Transcatheter vs Surgical Aortic Valve Replacement in Lower-Risk Patients: An Updated Meta-Analysis of Randomized Controlled Trials
- PMID: 40044297
- DOI: 10.1016/j.jacc.2024.12.031
Transcatheter vs Surgical Aortic Valve Replacement in Lower-Risk Patients: An Updated Meta-Analysis of Randomized Controlled Trials
Abstract
Background: Longer-term outcomes are especially important for lower-risk patients with severe aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). Additional randomized data comparing TAVR and SAVR have recently become available.
Objectives: The purpose of this study was to perform an updated systematic review with conventional pairwise meta-analyses and pooled survival analyses using reconstructed time-to-event individual participant data (IPD) including the totality of randomized evidence comparing longer-term clinical outcomes after TAVR and SAVR in lower-risk patients.
Methods: The prespecified primary endpoint was all-cause death. Key secondary endpoints included stroke and the composite of death or disabling stroke. Cox proportional hazards frailty regression and restricted mean survival time models were fitted using reconstructed time-to-event IPD. In sensitivity analyses, proportional odds models were fitted with frailty terms. Conventional pairwise meta-analyses were performed under random and fixed effects assumptions.
Results: Six trials enrolling 5,341 lower-risk patients were included with 2,717 randomized to TAVR and 2,624 randomized to SAVR (weighted mean follow-up of 35.7 months). At 5 years in the pooled survival analyses of reconstructed time-to-event IPD, TAVR was associated with a 20% reduction in the hazard of all-cause death (HR: 0.80; 95% CI: 0.66-0.97; P = 0.02) and a 19% reduction in the hazard of all-cause death or disabling stroke (HR: 0.81; 95% CI: 0.68-0.96; P = 0.01) compared with SAVR. There was no difference in stroke (HR: 0.97; 95% CI: 0.74-1.26; P = 0.80).
Conclusions: In lower-risk patients, TAVR was associated with a reduced hazard of death and death or disabling stroke compared with SAVR, while rates of stroke were equivalent. Most patients have not yet undergone 5-year follow-up, and so these findings may change as further longer-term data become available. The present data are informative for lower-risk patients and treating clinicians, but further randomized trials and longer-term follow-up are required, particularly in younger patients.
Keywords: aortic surgery; aortic valve replacement; meta-analysis; randomized controlled trials; transcatheter aortic valve implantation.
Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures Dr Reddy is funded by the Nuffield Department of Population Health, University of Oxford. Dr Howard is funded by the British Heart Foundation (FS/ICRF/22/26039). Dr Mack has served as a co-principal investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr Reardon has served as national surgical Principal Investigator on SURTAVR, Evolut Low-Risk, Reprise III, Acurate, Portico NG, and Vantage; and has received research support from Medtronic, Boston Scientific, Abbott Medical, and Gore. Dr Vora is a consultant for Medtronic. Dr Makkar has received research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific; has served as national Principal Investigator for Portico (Abbott) and Acurate (Boston Scientific) U.S. investigation device exemption trials; has received personal proctoring fees from Edwards Lifesciences; and has received travel support from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Forrest is a consultant for Edwards Lifesciences and Medtronic; and receives grant support from Edwards Lifesciences and Medtronic. Dr Leon has received research support to his institution from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott; has served on Advisory Boards for Medtronic, Boston Scientific, Gore, Meril Lifescience, and Abbott; and has served as the Co-Principal Investigator of the PARTNER 3 trial (Edwards Lifesciences, no direct compensation). Dr Ahmad has served as a consultant for Cardiovascular Systems Inc and Shockwave; and has served on the Medical Advisory Board of Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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