Investigators presented data from the transcatheter aortic valve replacement (TAVR) study at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, D.C. Findings from the EARLY-TAVR trial were published simultaneously in The New England Journal of Medicine.
Edwards’ trial looks at the best strategy for treating asymptomatic severe aortic stenosis (AS). Results demonstrated that asymptomatic AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance.
With a median follow-up of 3.8 years, data demonstrated the superiority of early TAVR. Edwards reported that 26.8% of the 455 patients in the TAVR arm experienced death, stroke or unplanned cardiovascular hospitalization. That compared to nearly half (45.3%) of the 446 patients in the clinical surveillance arm.
Other findings included early TAVR preventing the unpredictable and rapid progression of symptoms and rapid decline in quality of life. Investigators also found that early TAVR resulted in a numerically lower rate of stroke for patients (4.2% vs. 6.7%).
In the 12-month follow-up to randomization, the conversion rate from the clinical surveillance arm to valve replacement came in at 47.2%.
“This is the first pivotal trial to generate evidence about the best strategy for disease management of severe aortic stenosis,” said Larry Wood, Edwards’ corporate VP and group president, TAVR and surgical structural heart. “EARLY TAVR challenges the current standard of care by definitively showing that patients who don’t have symptoms of severe aortic stenosis have a deadly disease that requires urgent treatment.”
