Heart failure & cardiomyopathies

Apixaban in Bridge to Transplant and Destination Left Ventricular Assist Device (LVAD) - Rationale and Study Design: The ApixiVAD Trial

ESC Heart FailPublished Randomised controlled trial

Study context

Population
Patients bridged to transplant (BTT) or for destination (DT) with HeartMate 3 LVADplanned
Participants
50 patients
Planned comparison
Apixaban as anticoagulant in HM3 LVAD patients
Primary endpoint
Death, thromboembolic events and major bleeding, including operative bleeding and immediate transplant outcomes
Follow-up
Maximum 24 months
Methodological detailsrationale and study design, pilot, multicentre, international, open-label, 1:1 randomisation, event-driven, interim analysis at 6 months, Not powered to determine non-inferiority of apixaban, Secondary outcome: quality of life related to anticoagulation, An increase in primary outcome of 20% with apixaban will be considered a signal of harm
  • Rationale and study design
  • Pilot
  • Multicentre
  • International
  • Open-label
  • 1:1 randomisation
  • Event-driven
  • Interim analysis at 6 months
  • Not powered to determine non-inferiority of apixaban
  • Secondary outcome: quality of life related to anticoagulation
  • An increase in primary outcome of 20% with apixaban will be considered a signal of harm

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Apixaban in Bridge to Transplant and Destination LVAD - Rationale and Study Design: The ApixiVAD Trial. ESC Heart Fail. Published 22 April 2024. doi:10.1002/ehf2.14782

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