superior to clinical surveillance with respect to death from any cause, stroke, or unplanned hospitalization for cardiovascular causes.
Reference
Philippe Généreux, Allan Schwartz, J Bradley Oldemeyer et al. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2024 Oct 28. Online ahead of print.
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