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Peer-reviewedCC BY-NC-NDJournal of the American College of Cardiology

10-Year Randomized Outcomes of Transcatheter or Surgical Aortic Valve Replacement in Intermediate-Risk Aortic Stenosis

  • Vinod H. Thourani1
  • Philipp von Stein2
  • Michael J. Mack3
  • Tamim M. Nazif4
  • Vasilis C. Babaliaros5
  • Mohamad Adnan Alkhouli6
  • Michael P. Fischbein7
  • Nimesh D. Desai8
  • Lowell Satler9
  • Frank J. Zidar10
  • Susheel Kodali4
  • Irving L. Kron11
13 more authors
  • Alan Zajarías12
  • W B Brinkman3
  • Samir Ramesh Kapadia13
  • Todd M. Dewey14
  • Mario Gössl15
  • Robert Mark Bodenhamer16
  • Ying Ma17
  • David J. Cohen18
  • Rahul Prakash Sharma19
  • Philippe Pîbarot20
  • Rebecca Tung Hahn21
  • Martin B. Leon21
  • Raj Makkar22
22 affiliations
  1. 1Piedmont Heart Institute, Atlanta, Georgia, USA. Electronic address: [email protected]
  2. 2Cardiovascular Research Foundation, New York, New York, USA
  3. 3The Heart Hospital Baylor Scott and White Plano, Plano, Texas, USA
  4. 4Division of Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, New York, USA
  5. 5Emory University Hospital, Atlanta, Georgia, USA
  6. 6Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA
  7. 7Stanford Department of Cardiothoracic Surgery, Stanford University School of Medicine, Stanford, California, USA
  8. 8Division of Cardiovascular Surgery, Department of Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA
  9. 9Section of Interventional Cardiology, Washington Hospital Center, Washington, DC, USA
  10. 10Austin Heart, Austin, Texas, USA
  11. 11Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia, USA
  12. 12Cardiovascular Division, Washington University/Barnes Jewish Hospital, St Louis, Missouri, USA
  13. 13Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA
  14. 14Medical City Dallas Hospital, Dallas, Texas, USA
  15. 15Valve Science Center, Allina Health Minneapolis Heart Institute, Minneapolis, Minnesota, USA
  16. 16University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, USA
  17. 17Edwards Lifesciences, Irvine, California, USA
  18. 18Cardiovascular Research Foundation, New York, New York, USA; St Francis Hospital and Heart Center, Roslyn, New York, USA
  19. 19Division of Cardiovascular Medicine, Stanford Health Care, Stanford, California, USA
  20. 20Quebec Heart & Lung Institute, Université Laval, Quebec, Quebec, Canada
  21. 21Cardiovascular Research Foundation, New York, New York, USA; Division of Cardiology, Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, New York, USA
  22. 22Cedars-Sinai Medical Center, Los Angeles, California, USA
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Abstract

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement for symptomatic severe aortic stenosis, but long-term, comparative clinical outcomes and echocardiography data are lacking. OBJECTIVES: Our goal was to compare 10-year clinical and echocardiographic outcomes after balloon-expandable TAVR or surgery in intermediate-risk surgical patients in the PARTNER 2A randomized trial. METHODS: Between 2011 and 2013, patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized at 57 centers to TAVR with the balloon-expandable SAPIEN XT system (Edwards Lifesciences) or to surgery. Randomization was stratified by anatomical suitability for transfemoral (TF) or transthoracic (transapical/transaortic [TA/TAo]) access. Ten-year outcomes were evaluated in the valve implant population and included all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. To obtain 10-year data, patient reconsent at 5 years was required, and vital status sweeps were implemented to improve data completeness for all-cause mortality. RESULTS: Among 1,910 randomized patients who received a valve, 974 underwent TAVR (TF: 749/974 [76.9%]) and 936 had surgery. Mean patient age was 81.6 years, 45.4% were women, and the mean Society of Thoracic Surgeons score was 5.8%. At 10 years, vital status was available for 881 of 974 patients (90.5%) and 838 of 936 patients (89.5%). All-cause 10-year mortality with vital status sweeps was 86.1% after TAVR and 82.8% after surgery (HR: 1.13; 95% CI: 1.02-1.25; P = 0.02). When stratified by access route, rates of all-cause mortality for TAVR and surgery in the TF group were similar (83.9% vs 82.1%, respectively; P = 0.27), whereas mortality was higher for TAVR in the TA/TAo group (93.2% vs 85.1%; P < 0.01; P for interaction = 0.03). Cumulative incidence rates of aortic valve reintervention at 10 years were 6.3% for TAVR and 1.6% for surgery (P < 0.001). Of the 24 TAVR and 35 surgical patients with available echocardiographic data at 10 years, mean gradients were 12.6 mm Hg and 12.7 mm Hg, respectively. CONCLUSIONS: At the 10-year follow-up, TAVR in intermediate-risk patients with the SAPIEN XT prosthesis compared with surgery was associated with lower survival rates, with differences predominantly observed in the TA/TAo access cohort. TAVR with the XT valve was also associated with significantly higher rates of aortic valve reintervention. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk [PII A]; NCT01314313).

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Cite

BibTeXRIS
BibTeX
@article{thourani202610year,
  title = {{10-Year Randomized Outcomes of Transcatheter or Surgical Aortic Valve Replacement in Intermediate-Risk Aortic Stenosis}},
  author = {Vinod H. Thourani and Philipp von Stein and Michael J. Mack and Tamim M. Nazif and Vasilis C. Babaliaros and Mohamad Adnan Alkhouli and Michael P. Fischbein and Nimesh D. Desai and Lowell Satler and Frank J. Zidar and Susheel Kodali and Irving L. Kron and Alan Zajarías and W B Brinkman and Samir Ramesh Kapadia and Todd M. Dewey and Mario Gössl and Robert Mark Bodenhamer and Ying Ma and David J. Cohen and Rahul Prakash Sharma and Philippe Pîbarot and Rebecca Tung Hahn and Martin B. Leon and Raj Makkar},
  journal = {Journal of the American College of Cardiology},
  year = {2026},
  month = jun,
  doi = {10.1016/j.jacc.2026.03.169},
  url = {https://doi.org/10.1016/j.jacc.2026.03.169},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - 10-Year Randomized Outcomes of Transcatheter or Surgical Aortic Valve Replacement in Intermediate-Risk Aortic Stenosis
AU  - Vinod H. Thourani
AU  - Philipp von Stein
AU  - Michael J. Mack
AU  - Tamim M. Nazif
AU  - Vasilis C. Babaliaros
AU  - Mohamad Adnan Alkhouli
AU  - Michael P. Fischbein
AU  - Nimesh D. Desai
AU  - Lowell Satler
AU  - Frank J. Zidar
AU  - Susheel Kodali
AU  - Irving L. Kron
AU  - Alan Zajarías
AU  - W B Brinkman
AU  - Samir Ramesh Kapadia
AU  - Todd M. Dewey
AU  - Mario Gössl
AU  - Robert Mark Bodenhamer
AU  - Ying Ma
AU  - David J. Cohen
AU  - Rahul Prakash Sharma
AU  - Philippe Pîbarot
AU  - Rebecca Tung Hahn
AU  - Martin B. Leon
AU  - Raj Makkar
PY  - 2026
DA  - 2026/06/01
JO  - Journal of the American College of Cardiology
DO  - 10.1016/j.jacc.2026.03.169
UR  - https://doi.org/10.1016/j.jacc.2026.03.169
AB  - BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an established alternative to surgical aortic valve replacement for symptomatic severe aortic stenosis, but long-term, comparative clinical outcomes and echocardiography data are lacking. OBJECTIVES: Our goal was to compare 10-year clinical and echocardiographic outcomes after balloon-expandable TAVR or surgery in intermediate-risk surgical patients in the PARTNER 2A randomized trial. METHODS: Between 2011 and 2013, patients with severe, symptomatic aortic stenosis at intermediate surgical risk were randomized at 57 centers to TAVR with the balloon-expandable SAPIEN XT system (Edwards Lifesciences) or to surgery. Randomization was stratified by anatomical suitability for transfemoral (TF) or transthoracic (transapical/transaortic [TA/TAo]) access. Ten-year outcomes were evaluated in the valve implant population and included all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. To obtain 10-year data, patient reconsent at 5 years was required, and vital status sweeps were implemented to improve data completeness for all-cause mortality. RESULTS: Among 1,910 randomized patients who received a valve, 974 underwent TAVR (TF: 749/974 [76.9%]) and 936 had surgery. Mean patient age was 81.6 years, 45.4% were women, and the mean Society of Thoracic Surgeons score was 5.8%. At 10 years, vital status was available for 881 of 974 patients (90.5%) and 838 of 936 patients (89.5%). All-cause 10-year mortality with vital status sweeps was 86.1% after TAVR and 82.8% after surgery (HR: 1.13; 95% CI: 1.02-1.25; P = 0.02). When stratified by access route, rates of all-cause mortality for TAVR and surgery in the TF group were similar (83.9% vs 82.1%, respectively; P = 0.27), whereas mortality was higher for TAVR in the TA/TAo group (93.2% vs 85.1%; P < 0.01; P for interaction = 0.03). Cumulative incidence rates of aortic valve reintervention at 10 years were 6.3% for TAVR and 1.6% for surgery (P < 0.001). Of the 24 TAVR and 35 surgical patients with available echocardiographic data at 10 years, mean gradients were 12.6 mm Hg and 12.7 mm Hg, respectively. CONCLUSIONS: At the 10-year follow-up, TAVR in intermediate-risk patients with the SAPIEN XT prosthesis compared with surgery was associated with lower survival rates, with differences predominantly observed in the TA/TAo access cohort. TAVR with the XT valve was also associated with significantly higher rates of aortic valve reintervention. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk [PII A]; NCT01314313).
SN  - 0735-1097
SN  - 1558-3597
ER  -