# EARLY TAVR

Study · id `cardio:early-tavr` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

> General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here.

The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations.

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

Browse, organ or system: Heart  
Browse, condition area: Valve and congenital heart disease  

## In plain language

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.

## 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.

## Key facts

- 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, snapshot `cardio:ctgov-nct03042104-2026-10-14`, retrieved 2026-10-14); 901 patients (randomized count; Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis, snapshot `cardio:pubmed-39466903-2026-10-14`, retrieved 2026-10-14)
- Started: 2017-07-12 (actual) (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, snapshot `cardio:ctgov-nct03042104-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2024-03-31 (actual) (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, snapshot `cardio:ctgov-nct03042104-2026-10-14`, retrieved 2026-10-14)
- Completion: 2032-03 (anticipated) (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, snapshot `cardio:ctgov-nct03042104-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; Canada (EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis, snapshot `cardio:ctgov-nct03042104-2026-10-14`, retrieved 2026-10-14)
- Care setting: 75 centers in the United States and Canada (abstract). (Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis, snapshot `cardio:pubmed-39466903-2026-10-14`, retrieved 2026-10-14)
- Registry status: "ACTIVE\_NOT\_RECRUITING" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct03042104-2026-10-14`, retrieved 2026-10-14)

## Study 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.

### 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.

Claim `cardio:claim-early-tavr-primary`.

Applies to: Recipient: Adult; Population: 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.; Care setting: 75 centers in the United States and Canada (abstract); Geography: United States and Canada; Life stage: 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.

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.

- Death from any cause (Not specified): Death from any cause (percent of patients) 8.4 percent; reported as "8.4% of patients assigned to TAVR"; arm Early TAVR, no comparator arm; 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
- Death from any cause (Not specified): Death from any cause (percent of patients) 9.2 percent; reported as "9.2% of patients assigned to clinical surveillance"; arm Clinical surveillance, no comparator arm; 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 (Not specified): Stroke (percent of patients) 4.2 percent; reported as "4.2% of patients assigned to TAVR"; arm Early TAVR, no comparator arm; 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 (Not specified): Stroke (percent of patients) 6.7 percent; reported as "6.7% of patients assigned to clinical surveillance"; arm Clinical surveillance, no comparator arm; 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

## Connected pages

- Registry arm label: TAVR: Transcatheter aortic valve replacement (TAVR) (`cardio:tavr`)
- Registry intervention: SAPIEN 3 / SAPIEN 3 Ultra: SAPIEN 3 transcatheter heart valve (`cardio:sapien-3`)
- Registry condition: severe aortic stenosis: Aortic stenosis (`cardio:aortic-stenosis`)
- Part of the primary outcome measure: Death from any cause (`core:outcome-death-any-cause`)
- Part of the primary outcome measure: Stroke as an outcome (`core:outcome-stroke`)
- Lead sponsor on the registry record: Edwards Lifesciences (`cardio:edwards-lifesciences`)
- Funder named in the abstract: Edwards Lifesciences (`cardio:edwards-lifesciences`)

## Provenance

Content hash: 344442d0ad3910088116af11b707109ec3f6c712086f6af5afff4ff7529e9b8a
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-14