Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.
There is an unmet clinical need for an alternative to warfarin, such as a direct oral anticoagulant (DOAC), as anticoagulation in participants with an aortic mechanical prosthetic valve. Some participants may be genetically hyper- or hypo-responsive to warfarin, which makes management difficult. Another small group of participants is allergic to warfarin. A much larger group of participants has difficulty maintaining warfarin control due to dietary and drug interactions. Finally, the requirement for routine blood testing makes people reluctant to take warfarin. All of these factors drive younger participants in need of aortic valve replacement (AVR) toward selection of a tissue valve instead of a mechanical valve. Despite multiple studies (randomized, matched and risk adjusted) that show that tissue valves are associated with worse outcomes, younger participants choose this type of valve to avoid warfarin. In addition, multiple clinical studies have shown valve reoperation rates are higher for tissue valves used in these younger participants. Providing an alternative to warfarin anticoagulation may lead younger participants to choose a mechanical valve with greater durability and better clinical outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
863
For patients that do NOT meet the following criteria * age ≥ 80 years * weight ≤ 60 kilograms * creatinine ≥ 1.5 mg/dL (133 micromol/L)
For patients that meet at least 2 of the following criteria * age ≥ 80 years * weight ≤ 60 kilograms * creatinine ≥ 1.5 mg/dL (133 micromol/L)
Active Control Intervention
Composite of Valve Thrombosis and Valve-related Thromboembolism
Valve thrombosis was defined as any thrombus, not caused by infection, attached to or near an implanted On-X valve that occluded part of the blood-flow path, interfered with valve function, or was sufficiently large to warrant treatment other than continued oral anticoagulation. Valve-related thromboembolism was defined as any thromboembolic stroke, transient ischemic attack, myocardial infarction, or arterial thromboembolism to an organ or limb that was not associated with infection or an intracardiac tumor and was definitely or possibly related to the valve.
Time frame: through study closure, a median follow-up of 13.5 months
Major Bleeding
Major bleeding defined as any episode of internal or external bleeding that caused death, hospitalization, or permanent injury or necessitated transfusion, pericardiocentesis, or reoperation.
Time frame: through study closure, a median follow-up of 13.5 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
Tucson Heart Center
Tucson, Arizona, United States
CHI St. Vincent Heart Institute
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Sharp Memorial
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale- New Haven Hospital
New Haven, Connecticut, United States
Baycare Health / Morton Plant Hospital
Clearwater, Florida, United States
Shands Hospital (University of Florida Health)
Gainesville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
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