WASHINGTON (dpa-AFX) - Edwards Lifesciences (EW) reported Phase 3 PROGRESS trial results showing that transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance in patients with moderate aortic stenosis who had features associated with a higher risk of disease progression.
Aortic stenosis (AS) is a condition in which the heart's aortic valve narrows, restricting blood flow from the heart to the rest of the body. Patients with moderate disease have traditionally been monitored through regular checkups and imaging tests rather than receiving early intervention.
In the PROGRESS trial, TAVR reduced the risk of the combined endpoint of death or heart failure events by 33% over two years compared with clinical surveillance. Event rates were 16.7% in the TAVR group versus 23.9% in the surveillance group.
The benefit was largely driven by fewer heart failure complications. Heart failure events occurred in 10.8% of patients treated with TAVR compared with 19.0% of those managed with clinical surveillance. Heart failure hospitalizations were reduced by more than half, occurring in 7.4% of TAVR patients versus 14.9% of patients in the surveillance group.
TAVR also demonstrated a favorable safety profile, with no deaths and no disabling strokes reported within 30 days of the procedure.
Patients receiving TAVR reported clinically meaningful improvements in quality of life, with a 15.5-point improvement in Kansas City Cardiomyopathy Questionnaire scores at 30 days.
The study also highlighted the progressive nature of moderate aortic stenosis. Among patients initially managed with clinical surveillance, 27% underwent delayed valve replacement within one year, increasing to 57% within two years as their condition worsened.
The PROGRESS trial enrolled 744 patients across 74 sites in six countries and compared Edwards' SAPIEN 3 transcatheter valve platform against guideline-recommended clinical surveillance.
The late-breaking findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 meeting and were simultaneously published in the New England Journal of Medicine, adding to growing evidence supporting earlier intervention in selected patients with aortic stenosis.
The company has plans to announce its Q3 2026 results on November 4, 2026, after market close.
EW has traded between $74.66 and $96.29 over the past year. The stock closed Monday's trading at $93.26, up 1.36%.
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