Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients

Jeffrey J. Popma, G. Michael Deeb, Steven J. Yakubov, Mubashir Mumtaz, Hemal Gada, Daniel O’Hair, Tanvir Bajwa, John C. Heiser, William Merhi, Neal S. Kleiman, Judah Askew, Paul Sorajja, Joshua Rovin, Stanley J. Chetcuti, David H. Adams, Paul S. Teirstein, George L. Zorn, John K. Forrest, Didier Tchétché, Jon ResarAntony Walton, Nicolo Piazza, Basel Ramlawi, Newell Robinson, George Petrossian, Thomas G. Gleason, Jae K. Oh, Michael J. Boulware, Hongyan Qiao, Andrew S Mugglin, Michael J. Reardon

Research output: Contribution to journalArticlepeer-review

1666 Scopus citations

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: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm 2 vs. 2.0 cm 2).

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.).

Original languageEnglish (US)
Pages (from-to)1706-1715
Number of pages10
JournalNew England Journal of Medicine
Volume380
Issue number18
DOIs
StatePublished - May 2 2019

Bibliographical note

Publisher Copyright:
Copyright © 2019 Massachusetts Medical Society.

Keywords

  • Aged
  • Aortic Valve/surgery
  • Aortic Valve Insufficiency/etiology
  • Aortic Valve Stenosis/complications
  • Atrial Fibrillation/etiology
  • Bayes Theorem
  • Bioprosthesis
  • Echocardiography
  • Female
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation/adverse effects
  • Humans
  • Kaplan-Meier Estimate
  • Length of Stay
  • Male
  • Postoperative Complications/epidemiology
  • Prosthesis Design
  • Risk Factors
  • Stroke/etiology
  • Transcatheter Aortic Valve Replacement/adverse effects

PubMed: MeSH publication types

  • Equivalence Trial
  • Research Support, Non-U.S. Gov't
  • Randomized Controlled Trial
  • Multicenter Study
  • Journal Article
  • Comparative Study

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