Evidence map›Paper›PMID 40884787›Full record

SynthesisJAMA cardiology2025

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

Sebastian Ludwig, Matthias Klimek, Benjamin Bay, Stefan Blankenberg, Juan F Granada, David Hildick-Smith, Jemma Hudson, Troels Højsgaard Jørgensen, Martin B Leon, Christina Magnussen and 7 more

Abstract readMeta-Analysis
In one paragraph

Synthesis in JAMA cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Sebastian LudwigDepartment of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Matthias KlimekCardio-CARE, Medizincampus Davos, Davos, Switzerland.
Benjamin BayDepartment of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Stefan BlankenbergDepartment of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Juan F GranadaCardiovascular Research Foundation, New York, New York.
David Hildick-SmithSussex Cardiac Centre, Brighton and Sussex University Hospitals National Health Service Trust, Brighton, United Kingdom.
Jemma HudsonAberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, United Kingdom.
Troels Højsgaard JørgensenRigshospitalet, Copenhagen, Denmark.
Martin B LeonCardiovascular Research Foundation, New York, New York.
Christina MagnussenDepartment of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Holger ThieleGerman Centre for Cardiovascular Research Partner Site North, Hamburg/Kiel/Lübeck, Germany.
Hans Gustav Hørsted ThyregodRigshospitalet, Copenhagen, Denmark.
Olaf WendlerCleveland Clinic, London, United Kingdom.
Ole de BackerRigshospitalet, Copenhagen, Denmark.
William D ToffDepartment of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.
Andreas ZieglerDepartment of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Moritz SeiffertGerman Centre for Cardiovascular Research Partner Site North, Hamburg/Kiel/Lübeck, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Aortic Valve StenosisHeart Valve Prosthesis ImplantationTranscatheter Aortic Valve ReplacementAortic ValveHumansPostoperative ComplicationsRandomized Controlled Trials as TopicRisk AssessmentTreatment Outcome

Identifiers

PMID40884787
PMCPMC12398772

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.