TAVR in Patients with Moderate Aortic Stenosis with At-Risk Features

BACKGROUND: For patients with moderate aortic stenosis, current guidelines recommend clinical surveillance with echocardiographic assessment every 1 or 2 years. Whether transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients remains unknown. METHODS: We conducted an international, open-label, randomized trial to evaluate whether TAVR will result in better outcomes than clinical surveillance among patients with moderate aortic stenosis with at least one at-risk feature (i.e., a symptom or structural or functional abnormality that has been shown to be associated with faster disease progression or adverse cardiovascular outcomes). The patients were assigned in a 1:1 ratio to undergo transfemoral TAVR with a balloon-expandable valve or clinical surveillance. The primary effectiveness end point was a composite of death from any cause or a heart-failure event with or without hospitalization at 2 years. Superiority testing was performed in the intention-to-treat population. RESULTS: , and the mean aortic-valve peak velocity was 3.3 m per second. At 2 years, the Kaplan-Meier estimate of the percentage of patients with a primary effectiveness end-point event was 16.7% in the TAVR group and 23.9% in the clinical-surveillance group (risk difference, -7.2 percentage points; 95% confidence interval, -13.1 to -1.3; P = 0.02 for superiority). The Kaplan-Meier estimate of the percentage of patients who died from any cause was 8.4% in the TAVR group and 7.3% in the clinical-surveillance group; the estimates for a heart-failure event were 10.8% and 19.0%, respectively. The incidence of procedure-related adverse events did not differ meaningfully between the patients in the TAVR group and those in the clinical-surveillance group who underwent aortic-valve replacement. CONCLUSIONS: Among patients with moderate aortic stenosis and at-risk features, a strategy of TAVR was superior to clinical surveillance in lowering the incidence of death or a heart-failure event at 2 years. (Funded by Edwards Lifesciences; PROGRESS ClinicalTrials.gov number, NCT04889872.).

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Publication Details

Journal
New England Journal of Medicine
Published
2026-11-02
DOI
https://doi.org/10.1056/nejmoa2607326
Citations
1
Primary Topic
Cardiac Valve Diseases and Treatments
Type
article
Field-Weighted Citation Impact
4.32

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article

TAVR in Patients with Moderate Aortic Stenosis with At-Risk Features

Nicolas M. Van Mieghem, Philippe Généreux, Vinod H. Thourani, Ruby Satpathy et al.
1 citations
New England Journal of Medicine
Cardiac Valve Diseases and Treatments
4.32
article

TAVR in Patients with Moderate Aortic Stenosis with At-Risk Features

Nicolas M. Van Mieghem, Philippe Généreux, Vinod H. Thourani, Ruby Satpathy, Jacob M. Mishell, Colin M. Barker, Andrew D. Frutkin, Daniel B. Spoon, Rahul Sharma, Adnan K. Chhatriwalla, J. Bradley Oldemeyer, Raj Makkar, Jeroen Joost Bax, Mark J. Pirwitz, Kenji Andò, Brian R. Lindman, David J. Cohen, Ramzi F. Khalil, Philipp Blanke, Brandon Park, Justin A Strote, Rahul Sakhuja, Aakriti Gupta, Sreekanth Vemulapalli, Kamran I. Muhammad, Pradeep Yadav, Roberto Rodríguez, Biswajit O. Kar, Andrei M. Pop, Martin B. Leon, Heather K. Prince, John Webb, Joseph K. Montarello, Sameer A. Gafoor, Michael Mack, Philippe Pibarot, Joseph Walsh
article en
1 citations

Abstract

BACKGROUND: For patients with moderate aortic stenosis, current guidelines recommend clinical surveillance with echocardiographic assessment every 1 or 2 years. Whether transcatheter aortic-valve replacement (TAVR) will improve outcomes in these patients remains unknown. METHODS: We conducted an international, open-label, randomized trial to evaluate whether TAVR will result in better outcomes than clinical surveillance among patients with moderate aortic stenosis with at least one at-risk feature (i.e., a symptom or structural or functional abnormality that has been shown to be associated with faster disease progression or adverse cardiovascular outcomes). The patients were assigned in a 1:1 ratio to undergo transfemoral TAVR with a balloon-expandable valve or clinical surveillance. The primary effectiveness end point was a composite of death from any cause or a heart-failure event with or without hospitalization at 2 years. Superiority testing was performed in the intention-to-treat population. RESULTS: , and the mean aortic-valve peak velocity was 3.3 m per second. At 2 years, the Kaplan-Meier estimate of the percentage of patients with a primary effectiveness end-point event was 16.7% in the TAVR group and 23.9% in the clinical-surveillance group (risk difference, -7.2 percentage points; 95% confidence interval, -13.1 to -1.3; P = 0.02 for superiority). The Kaplan-Meier estimate of the percentage of patients who died from any cause was 8.4% in the TAVR group and 7.3% in the clinical-surveillance group; the estimates for a heart-failure event were 10.8% and 19.0%, respectively. The incidence of procedure-related adverse events did not differ meaningfully between the patients in the TAVR group and those in the clinical-surveillance group who underwent aortic-valve replacement. CONCLUSIONS: Among patients with moderate aortic stenosis and at-risk features, a strategy of TAVR was superior to clinical surveillance in lowering the incidence of death or a heart-failure event at 2 years. (Funded by Edwards Lifesciences; PROGRESS ClinicalTrials.gov number, NCT04889872.).

New England Journal of Medicine
Cedars-Sinai Medical Center (US), Royal Adelaide Hospital (AU), Ascension (US), Eisenhower Medical Center (US), Harvard University (US), University of British Columbia (CA), Duke University (US), Columbia University Irving Medical Center (US), St. Patrick Hospital (US), Leiden University Medical Center (NL), St. Paul's Hospital (CA), Piedmont Atlanta Hospital (US), Lankenau Medical Center (US), Morristown Medical Center (US), Allegheny-Singer Research Institute (US), University of Colorado Health (US), Massachusetts General Hospital (US), Oklahoma Heart Institute (US), St. Francis Hospital (US), Heart Hospital Baylor Plano (US), Kaiser Permanente San Francisco Medical Center (US), Duke Medical Center (US), Baptist Medical Center Jacksonville (US), Institut universitaire de cardiologie et de pneumologie de Québec (CA), Stanford Medicine (US), Saint Luke's Hospital (US), Saint Alphonsus Health System (US), Cardiovascular Research Foundation (US), Alexian Brothers Medical Center (US), Ziekenhuis Oost-Limburg (BE), Edwards Lifesciences (United States) (US), Kokura Memorial Hospital (JP), Mass General Brigham (US), Atlantic Health System (US), Vanderbilt University Medical Center (US), Erasmus University Rotterdam (NL), The University of Texas Health Science Center at Houston (US)
Edwards Lifesciences
Good health and well-being
Openalex Percentile: Top 4%
Cardiac Valve Diseases and Treatments
4.32
DOISourceOpenAlex
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