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5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

Thursday, April 24, 2025

Submitted by

Mateo Marin-Cuartas

Source

Source Name: Journal of the American College of Cardiology

Source URL: https://www.jacc.org/doi/10.1016/j.jacc.2025.03.004

Author(s)

John K. Forrest, Steven J. Yakubov, G. Michael Deeb, Hemal Gada, Mubashir A. Mumtaz, Basel Ramlawi, Tanvir Bajwa, John Crouch, William Merhi, Stephane Leung Wai Sang, Neal S. Kleiman, George Petrossian, Newell B. Robinson, Paul Sorajja, Ayman Iskander, Pierre Berthoumieu, Didier Tchétché, Christopher Feindel, Eric M. Horlick, Shigeru Saito, Jae K. Oh, Yoojin Jung, Michael J. Reardon

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 two years. In this new publication, the authors report the five-year outcomes of the Evolut Low Risk trial. In this trial, low-risk patients with severe aortic stenosis were randomly assigned 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 five years.

A total of 1,414 patients underwent attempted valve implantation (n = 730 for TAVR, n = 684 for surgery). The mean age was 74 years (range 51-88 years), and women accounted for 35 percent of the patients. At five years, the Kaplan-Meier estimate for the primary endpoint of all-cause mortality or disabling stroke was 15.5 percent for the TAVR group and 16.4 percent for the surgery group (P = 0.47). The Kaplan-Meier estimates in the TAVR and surgery groups for all-cause mortality were 13.5 percent and 14.9 percent (P = 0.39) and for disabling stroke were 3.6 percent and 4.0 percent (P = 0.57). Cardiovascular mortality was 7.2 percent in the TAVR group and 9.3 percent in the surgery group (P = 0.15). Noncardiovascular mortality in the TAVR group was 6.8 percent and 6.2 percent 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 five years for patients undergoing TAVR was 14.7 percent, and for surgery, it was 15.2 percent (P = 0.74). Over five years, the valve reintervention rate was 3.3 percent for TAVR and 2.5 percent for surgery (P = 0.44). A sustained improvement in quality of life was observed in both treatment arms, with a mean Kansas City Cardiomyopathy Questionnaire summary score of 88.3 plus or minus 15.8 in TAVR and 88.5 plus or minus 15.8 in surgery.