5-year outcomes after transcatheter or surgical aortic valve replacement in low-risk patients with aortic stenosis

Authors

John K. Forrest, Yale University School of Medicine, New Haven, Connecticut, USA. Electronic address: john.k.forrest@yale.edu.
Steven J. Yakubov, OhioHealth Riverside Methodist Hospital, Columbus, Ohio, USA.
G Michael Deeb, University of Michigan Health Systems University Hospital, Ann Arbor, Michigan, USA.
Hemal Gada, University of Pittsburgh Medical Center, Harrisburg, Pennsylvania, USA.
Mubashir A. Mumtaz, University of Pittsburgh Medical Center, Harrisburg, Pennsylvania, USA.
Basel Ramlawi, Lankenau Heart Institute, Philadelphia, Pennsylvania, USA.
Tanvir Bajwa, Advocate Health - MidwestFollow
John Crouch, Advocate Health - MidwestFollow
William Merhi, Corewell Health West, Grand Rapids, Michigan, USA.
Stephane Leung Wai Sang, Corewell Health West, Grand Rapids, Michigan, USA.
Neal S. Kleiman, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA.
George Petrossian, Saint Francis Hospital, Roslyn, New York, USA.
Newell B. Robinson, Saint Francis Hospital, Roslyn, New York, USA.
Paul Sorajja, Minneapolis Heart Institute-Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.
Ayman Iskander, Saint Joseph's Hospital Health Center, Syracuse, New York, USA.
Pierre Berthoumieu, Clinique Pasteur, Toulouse, France.
Didier Tchétché, Clinique Pasteur, Toulouse, France.
Christopher Feindel, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
Eric M. Horlick, Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada.
Shigeru Saito, Shonan Kamakura General Hospital, Kamakura, Kanagawa, Japan.
Jae K. Oh, Echocardiography Core Laboratory, Mayo Clinic, Rochester, Minnesota, USA.
Yoojin Jung, Medtronic, Minneapolis, Minnesota, USA.
Michael J. Reardon, Houston Methodist-DeBakey Heart and Vascular Center, Houston, Texas, USA.

Recommended Citation

Forrest JK, Yakubov SJ, Deeb GM, et al. 5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. J Am Coll Cardiol. 2025;85(15):1523-1532. doi:10.1016/j.jacc.2025.03.004

Abstract

Background: The Evolut Low Risk trial demonstrated that transcatheter aortic valve replacement (TAVR) was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. Outcomes at 5 years have not been reported.

Objectives: This study sought to evaluate 5-year clinical and hemodynamic outcomes with TAVR vs surgery in patients from the Evolut Low Risk trial.

Methods: We randomly assigned low-risk patients with severe aortic stenosis to TAVR or surgery. The primary endpoint was a composite of all-cause mortality or disabling stroke. Secondary endpoints included clinical, echocardiographic, and quality-of-life outcomes through 5 years.

Results: A total of 1,414 patients underwent an attempted implant (n = 730 TAVR, n = 684 surgery). The mean age was 74 years (range 51-88 years), and women accounted for 35% of patients. At 5 years the Kaplan-Meier estimate for the primary endpoint of all-cause mortality or disabling stroke was 15.5% for the TAVR group and 16.4% for the surgery group (P = 0.47). The Kaplan-Meier estimates in the TAVR and surgery groups for all-cause mortality were 13.5% and 14.9% (P = 0.39) and for disabling stroke were 3.6% and 4.0% (P = 0.57). Cardiovascular mortality was 7.2% in the TAVR group and 9.3% in the surgery group (P = 0.15). Noncardiovascular mortality in the TAVR group was 6.8% and 6.2% in the surgery group (P = 0.73). A site-level vital status sweep was performed for patients who were lost to follow-up or withdrew from the study. With the addition of these patients, the all-cause mortality rate at 5 years for patients undergoing TAVR was 14.7% and for surgery was 15.2% (P = 0.74). Over 5 years, valve reintervention rate was 3.3% for TAVR and 2.5% for surgery (P = 0.44). A sustained improvement in quality of life was observed in both treatment arms with mean Kansas City Cardiomyopathy Questionnaire summary score of 88.3 ± 15.8 in TAVR and 88.5 ± 15.8 in surgery.

Conclusions: At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke. Valve durability and performance were excellent in both arms. This midterm evaluation reinforces the position of TAVR as noninferior to surgery in patients with severe aortic stenosis at low surgical risk (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283 ).

Type

Article

PubMed ID

40158212