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EARLY TAVR

A trial in 901 people aged 65 or older with severe aortic stenosis but no symptoms. It compared early TAVR (with the SAPIEN 3 valve) against clinical surveillance. Fewer people in the TAVR group had a death, stroke or unplanned hospital stay. Death occurred in 8.4% and 9.2% of the two groups, and the abstract gives no test for it. It was paid for by Edwards Lifesciences, the applicant for the valve's US approval, and the registry lists no masking.

Also called EARLY TAVR · EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group, open-label trial of early TAVR (balloon-expandable valve) versus clinical surveillance. The registry records allocation as randomized, intervention model as parallel and masking as none.
Phase
Not applicable
Enrolled
  • 901 participants (enrolled count) (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, retrieved )
  • 901 patients (randomized count) (Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis, retrieved )
Sponsor
Funder
Registry
  • NCT NCT03042104
Started
(actual) (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, retrieved )
Primary completion
(actual) (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, retrieved )
Completion
(anticipated) (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, retrieved )
Countries
United States, Canada (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, retrieved )
Care setting
75 centers in the United States and Canada (abstract). (Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis, retrieved )
Registry status
  • “ACTIVE_NOT_RECRUITING” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Registry NCT03042104 (Edwards Lifesciences lead sponsor, class industry, status active but not recruiting, primary completion 2024-03-31 actual, estimated completion 2032-03). Randomized, parallel, no masking, treatment. Abstract: primary composite 26.8% versus 45.3% (hazard ratio 0.50); superiority testing in the intention-to-treat population. The registry has not posted results. Findings tabulated: death and stroke percentages only, because the composite and the hospitalization component have no outcome record in this atlas.

Arms

  • Early TAVR

    Intervention SAPIEN 3 transcatheter heart valve

    Transcatheter aortic valve replacement with the SAPIEN 3 or SAPIEN 3 Ultra valve (registry), balloon-expandable and placed through the femoral artery (abstract).

  • Clinical surveillance

    Intervention None named

    Clinical surveillance (registry arm label). 87.0% of this group later had aortic-valve replacement (abstract). No separate intervention record exists for this comparison.

Findings

Findings are grouped by the claim they support. Each group keeps its own population and follow-up, and each finding keeps its own denominator and time window. Not reported is not zero, and findings from different contexts are not combined.

In plain words

In EARLY TAVR, 901 patients with severe aortic stenosis and no symptoms were randomized to early TAVR with a balloon-expandable valve (455 patients) or to clinical surveillance (446 patients). A primary event (death, stroke or unplanned hospitalization for cardiovascular causes) occurred in 122 patients (26.8%) in the TAVR group and 202 (45.3%) in the surveillance group (hazard ratio 0.50, 95% confidence interval 0.40 to 0.63). Death occurred in 8.4% versus 9.2%. Strokes were 4.2% versus 6.7% and unplanned hospitalizations 20.9% versus 41.7%, in the TAVR and surveillance groups respectively. During a median follow-up of 3.8 years, 87.0% of the surveillance group had their aortic valve replaced.

Applies to Adult
  • Patients 65 years or older (registry minimum age) with asymptomatic severe aortic stenosis, 901 of whom were randomized at 75 centers in the United States and Canada. The abstract gives a mean age of 75.8 years, a mean Society of Thoracic Surgeons Predicted Risk of Mortality score of 1.8% and 83.6% of patients at low surgical risk. The detailed inclusion and exclusion criteria are in the registry record and were not extracted.
  • 75 centers in the United States and Canada (abstract)
  • United States and Canada
  • Registry minimum age 65 years; mean age 75.8 years (abstract)
Follow-up Median follow-up 3.8 years (abstract). The registry gives the primary completion as 2024-03-31 and an estimated study completion of 2032-03.

Death from any cause Endpoint role not specified

  1. Early TAVR arm

    Measure
    Death from any cause (percent of patients)
    Value
    8.4 percent
    Reported as
    8.4% of patients assigned to TAVR
    Interval
    Not applicable
    Denominator
    Not reported (basis: Percentage of the patients assigned to the group (455 assigned to TAVR and 446 to clinical surveillance, abstract). The abstract does not say whether the percentages are Kaplan-Meier estimates, and gives no event counts for this outcome.)
    Time window
    Median follow-up 3.8 years (abstract); the abstract does not give the time point of this percentage

  2. Clinical surveillance arm

    Measure
    Death from any cause (percent of patients)
    Value
    9.2 percent
    Reported as
    9.2% of patients assigned to clinical surveillance
    Interval
    Not applicable
    Denominator
    Not reported (basis: Percentage of the patients assigned to the group (455 assigned to TAVR and 446 to clinical surveillance, abstract). The abstract does not say whether the percentages are Kaplan-Meier estimates, and gives no event counts for this outcome.)
    Time window
    Median follow-up 3.8 years (abstract); the abstract does not give the time point of this percentage

Stroke as an outcome Endpoint role not specified

  1. Early TAVR arm

    Measure
    Stroke (percent of patients)
    Value
    4.2 percent
    Reported as
    4.2% of patients assigned to TAVR
    Interval
    Not applicable
    Denominator
    Not reported (basis: Percentage of the patients assigned to the group (455 assigned to TAVR and 446 to clinical surveillance, abstract). The abstract does not say whether the percentages are Kaplan-Meier estimates, and gives no event counts for this outcome.)
    Time window
    Median follow-up 3.8 years (abstract); the abstract does not give the time point of this percentage

  2. Clinical surveillance arm

    Measure
    Stroke (percent of patients)
    Value
    6.7 percent
    Reported as
    6.7% of patients assigned to clinical surveillance
    Interval
    Not applicable
    Denominator
    Not reported (basis: Percentage of the patients assigned to the group (455 assigned to TAVR and 446 to clinical surveillance, abstract). The abstract does not say whether the percentages are Kaplan-Meier estimates, and gives no event counts for this outcome.)
    Time window
    Median follow-up 3.8 years (abstract); the abstract does not give the time point of this percentage

Caveats

  • Limitations. Funded by Edwards Lifesciences, which the registry lists as lead sponsor. The registry lists no masking. Death occurred in 8.4% and 9.2% of the two groups, and the abstract gives no test for the individual components, so this record does not say whether the differences in death or stroke are meaningful. Most patients in the surveillance group (87.0%) later had their valve replaced, so the comparison is early replacement with a strategy after which most patients still had replacement. The percentages are not tied to a time point in the abstract. Only the abstract was read. The registry has no posted results yet.

Sources and citations (7)

  1. Supports Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

    Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

    Locator
    Abstract, RESULTS, sentence 3
    How it applies
    Primary event counts and rates, and the hazard ratio.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
    Reuse basis
    PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  2. Supports Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

    Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

    Locator
    Abstract, RESULTS, sentence 4
    How it applies
    Death, stroke and hospitalization percentages by group; the abstract gives no test.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
    Reuse basis
    PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  3. Supports Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

    Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

    Locator
    Abstract, RESULTS, sentence 5
    How it applies
    Share of the surveillance group who had valve replacement.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
    Reuse basis
    PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  4. Supports Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

    Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

    Locator
    Abstract, CONCLUSIONS, sentence 1
    How it applies
    The authors' conclusion for the same population.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
    Reuse basis
    PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  5. Background Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

    Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

    Locator
    Abstract, METHODS, sentences 1 to 3
    How it applies
    Design, centers and end point.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
    Reuse basis
    PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  6. Background Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis

    Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, fetched 2026-10-14. PubMed lists no PMC copy. The version of record was not fetched: the NEJM page returned HTTP 403 (a bot challenge page) when tried on 2026-10-14 for the PARTNER 3 paper, and the other NEJM papers were not tried. · Published 2025-01-16 · DOI: 10.1056/NEJMoa2405880 · PMID: 39466903

    Locator
    Abstract, RESULTS, sentences 1 and 2
    How it applies
    Number randomized, age and risk score.
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    7548b3c77ff8590b503c9cecc640c75b51bad95f0d795075c7ae0d955c133943
    Reuse basis
    PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (PubMed disclaimer, fetched 2026-10-14 as cj-pubmed-disclaimer.html, hash only). Short factual quotations under 25 words, with the citation. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) for PubMed and other NLM records.

  7. Background EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

    Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-05-13. · NCT: NCT03042104

    Locator
    protocolSection.designModule.designInfo.maskingInfo.masking
    How it applies
    The registry records no masking.
    Retrieved
    Source effective date
    2024-05-13
    Source state
    Current
    Snapshot hash
    c5b3fac506ff46da7da961337b6ae035819edd44091278e503e871285ae39d4f
    Reuse basis
    Registry record. The raw API JSON is committed at research/snapshots/cj-ctgov-NCT03042104.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.

Record details

Record id
cardio:early-tavr
Content hash
344442d0ad3910088116af11b707109ec3f6c712086f6af5afff4ff7529e9b8a