Objective
to compare the clinical efficacy of Myval THV (transcatheter heart valve) with contemporary THV (Sapien or Evolut) for treatment of severe aortic stenosis.
Study
prospective, multicentre non-inferiority randomised trial (margin: 10.44%)
Population
patients with severe aortic stenosis deemed eligible for TAVI
Endpoints
composite of all-cause death, all stroke, bleeding, acute kidney injury, major vascular complications, moderate severe valve regurgitation, permanent pacemaker implantation at 30 days
/medias/8784/25-T002_Baumbach_02.jpg)
/medias/8787/25-T002_Baumbach_01.jpg)
Conclusion
Myval THV is non-inferior to contemporary THV in terms of the occurrence of severe adverse events at 30 days for the treatment of severe aortic stenosis
Baumbach et al. Lancet 2024;403:2695-708