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Edwards Lifesciences has announced results from the PROGRESS Trial, a randomized study in patients with moderate aortic stenosis (AS) and at-risk features. TAVR was superior to clinical surveillance on the primary endpoint of death or heart failure event at two years: 16.7% versus 23.9%, a 33% relative reduction. The results were presented as a late-breaker at TCT 2026 and published in The New England Journal of Medicine.
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The reduction came from heart failure. Heart failure events occurred in 10.8% of TAVR patients versus 19% under surveillance, and heart failure hospitalizations in 7.4% versus 14.9%. All-cause mortality at two years was similar in both groups. At 30 days, TAVR patients had no mortality and no disabling strokes, and their Kansas City Cardiomyopathy Questionnaire score improved by 15.5 points. Results favored TAVR across prespecified subgroups.
Surveillance patients also progressed faster than expected: 27% underwent delayed aortic valve replacement within one year and 57% within two years.
Moderate AS has traditionally been managed with an echocardiogram every one to two years. Dr. Philippe Généreux of Atlantic Health Morristown Medical Center said the findings challenge the assumption that these patients can be managed passively, and together with the EARLY TAVR trial support a more proactive approach. Dan Lippis, Edwards’ corporate vice president of TAVR, called the results a shift in how clinicians think about moderate AS.
