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

10-Year Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement or Surgery in Intermediate-Risk Patients

  • Tamim M. Nazif1
  • Matheus Simonato2
  • Raj Makkar3
  • Vinod H. Thourani4
  • Desai Nm5
  • Vasilis C. Babaliaros6
  • Kevin Greason7
  • Joshua D. Rovin8
  • Sergio Waxman9
  • Charles Davidson10
  • Dean J. Kereiakes11
  • Anuj Kumar Gupta12
17 more authors
  • Lowell Satler13
  • Richard Schwartz14
  • Samir Ramesh Kapadia15
  • SJ Wong16
  • Richard W. Smalling17
  • Mohammad Ghani18
  • Paul S. Teirstein19
  • Isaac George20
  • Srinivasa P. Potluri21
  • Molly Szerlip21
  • Ke Xu22
  • David J. Cohen23
  • Rahul Prakash Sharma24
  • Philippe Pîbarot25
  • Rebecca Tung Hahn26
  • Michael J. Mack21
  • Martin B. Leon26
26 affiliations
  1. 1Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, New York, USA. Electronic address: [email protected]
  2. 2Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, New York, USA. Electronic address: https://twitter.com/msimonatomd
  3. 3Cedars-Sinai Medical Center, Los Angeles, California, USA
  4. 4Piedmont Heart Institute, Atlanta, Georgia, USA
  5. 5University of Pennsylvania, Philadelphia, Pennsylvania, USA
  6. 6Emory University, Atlanta, Georgia, USA
  7. 7Mayo Clinic, Rochester, Minnesota, USA
  8. 8Morton Plant Hospital, Clearwater, Florida, USA
  9. 9Newark Beth Israel Medical Center, Newark, New Jersey, USA
  10. 10Northwestern University, Evanston, Illinois, USA
  11. 11The Christ Hospital and Lindner Research Center, Cincinnati, Ohio, USA
  12. 12University of Maryland, Baltimore, Maryland, USA
  13. 13Washington Hospital Center, Washington, District of Columbia, USA
  14. 14Winthrop University Hospital, Mineola, New York, USA
  15. 15Cleveland Clinic Foundation, Cleveland, Ohio, USA
  16. 16Weill Cornell Medicine, New York, New York, USA
  17. 17University of Texas and Memorial Hermann Heart and Vascular Institute-TMC, Houston, Texas, USA
  18. 18Oklahoma Cardiovascular Research Group, Oklahoma City, Oklahoma, USA
  19. 19Scripps Clinic, La Jolla, California, USA
  20. 20Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, New York, USA
  21. 21Baylor Scott and White The Heart Hospital Plano, Plano, Texas, USA
  22. 22Edwards Lifesciences, Irvine, California, USA
  23. 23St Francis Hospital, Roslyn, New York, USA; Cardiovascular Research Foundation, New York, New York, USA
  24. 24Stanford University, Stanford, California, USA
  25. 25Université Laval, Quebec, Quebec, Canada
  26. 26Columbia University Irving Medical Center/New York-Presbyterian Hospital, New York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA
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Abstract

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for patients with symptomatic severe aortic stenosis. However, long-term outcomes data are lacking for TAVR, particularly with newer-generation transcatheter heart valves. OBJECTIVES: The purpose of this study was to compare 10-year outcomes of intermediate-risk patients who underwent TAVR with the third-generation, balloon-expandable SAPIEN 3 valve in the PARTNER 2 SAPIEN 3 Intermediate-risk Registry (P2S3i) with those who underwent surgery in the PARTNER 2A (P2A) randomized trial. METHODS: Intermediate-risk patients were enrolled in the P2A trial from 2011 through 2013 and in the P2S3i registry in 2014. These prospective, multicenter studies used the same eligibility criteria and stratified patients based on suitability for transfemoral or transthoracic (transapical/transaortic) access. Ten-year outcomes were evaluated, including all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. Patient reconsent was required at 5 years for extended 10-year follow-up, and vital status sweeps were implemented to improve data completeness for all-cause mortality. To account for potential baseline differences and reduce confounding, P2S3i TAVR patients were propensity score-matched 1:1 to P2A surgical patients. RESULTS: Among 2,005 patients who received a valve, 1,069 underwent TAVR in P2S3i and 936 underwent surgery in P2A. After propensity score matching (N = 783 patients in each group), baseline characteristics were similar between groups: mean age was approximately 82 years, 43% were female, and mean Society of Thoracic Surgeons score was 5.5%. At 10 years, all-cause mortality rate was 83.4% after TAVR and 82.3% after surgery, respectively (HR: 1.01 [95% CI: 0.91-1.13]; P = 0.82). Aortic valve reintervention rates adjusted for competing mortality were 2.0% for TAVR and 1.9% for surgery (P = 0.47). Among 32 TAVR and 30 surgical patients with available echocardiographic data at 10 years, mean gradients were 11.0 mm Hg and 12.6 mm Hg, respectively. CONCLUSIONS: At 10 years, TAVR with the SAPIEN 3 valve and surgery resulted in similar rates of mortality and aortic valve reintervention, and similar hemodynamics in intermediate-risk patients with symptomatic severe aortic stenosis. This analysis highlights challenges associated with extended long-term follow-up of clinical trials, including differential loss to follow-up and the competing risk of mortality in elderly populations. (PARTNER 2A Trial; NCT01314313; PARTNER 2 SAPIEN 3 Intermediate-Risk Registry; NCT03222128).

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Cite

BibTeXRIS
BibTeX
@article{nazif202610year,
  title = {{10-Year Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement or Surgery in Intermediate-Risk Patients}},
  author = {Tamim M. Nazif and Matheus Simonato and Raj Makkar and Vinod H. Thourani and Desai Nm and Vasilis C. Babaliaros and Kevin Greason and Joshua D. Rovin and Sergio Waxman and Charles Davidson and Dean J. Kereiakes and Anuj Kumar Gupta and Lowell Satler and Richard Schwartz and Samir Ramesh Kapadia and SJ Wong and Richard W. Smalling and Mohammad Ghani and Paul S. Teirstein and Isaac George and Srinivasa P. Potluri and Molly Szerlip and Ke Xu and David J. Cohen and Rahul Prakash Sharma and Philippe Pîbarot and Rebecca Tung Hahn and Michael J. Mack and Martin B. Leon},
  journal = {Journal of the American College of Cardiology},
  year = {2026},
  month = jun,
  doi = {10.1016/j.jacc.2026.03.170},
  url = {https://doi.org/10.1016/j.jacc.2026.03.170},
  note = {CC BY-NC-ND},
}
RIS
TY  - JOUR
TI  - 10-Year Outcomes of SAPIEN 3 Transcatheter Aortic Valve Replacement or Surgery in Intermediate-Risk Patients
AU  - Tamim M. Nazif
AU  - Matheus Simonato
AU  - Raj Makkar
AU  - Vinod H. Thourani
AU  - Desai Nm
AU  - Vasilis C. Babaliaros
AU  - Kevin Greason
AU  - Joshua D. Rovin
AU  - Sergio Waxman
AU  - Charles Davidson
AU  - Dean J. Kereiakes
AU  - Anuj Kumar Gupta
AU  - Lowell Satler
AU  - Richard Schwartz
AU  - Samir Ramesh Kapadia
AU  - SJ Wong
AU  - Richard W. Smalling
AU  - Mohammad Ghani
AU  - Paul S. Teirstein
AU  - Isaac George
AU  - Srinivasa P. Potluri
AU  - Molly Szerlip
AU  - Ke Xu
AU  - David J. Cohen
AU  - Rahul Prakash Sharma
AU  - Philippe Pîbarot
AU  - Rebecca Tung Hahn
AU  - Michael J. Mack
AU  - Martin B. Leon
PY  - 2026
DA  - 2026/06/01
JO  - Journal of the American College of Cardiology
DO  - 10.1016/j.jacc.2026.03.170
UR  - https://doi.org/10.1016/j.jacc.2026.03.170
AB  - BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement for patients with symptomatic severe aortic stenosis. However, long-term outcomes data are lacking for TAVR, particularly with newer-generation transcatheter heart valves. OBJECTIVES: The purpose of this study was to compare 10-year outcomes of intermediate-risk patients who underwent TAVR with the third-generation, balloon-expandable SAPIEN 3 valve in the PARTNER 2 SAPIEN 3 Intermediate-risk Registry (P2S3i) with those who underwent surgery in the PARTNER 2A (P2A) randomized trial. METHODS: Intermediate-risk patients were enrolled in the P2A trial from 2011 through 2013 and in the P2S3i registry in 2014. These prospective, multicenter studies used the same eligibility criteria and stratified patients based on suitability for transfemoral or transthoracic (transapical/transaortic) access. Ten-year outcomes were evaluated, including all-cause mortality, aortic valve reintervention, and core laboratory-adjudicated echocardiographic outcomes. Patient reconsent was required at 5 years for extended 10-year follow-up, and vital status sweeps were implemented to improve data completeness for all-cause mortality. To account for potential baseline differences and reduce confounding, P2S3i TAVR patients were propensity score-matched 1:1 to P2A surgical patients. RESULTS: Among 2,005 patients who received a valve, 1,069 underwent TAVR in P2S3i and 936 underwent surgery in P2A. After propensity score matching (N = 783 patients in each group), baseline characteristics were similar between groups: mean age was approximately 82 years, 43% were female, and mean Society of Thoracic Surgeons score was 5.5%. At 10 years, all-cause mortality rate was 83.4% after TAVR and 82.3% after surgery, respectively (HR: 1.01 [95% CI: 0.91-1.13]; P = 0.82). Aortic valve reintervention rates adjusted for competing mortality were 2.0% for TAVR and 1.9% for surgery (P = 0.47). Among 32 TAVR and 30 surgical patients with available echocardiographic data at 10 years, mean gradients were 11.0 mm Hg and 12.6 mm Hg, respectively. CONCLUSIONS: At 10 years, TAVR with the SAPIEN 3 valve and surgery resulted in similar rates of mortality and aortic valve reintervention, and similar hemodynamics in intermediate-risk patients with symptomatic severe aortic stenosis. This analysis highlights challenges associated with extended long-term follow-up of clinical trials, including differential loss to follow-up and the competing risk of mortality in elderly populations. (PARTNER 2A Trial; NCT01314313; PARTNER 2 SAPIEN 3 Intermediate-Risk Registry; NCT03222128).
SN  - 0735-1097
SN  - 1558-3597
ER  -