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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
Category
Valve Disease

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

1

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).

2

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

3

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

4

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

5

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

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