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New England Journal of Medicine· 2019Q1

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

Jeffrey J. Popma, G. Michael Deeb, Steven J. Yakubov, Mubashir Mumtaz et al.

Short summary

Transcatheter aortic-valve replacement (TAVR) with a self-expanding bioprosthesis is non-inferior to surgical aortic-valve replacement in low-risk patients with severe aortic stenosis, showing comparable rates of death or disabling stroke at 24 months.

AI-generated from the title and abstract; the full text is not read.

Key points

  • TAVR with a self-expanding supraannular bioprosthesis was compared to surgical aortic-valve replacement in low-risk patients with severe aortic stenosis.
  • The primary end point was a composite of death or disabling stroke at 24 months.
  • TAVR was non-inferior to surgery for this composite end point.
  • The trial included 850 patients who reached 12-month follow-up, with analysis focused on 24-month outcomes.

AI-generated from the title and abstract; the full text is not read.

Abstract

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: ). CONCLUSIONS: 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.).

The authors' abstract, as published at the source. New England Journal of Medicine, 2019 · DOI ↗

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Field: Cardiology and Cardiovascular Medicine

Cardiology and Cardiovascular MedicineMedicine