Edwards Lifesciences announced on October 28, 2024, groundbreaking results from its EARLY TAVR Trial, demonstrating superior outcomes for asymptomatic severe aortic stenosis (AS) patients treated with Edwards TAVR compared to guideline-recommended clinical surveillance. The trial, the first randomized, controlled study of its kind, was presented at Transcatheter Cardiovascular Therapeutics (TCT) and simultaneously published in The New England Journal of Medicine.
With a median follow-up of 3.8 years, 26.8% of TAVR patients experienced death, stroke, or unplanned cardiovascular hospitalization, significantly lower than the 45.3% in the clinical surveillance arm. Early intervention with TAVR prevented unpredictable and rapid progression of symptoms, which often led to emergent intervention or hospitalization in the surveillance group.
The data also showed that early TAVR prevented a clinically meaningful and rapid decline in quality of life, and resulted in a numerically lower rate of stroke (4.2% vs. 6.7%). These findings challenge the long-standing 'watchful waiting' approach for asymptomatic severe AS, supporting a shift in clinical practice and guidelines.
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