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Meta-Analysis
. 2025 Nov 1;10(11):1175-1185.
doi: 10.1001/jamacardio.2025.3403.

Transcatheter or Surgical Treatment of Patients With Aortic Stenosis at Low to Intermediate Risk: An Individual Participant Data Meta-Analysis

Sebastian Ludwig  1   2   3   4 , Matthias Klimek  5 , Benjamin Bay  1   2   3 , Stefan Blankenberg  1   2   3   5 , Juan F Granada  4 , David Hildick-Smith  6 , Jemma Hudson  7 , Troels Højsgaard Jørgensen  8 , Martin B Leon  4   9 , Christina Magnussen  1   2   3 , Holger Thiele  3   10 , Hans Gustav Hørsted Thyregod  8 , Olaf Wendler  11 , Ole de Backer  8 , William D Toff  12   13 , Andreas Ziegler  1   2   5   14 , Moritz Seiffert  3   15
Affiliations
Meta-Analysis

Transcatheter or Surgical Treatment of Patients With Aortic Stenosis at Low to Intermediate Risk: An Individual Participant Data Meta-Analysis

Sebastian Ludwig et al. JAMA Cardiol. .

Abstract

Importance: Mounting evidence suggests transcatheter aortic valve implantation (TAVI) as preferred treatment for patients at low to intermediate surgical risk. However, limitations in study design and statistical power raise concerns about the generalizability of individual randomized clinical trials (RCTs) comparing TAVI and surgical aortic valve replacement (SAVR) to routine clinical practice.

Objective: To compare 1-year outcomes of TAVI vs SAVR in patients with severe symptomatic aortic stenosis at low to intermediate surgical risk applying a 2-stage individual participant data (IPD) and aggregate meta-analyses.

Data sources: MEDLINE databases were searched for RCTs comparing TAVI and SAVR in patients with aortic stenosis until June 15, 2025.

Study selection: RCTs were selected comparing TAVI vs SAVR in patients with severe symptomatic aortic stenosis at low or intermediate surgical risk with 1-year follow-up.

Data extraction and synthesis: IPD were obtained from all investigator-initiated RCTs (DEDICATE, NOTION, NOTION-2, and UK TAVI) and analyzed in 1- and 2-stage IPD meta-analyses. An overall meta-analysis was performed by adding aggregate data from industry-sponsored RCTs.

Main outcomes and measures: The primary end point was all-cause death or any stroke 1 year after randomization. Secondary end points included all-cause death, any stroke, disabling stroke, cardiovascular death, rehospitalization for cardiovascular cause, myocardial infarction, new-onset atrial fibrillation, new permanent pacemaker implantation, and aortic valve reintervention.

Results: The IPD meta-analysis included 4 RCTs comprising 2873 patients (mean [SD] age, 76.7 [5.5] years; 805 [56.1%] male) at low to intermediate surgical risk randomly assigned to TAVI (n = 1439) or SAVR (n = 1434). At 1 year, the hazard ratio (HR) for the primary end point for TAVI compared to SAVR was 0.73 (95% CI, 0.56-0.95) in the 1-stage and 0.79 (95% CI, 0.49-1.27) in the 2-stage IPD meta-analysis. In the 2-stage overall meta-analysis the HR for the primary end point was 0.76 (95% CI, 0.60-0.97).

Conclusions and relevance: In this IPD meta-analysis of 4 RCTs, and an overall meta-analysis of 8 RCTs of patients with severe symptomatic AS at low to intermediate risk, TAVI was associated with a reduction in the 1-year incidence of all-cause death or any stroke. These findings emphasize TAVI as alternative option in patients at low to intermediate risk. Long-term follow-up is warranted to evaluate sustainability of these findings.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Ludwig reported grants from 4C Medical and German Heart Foundation, personal fees from Abbott and Bayer, travel support from Edwards Lifesciences and Shockwave Medical outside the submitted work. Dr Klimek reported working as a biostatistician at Cardio-CARE, which is a 100% nonprofit stock company and a 100% daughter of the Kühne Foundation and Cardio-CARE is shareholder of ART-EMIS Hamburg, outside the submitted work. Dr Bay reported grants from Gertraud und Heinz Rose-Stiftung and from the German Heart Foundation outside the submitted work. Dr Granada reported CRO Services for Edwards Lifesciences, Medtronic, and Abbott during the conduct of the study. Dr Hudson reported grants from National Institute for Health Research Health Technology Assessment Programme. Additional support was provided by the National Institute for Health Research Clinical Research Network NIHR HTA and National Institute for Health Research Clinical Research Network funded this research during the conduct of the study. Dr Leon reported grants from Abbott, Boston Scientific, Edwards, and Medtronic and equity in Medinol, Concept, Xenter, and Ancora outside the submitted work. Dr Magnussen reported personal fees from Edwards, AstraZeneca, Novartis, Boehringer Ingelheim/Lilly, Bayer, and Novo Nordisk and grants from German Center for Cardiovascular Research, German Foundation for cardiovascular research, NDD, and Schwiete Foundation outside the submitted work. Dr De Backer reported personal fees from Abbott, Boston Scientific, and Medtronic during the conduct of the study. Dr Toff reported The University of Leicester received grant funding from the National Institute for Health Research for the conduct of the UK TAVI trial. Dr Ziegler reported serving as scientific director and CEO at Cardio-CARE, which is shareholder of ART-EMIS Hamburg, outside the submitted work. Dr Seiffert reported grants from German Center for Cardiovascular Research and German Heart Foundation during the conduct of the study and lecture fees from Abbott Vascular, Amgen, AstraZeneca, Bayer, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Inari Medical, Medtronic, Pfizer, Shockwave Medical, and Siemens Healthineers outside the submitted work. No other disclosures were reported.

References

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    1. Toff WD, Hildick-Smith D, Kovac J, et al. ; UK TAVI Trial Investigators . Effect of transcatheter aortic valve implantation vs surgical aortic valve replacement on all-cause mortality in patients with aortic stenosis: a randomized clinical trial. JAMA. 2022;327(19):1875-1887. doi: 10.1001/jama.2022.5776 - DOI - PMC - PubMed
    1. Jørgensen TH, Thyregod HGH, Savontaus M, et al. ; NOTION-2 investigators . Transcatheter aortic valve implantation in low-risk tricuspid or bicuspid aortic stenosis: the NOTION-2 trial. Eur Heart J. 2024;45(37):3804-3814. doi: 10.1093/eurheartj/ehae331 - DOI - PubMed

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