Valve Disease2019New England Journal of Medicine

Evolut Low Risk

Medtronic Evolut Transcatheter Aortic Valve Replacement in Low-Risk Patients

Sample Size

1,468

Study Design

Multicenter, randomized, noninferiority trial with Bayesian analysis

Year Published

2019

Clinical Question

Is TAVR with a self-expanding supraannular valve noninferior to surgery in patients with severe aortic stenosis at low surgical risk?

Population

Patients with severe symptomatic aortic stenosis and an STS-PROM score below 3%, indicating low surgical risk, at 86 sites worldwide.

Intervention

TAVR with the Medtronic CoreValve Evolut R or Evolut PRO self-expanding valve

Control

Surgical aortic valve replacement (SAVR)

Primary Endpoint

Composite of all-cause mortality or disabling stroke at 24 months

Key Findings

The primary endpoint of death or disabling stroke occurred in 5.3% of TAVR patients vs 6.7% of surgery patients at 24 months (posterior probability of noninferiority >0.999).

At 30 days, disabling stroke was 0.5% with TAVR vs 1.7% with surgery.

New permanent pacemaker implantation was higher with TAVR (17.4% vs 6.1%).

Mean aortic valve gradients at 12 months were lower with the self-expanding TAVR valve (8.6 mmHg) compared with surgery (11.2 mmHg).

New-onset atrial fibrillation was dramatically lower with TAVR (7.7% vs 35.4%).

Impact on Clinical Practice

The Evolut Low Risk trial, published simultaneously with PARTNER 3, provided complementary evidence supporting TAVR expansion to low-risk patients using a different valve platform. While PARTNER 3 used a balloon-expandable valve, this trial demonstrated similar results with a self-expanding design, confirming that the benefit was a class effect rather than device-specific. The superior hemodynamic profile of the self-expanding valve, with lower mean gradients, raised important questions about long-term valve performance and patient-prosthesis mismatch. However, the higher rate of permanent pacemaker implantation with the self-expanding valve remained a significant concern. Together with PARTNER 3, this trial led to FDA approval of TAVR for low-risk patients in August 2019 and catalyzed a global shift toward transcatheter-first strategies for aortic stenosis across the entire surgical risk spectrum.

Guideline Impact

Combined with PARTNER 3, this trial supported the 2020 ACC/AHA guideline recommendations for TAVR as an alternative to surgery in appropriately selected low-risk patients (Class 2a recommendation), with emphasis on shared decision-making and Heart Team evaluation.

Limitations

The higher rate of permanent pacemaker implantation (17.4%) with the self-expanding valve raises concerns about long-term right ventricular pacing effects.

Bayesian design methodology differed from conventional frequentist analysis, which may complicate direct comparisons with other trials.

Bicuspid aortic valve patients were excluded, and younger patients (<65) were underrepresented.

Reviewed by Callistus Ditah, MD

Surgery of the Aorta & Great Vessels

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.

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Related Trials

PARTNER 3

2019 · New England Journal of Medicine

PARTNER 1

2011 · New England Journal of Medicine

PARTNER 2

2016 · New England Journal of Medicine

SURTAVI

2017 · New England Journal of Medicine

NOTION

2015 · Journal of the American Medical Association

aortic stenosis tavr vs savr

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