Valve Disease2019New England Journal of Medicine

PARTNER 3

Placement of Aortic Transcatheter Valves 3

Sample Size

1,000

Study Design

Multicenter, randomized, controlled, noninferiority trial

Year Published

2019

Clinical Question

Is transfemoral TAVR with a balloon-expandable valve noninferior to surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis at low surgical risk?

Population

Patients with severe aortic stenosis and an STS-PROM score below 4%, indicating low surgical risk, across 71 sites in the United States and Canada.

Intervention

Transfemoral TAVR with the SAPIEN 3 balloon-expandable valve

Control

Surgical aortic valve replacement (SAVR)

Primary Endpoint

Composite of death from any cause, stroke, or rehospitalization at 1 year

Key Findings

The primary composite endpoint occurred in 8.5% of TAVR patients vs 15.1% of surgery patients at 1 year (absolute difference -6.6 percentage points; 95% CI, -10.8 to -2.5).

All-cause mortality at 1 year was 1.0% with TAVR vs 2.5% with surgery.

Stroke rates were 1.2% in TAVR vs 3.1% in surgery at 30 days.

New-onset atrial fibrillation was significantly lower in the TAVR group (7.9% vs 35.4%).

Moderate or severe paravalvular regurgitation was higher with TAVR (0.8%) than surgery (0%) at 1 year.

Impact on Clinical Practice

PARTNER 3 fundamentally expanded the indication for TAVR to low-surgical-risk patients, a population that represents the largest segment of patients undergoing aortic valve replacement. Prior to this trial, TAVR had been reserved for patients deemed inoperable, high-risk, or intermediate-risk for surgery. The results showed that TAVR was not only noninferior but statistically superior to surgery for the primary composite endpoint at 1 year. This was driven by lower rates of death, stroke, and rehospitalization, along with dramatically lower rates of new-onset atrial fibrillation and shorter hospital stays. The trial, combined with the concurrent Evolut Low Risk trial, led to a paradigm shift in the management of aortic stenosis. It supported a shared decision-making model in which TAVR became a viable option across the entire risk spectrum, with FDA approval for low-risk patients granted in August 2019.

Guideline Impact

The 2020 ACC/AHA Guideline for the Management of Valvular Heart Disease incorporated PARTNER 3 data to recommend TAVR as an alternative to SAVR in patients at low surgical risk (Class 2a recommendation). The ESC/EACTS 2021 guidelines similarly recognized TAVR for patients aged 75 and older at low risk.

Limitations

Follow-up was limited to 1 year; longer-term valve durability data remain essential, particularly for younger low-risk patients.

The trial excluded patients with bicuspid aortic valves, which constitute a significant proportion of low-risk aortic stenosis patients.

The rate of permanent pacemaker implantation was not significantly different but trended higher with TAVR.

Reviewed by Sandeep M. Patel, MD

Structural & Interventional Cardiologist

How Does This Trial Apply to Your Case?

Clinical trials inform guidelines, but every patient is unique. Our Heart Team evaluates how landmark evidence applies to your specific anatomy, risk profile, and preferences.

Get a Second Opinion

Related Trials

PARTNER 1

2011 · New England Journal of Medicine

PARTNER 2

2016 · New England Journal of Medicine

Evolut Low Risk

2019 · New England Journal of Medicine

NOTION

2015 · Journal of the American Medical Association

SURTAVI

2017 · New England Journal of Medicine

aortic stenosis tavr vs savr

Stay informed.

Expert cardiac surgery insights from the WhiteGloveMD Heart Team, delivered to your inbox.

No spam. Unsubscribe anytime. HIPAA-compliant.