SMART Trial: TAVR in Small Aortic Annulus

smart trial tavr

Year: 2024 Title: SMART TRIAL Subtitle: Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus Type of Trial: A prospective, randomized controlled, post-market trial

Objective: To generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.

Patients: 716

Inclusion Criteria:

  • Age ≥18 years
  • Symptomatic severe aortic stenosis
  • Aortic-valve annulus area of 430 mm2 or less
  • Operative mortality risk <15%


  • TAVR with SE Valve (n = 355)
  • TAVR with a BE valve (n = 361)

Primary Outcomes:

  1. Composite of death, disabling stroke, or rehospitalization for HF through 12 months (%)
    • SE Valve: 9.4%
    • BE Valve: 10.6%
    • P<0.001 for noninferiority
  2. Bioprosthetic-valve dysfunction through 12 months (%)
    • SE Valve: 9.4%
    • BE Valve: 41.6%
    • P<0.001 for superiority

Secondary Outcomes:

  1. The aortic-valve mean gradient at 12 months (mmHg)
    • SE Valve: 7.7
    • BE Valve: 15.7
    • P < 0.001
  2. Patients with moderate or severe prosthesis–patient mismatch at 30 days (%)
    • SE Valve: 11.2%
    • BE Valve: 35.3%
    • P < 0.001

Conclusion: Among patients with severe aortic stenosis and a small aortic annulus who underwent TAVR, a self-expanding supraannular valve was noninferior to a balloon-expandable valve with respect to clinical outcomes and was superior with respect to bioprosthetic-valve dysfunction through 12 months.

Reference: Herrmann HC et al. N Engl J Med 2024; DOI: 10.1056/NEJMoa2312573

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