Early Outcomes of a Randomized Non-Inferiority Trial Comparing TAVI Devices: The LANDMARK Trial—Coverage of EuroPCR 2024 | SCAI

Why is this study important?

  • The LANDMARK trial looks at the latest balloon expandable platform. The Myval platform was developed in India as an alternative transcatheter aortic valve implantation (TAVI or TAVR) valve. The study was done as a non-inferiority trial compared to Edwards and Medtronics TAVI systems. 
  • The developing world has an epidemic of heart disease, and alternative options may help with delivery of care and cost. The Myval is unique in that it offers more sizing increments (1.5mm), allowing the therapy to be better tailored to patients’ anatomy.

What question was this study supposed to answer? 

  • The study looked at major adverse cardiac events, as well as important valve characteristics. 384 patients were randomized to contemporary treatment with Medtronic or Edwards, or Myval. 

What did the study show?

  • Non-inferiority was reached in all of the primary endpoints. Of interest, there was much fewer post-dilations done with the Myval system (38pts) compared to 80 patients in the Edwards and Medtronic arms. It is hypothesized that the better available size options were the reason behind this finding. 
  • Continued follow-up over the next decade will be critical to determine if late failures are occurring. Overall, Myval appears to be a promising option for the global epidemic of aortic stenosis. 
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