March 16, 2019Open Access

Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients

Key Result

TAVR with a self-expanding bioprosthesis was noninferior to surgery for death or disabling stroke at 24 months in low-risk patients with severe aortic stenosis.

Structured PICO

Does TAVR with a self-expanding bioprosthesis prevent the composite of death or disabling stroke compared to surgical aortic-valve replacement in patients with severe aortic stenosis at low surgical risk?

Population

1,468 patients with severe aortic stenosis at low surgical risk (predicted risk of death by 30 days with surgery ≤3%), mean age 74 years, 34.9% female, multinational (86 centers in 7 countries). Excluded candidates for mechanical valves and bicuspid aortic valves.

Intervention

Transcatheter aortic-valve replacement (TAVR) with a self-expanding, supraannular bioprosthesis (CoreValve, Evolut R, or Evolut PRO)

Comparator

Surgical aortic-valve replacement (size and type of surgical valve at the discretion of the surgeon, mechanical valves excluded)

Outcome

Composite of death from any cause or disabling stroke at 24 monthscomposite

In patients with severe aortic stenosis at low surgical risk, TAVR with a self-expanding bioprosthesis was noninferior to surgery for the composite of death or disabling stroke at 24 months.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

Expert Takes1 quote

“[The study] provides robust, long-term evidence supporting the use of balloon-expandable TAVR in appropriately selected low-risk patients and reinforces the current guideline recommendations.”

Medscape CardiologyView source

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