Edwards’ PROGRESS Trial Shows TAVR as Superior to Clinical Surveillance in Moderate AS

November 2, 2026—Edwards Lifesciences announced that the randomized PROGRESS trial met its primary endpoint, demonstrating superiority of transcatheter aortic valve replacement (TAVR) over clinical surveillance in patients with moderate aortic stenosis (AS) and at-risk features, including symptoms, cardiac damage, or dysfunction.

The results were presented as late-breaking data at TCT 2026 and simultaneously published in The New England Journal of Medicine by Généreux et al.

The PROGRESS trial enrolled 744 patients with moderate AS and at-risk features at 74 sites across six countries. Patients were randomized 1:1 to undergo transfemoral TAVR with a valve from the Sapien 3 platform (Edwards Lifesciences) or receive guideline-recommended clinical surveillance with deferred aortic valve replacement when indicated. Moderate AS was confirmed by an independent echocardiography core laboratory, and > 90% of patients met all guideline-defined echocardiographic criteria for moderate AS. At baseline, > 95% of patients were symptomatic, > 90% had preserved left ventricular ejection fraction (≥ 50%), and the mean age was 78 years.

At 2 years, TAVR was associated with a 33% relative reduction in the primary composite endpoint of all-cause death or heart failure (HF) events compared with clinical surveillance (16.7% vs 23.9%), according to the company’s press release. Additional findings included the following:

• HF events occurred in 10.8% of patients undergoing TAVR versus 19% of those assigned to clinical surveillance.
• HF hospitalizations occurred in 7.4% versus 14.9%, respectively.
• All-cause mortality at 2 years was similar between groups.

The company reported that results consistently favored TAVR across prespecified subgroups. Patients undergoing TAVR experienced a 15.5-point improvement in Kansas City Cardiomyopathy Questionnaire score at 30 days. The company also reported no deaths or disabling strokes within 30 days of TAVR.

Among patients assigned to clinical surveillance, 27% underwent delayed aortic valve replacement within 1 year, increasing to 57% at 2 years. According to Edwards, these patients experienced declining health status and increased procedural complexity before undergoing intervention.

“The PROGRESS trial validates TAVR as a treatment strategy for moderate AS patients with at-risk features and challenges the longstanding assumption that these patients can be managed by passive clinical surveillance,” said Philippe Généreux, MD, Director of the Structural Heart Program at Atlantic Health Morristown Medical Center. “Taken together, the practice-changing PROGRESS and EARLY TAVR trials deepen our understanding of aortic stenosis and reinforce the patient benefits of a more proactive approach to disease management. The evidence is now clear that intervening earlier in the disease pathway avoids significant health decline and serious cardiovascular events.”