Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients

Michael J Reardon, Nicolas M Van Mieghem, Jeffrey J. Popma, Neal S Kleiman, Lars Søndergaard, Mubashir Mumtaz, David H. Adams, G. Michael Deeb, Brijeshwar Maini, Hemal Gada, Stanley J. Chetcuti, Thomas G. Gleason, John Heiser, Rüdiger Lange, William Merhi, Jae K. Oh, Peter S Olsen, Nicolo Piazza, Mathew Williams, Stephan WindeckerSteven J. Yakubov, Eberhard Grube, Raj R. Makkar, Joon Sup Lee, John Conte, Eric Vang, Hang Nguyen, Yanping Chang, Andrew S Mugglin, Patrick W J C Serruys, Arie P Kappetein, SURTAVI Investigators

Research output: Contribution to journalArticlepeer-review

1370 Scopus citations

Abstract

BACKGROUND: Although transcatheter aortic-valve replacement (TAVR) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk, less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk.

METHODS: We evaluated the clinical outcomes in intermediate-risk patients with severe, symptomatic aortic stenosis in a randomized trial comparing TAVR (performed with the use of a self-expanding prosthesis) with surgical aortic-valve replacement. The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic-valve replacement. We used Bayesian analytical methods (with a margin of 0.07) to evaluate the noninferiority of TAVR as compared with surgical valve replacement.

RESULTS: A total of 1746 patients underwent randomization at 87 centers. Of these patients, 1660 underwent an attempted TAVR or surgical procedure. The mean (±SD) age of the patients was 79.8±6.2 years, and all were at intermediate risk for surgery (Society of Thoracic Surgeons Predicted Risk of Mortality, 4.5±1.6%). At 24 months, the estimated incidence of the primary end point was 12.6% in the TAVR group and 14.0% in the surgery group (95% credible interval [Bayesian analysis] for difference, -5.2 to 2.3%; posterior probability of noninferiority, >0.999). Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in lower mean gradients and larger aortic-valve areas than surgery. Structural valve deterioration at 24 months did not occur in either group.

CONCLUSIONS: TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. (Funded by Medtronic; SURTAVI ClinicalTrials.gov number, NCT01586910 .).

Original languageEnglish (US)
Pages (from-to)1321-1331
Number of pages11
JournalThe New England journal of medicine
Volume376
Issue number14
DOIs
StatePublished - Apr 6 2017

Keywords

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis
  • Bayes Theorem
  • Female
  • Heart Valve Prosthesis Implantation
  • Humans
  • Male
  • Postoperative Complications
  • Risk Factors
  • Severity of Illness Index
  • Stroke
  • Transcatheter Aortic Valve Replacement
  • Comparative Study
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

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