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Valve Disease2017New England Journal of Medicine

SURTAVI

Surgical Replacement and Transcatheter Aortic Valve Implantation

Sample Size
1,660
Study Design
Multicenter, international, randomized, noninferiority trial with Bayesian analysis
Year Published
2017
Category
Valve Disease

Clinical Question

Is TAVR with a self-expanding bioprosthetic valve noninferior to SAVR in patients with severe aortic stenosis at intermediate surgical risk?

Population

Patients with severe symptomatic aortic stenosis and an STS-PROM score of 3-15% (mean 4.4%), indicating intermediate surgical risk, at 87 centers in the United States, Canada, and Europe.

Intervention

TAVR with the CoreValve or Evolut R self-expanding valve

Control

Surgical aortic valve replacement (SAVR)

Primary Endpoint

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

Key Findings

1

The primary endpoint occurred in 12.6% of TAVR vs 14.0% of SAVR patients at 24 months (posterior probability of noninferiority >0.999).

2

All-cause mortality at 24 months was 6.7% with TAVR vs 6.8% with SAVR.

3

Disabling stroke was 2.6% with TAVR vs 4.5% with SAVR at 24 months.

4

Permanent pacemaker implantation was higher with TAVR (25.9% vs 6.6%).

5

Acute kidney injury was lower with TAVR (1.7% vs 4.4%), and new-onset atrial fibrillation was much lower (12.9% vs 43.4%).

Impact on Clinical Practice

SURTAVI complemented PARTNER 2 by demonstrating that the benefit of TAVR in intermediate-risk patients was a class effect, extending to self-expanding as well as balloon-expandable valve platforms. The trial's Bayesian analysis conclusively demonstrated noninferiority with a posterior probability exceeding 0.999. The trial reinforced key advantages of TAVR over surgery, including lower rates of acute kidney injury, bleeding, and new-onset atrial fibrillation. However, the persistently higher rate of permanent pacemaker implantation with the self-expanding valve remained a concern, particularly in intermediate-risk patients with longer life expectancies. SURTAVI, together with PARTNER 2, provided the evidence base for expanding TAVR to intermediate-risk patients, which significantly broadened the eligible patient population and accelerated the growth of structural heart programs worldwide.

Guideline Impact

SURTAVI contributed to the 2017 ACC/AHA Focused Update that recommended TAVR as a reasonable alternative to SAVR in intermediate-risk patients (Class IIa). It was particularly important for establishing the self-expanding valve platform as a viable option in this risk category.

Limitations

High permanent pacemaker rate (25.9%) with the self-expanding valve may offset some of the benefits of TAVR, particularly regarding long-term ventricular function.

Bayesian analysis methodology, while rigorous, differs from conventional frequentist approaches and may complicate cross-trial comparisons.

Moderate or severe paravalvular regurgitation was more common with TAVR, though rates were low (3.4% at 1 year).

Reviewed by Farhan Ayubi, DO
Vascular & Endovascular Surgeon

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