This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device for 3 months.
Participants will have HeartMate3 LVAD implanted > 3 months before enrollment
≥ 18 years old
Treated with WARFARIN SODIUM
Participant must provide written informed consent prior to any clinical investigation related procedure
Participation in any other clinical investigation(s) involving a Mechanical Circulatory Support (MCS) device, or interventional investigation(s) likely to confound study results or affect study outcome
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
Known allergy to Apixaban
Bridge to transplant
Parallel
Warfarin
DrugWarfarin dose titrated for an International Normalized Ratio (INR) \>= 1.8
Apixaban
DrugApixaban 5 mg bid (twice a day)
Survival free of major hemocompatibility related adverse event
Major Hemocompatibility Related Adverse Event: Stroke, Pump Thrombosis, major non surgical Bleeding (moderate or severe), Arterial Peripheral Thromboembolism. Rates will be compared between study groups.
Non-surgical Major Hemorrhagic Events
Rates will be compared between study groups.
Non-surgical Major Thrombotic Events
Rates will be compared between study groups.
Survival
Rates will be compared between study groups.
Stroke Rates
Rates will be compared between study groups.
Patient functional status
Association between anticoagulant regimen and New York Heart Association (NYHA) Functional Classification (FC) will be compared between groups. Scores range I through IV, with higher scores indicating worse outcome.
Patient QOL
Kansas City Cardiomyopathy Questionnaire (KCCQ) 12 scores will be compared between groups. Scores range 1-100, with higher scores indicating better health status.
LVAD device speed
LVAD speed (mean, SD) of LVAD will be compared between study groups. Speed ranges 4500-6000 RPM.
LVAD device flow
LVAD flow (mean, SD) of LVAD will be compared between study groups. Flow ranges 3-6 L/min.
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