Randomized Controlled Trial of Myval Transcatheter Heart Valve - LANDMARK

Jul 02, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Meril Life Sciences
Date Published:
05/22/2024
Original Posted Date:
07/02/2024
References

Contribution To Literature:

The LANDMARK trial showed that Myval is noninferior to a contemporary prosthesis during TAVR.

Description:

The goal of the trial was to evaluate transcatheter aortic valve replacement (TAVR) with the Myval prosthesis compared with a contemporary prosthesis among patients with symptomatic severe aortic stenosis. Myval is a balloon-expandable platform with prosthesis sizes that increase in diameter by 1.5 mm increments. This gives a range of prosthesis sizes of 20 mm, 21.5 mm, 23 mm, 24.5 mm, 26 mm, 27.5 mm, and 29 mm.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with severe aortic stenosis were randomized to TAVR with the Myval prosthesis (n = 384) vs. a contemporary prosthesis (Sapien or Evolut) (n = 384).

  • Total number of enrollees: 768
  • Duration of follow-up: 30 days
  • Mean patient age: 80 years
  • Percentage female: 50%
  • Percentage with diabetes: 29%

Inclusion criteria:

  • Symptomatic severe aortic stenosis
  • At least 18 years of age
  • Native aortic valve disease

Exclusion criteria:

  • Aortic annulus >29 mm

Other salient features/characteristics:

  • Bicuspid valve in 6%
  • Small aortic annulus, <4.3 cm2 in 33%

Principal Findings:

The primary outcome, all-cause mortality, stroke, major bleeding, acute kidney injury, major vascular complication, moderate or severe prosthetic valve regurgitation, or permanent pacemaker implantation was 25% with Myval vs. 27% with a contemporary valve (p for noninferiority < 0.0001, p for superiority = 0.51).

Secondary outcome:

  • Moderate or severe prosthetic valve regurgitation: 3% with Myval vs. 5% with a contemporary valve (p = 0.58)

Interpretation:

Among patients with severe aortic stenosis, TAVR with the Myval was noninferior to a contemporary prosthesis (Sapien or Evolut). All-cause mortality, stroke, major bleeding, acute kidney injury, major vascular complication, moderate or severe prosthetic valve regurgitation, or permanent pacemaker implantation was similar between treatment groups.

References:

Baumbach A, van Royen N, Amat-Santos IJ, et al. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial. Lancet 2024;403:2695-2708.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, Heart Valve Prosthesis, Transcatheter Aortic Valve Replacement


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