Journal Article Randomized Controlled Trial Multicenter Study Ppublish 6 citations
PubMed: 42340728 DOI: 10.1001/jamacardio.2026.2299
Seven-Year Valve Durability With Transcatheter or Surgical Aortic Valve Replacement: An Ad Hoc Analysis of the PARTNER 3 Randomized Clinical Trial.
JAMA Cardiol 11(8):747-757
Authors: Julien Ternacle, Rebecca T Hahn, Iria Silva, Alberto Alperi, Carlos Giuliani, Antonela Zanuttini, Alexis Théron, Abdellaziz Dahou, Nicole Cristell, Timothy Woods, Ezequiel Guzzetti, Pierre Yves Turgeon, Mathieu Bernier, Haïfa Mahjoub, Amélie Paquin, Sabah Skaf, Jonathan Beaudoin, Susheel K Kodali, Mark Russo, Samir R Kapadia, S Chris Malaisrie, David J Cohen, Jonathon Leipsic, Philipp Blanke, Mathew R Williams, James M McCabe, David L Brown, Vasilis Babaliaros, Scott Goldman, Wilson Y Szeto, Philippe Généreux, Ashish Pershad, Tamim M Nazif, Yiran Zhang, Marissa Gunnarsson, John G Webb, Raj R Makkar, Vinod H Thourani, Michael J Mack, Martin B Leon, Philippe Pibarot
Affiliations
- Haut-Leveque Cardiology Hospital, Bordeaux University, Pessac, France.
- Cardiovascular Research Foundation, New York, New York.
- Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, New York.
- Department of Cardiology, Hospital Universitario Central de Asturias, Oviedo, Spain.
- Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Québec, Canada.
- Department of Cardiology, Assistance Publique, Hôpitaux de Marseille, France.
- Department of Cardiology, Geisinger Medical Center and Geisinger College of Health Sciences, Wilkes-Barre, Pennsylvania.
- Department of Cardiology, Centre hospitalier affilié universitaire regional, Trois Rivières, Québec, Canada.
- Service de cardiologie, Centre Médical Farfalla, Tunis, Tunisia.
- Cedars-Sinai Medical Center, Los Angeles, California.
- Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.
- Cleveland Clinic, Cleveland, Ohio.
- Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
- St Francis Hospital, Roslyn, New York.
- St Paul's Hospital, Vancouver, British Columbia, Canada.
- New York University-Langone Medical Center, New York, New York.
- Beth Israel Deaconess Medical Center, Boston, Massachusetts.
- Baylor Scott & White Healthcare, Plano, Texas.
- Emory University School of Medicine, Atlanta, Georgia.
- Lankenau Medical Center, Wynnewood, Pennsylvania.
- Division of Cardiovascular Surgery, University of Pennsylvania, Philadelphia.
- Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey.
- Chandler Regional and Mercy Gilbert Medical Center, Chandler, Arizona.
- Edwards Lifesciences, Irvine, California.
- Department of Cardiovascular Surgery, Piedmont Heart Institute, Atlanta, Georgia.
Abstract
IMPORTANCE
As transcatheter aortic valve replacement (TAVR) is considered for younger and lower-risk populations, the durability of bioprosthetic valves is increasingly important. Limited data exist on long-term (7 years and beyond) valve durability.
OBJECTIVE
To report 7-year valve durability outcomes for low-risk patients with symptomatic severe aortic stenosis treated with TAVR vs surgery.
DESIGN, SETTING, AND PARTICIPANTS
Between March 2016 and October 2017, a total of 1000 patients were enrolled at 71 centers in the US and Canada and randomized to undergo TAVR vs surgery. The patient population for the present analysis consisted of all patients who underwent valve implantation (495 with TAVR and 453 with surgery). The last 7-year follow-up occurred in March 2025.
INTERVENTIONS
Patients were randomized to balloon-expandable TAVR with the SAPIEN 3 valve or surgery with any commercially available valve.
MAIN OUTCOMES AND MEASURES
The main outcomes of this analysis were stage 2 or 3 bioprosthetic valve dysfunction (BVD) related to structural valve deterioration (SVD), thrombosis, or endocarditis; all-cause bioprosthetic valve failure (BVF); BVF related to SVD; and aortic valve reintervention at 7 years. Analyses are presented as cumulative incidence rates with death as a competing risk.
RESULTS
The mean (SD) age of the study population was 73.5 (6.0) years, and 657 participants (69.3%) were male. Of 671 patients who were still alive and enrolled in the study at 7-year follow-up, 537 (80.0%) were available for echocardiographic analysis. Cumulative incidence rates of stage 2 or 3 SVD-related BVD (7.3% vs 7.6%; hazard ratio [HR], 0.96; 95% CI, 0.59-1.57; P = .88), all-cause BVF (6.9% vs 7.5%; HR, 0.91; 95% CI, 0.55-1.49; P = .69), SVD-related BVF (3.9% vs 5.3%; HR, 0.72; 95% CI, 0.39-1.36; P = .31), and valve reintervention (6.0% vs 5.5%; HR, 1.09; 95% CI, 0.62-1.90; P = .77) were low and similar for TAVR and surgery, respectively. Stage 2 or 3 thrombosis-related BVD (subclinical and clinical) occurred more frequently with TAVR (5.2% vs 0.9%; HR, 5.52; 95% CI, 1.92-15.85; P < .001), although most events occurred within 3 years and few progressed to BVF. Rates of stage 2 or 3 endocarditis-related BVD were also low and similar (0.4% in the TAVR group vs 0.5% in the surgery group; HR, 0.85; 95% CI, 0.12-6.07; P = .87). The proportion of patients alive and free of all-cause BVF was 73.4% (331/451) with TAVR vs 74.8% (288/385) with surgery (P = .69).
CONCLUSIONS AND RELEVANCE
In this ad hoc analysis of a randomized clinical trial among low-risk patients with symptomatic severe aortic stenosis randomized to TAVR or surgery, both TAVR and surgery demonstrated comparable and sustained valve durability, with low and similar rates of SVD, all-cause BVF, and reintervention through 7 years. These findings may inform discussions of valve replacement strategies.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02675114.
MeSH
Constriction, Pathologic, Aortic Valve Stenosis, Incidence, Cardiovascular Diseases, Endocarditis, Aortic Valve, Transcatheter Aortic Valve Replacement, Thrombosis, Surgical Aortic Valve Replacement