Two-year outcomes in the direct oral anticoagulant apixaban in left ventricular assist devices (DOAC LVAD) study

Aditya Mehta, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Pramita Bagchi, Department of Biostatistics and Bioinformatics, George Washington University, Washington, District of Columbia.
Mary Looby, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Matthew Dimond, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Iyad Isseh, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Allman Rollins, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Ahmad Abdul-Aziz, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Jamie L. Kennedy, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Daniel Tang, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Wendy Sheaffer, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Meredith Snipes, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Bhruga Shah, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Shashank Sinha, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Christopher M. O'Connor, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia.
Palak Shah, Heart Failure, Mechanical Circulatory Support and Transplant, Inova Schar Heart and Vascular, Falls Church, Virginia. Electronic address: Palak.shah@inova.org.

Document Type

Journal Article

Publication Date

8-15-2025

Journal

The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation

DOI

10.1016/j.healun.2025.08.012

Keywords

apixaban; direct-acting oral anticoagulants; factor Xa inhibitors; ventricular assist device; warfarin

Abstract

Anticoagulation with apixaban was previously demonstrated to be feasible without excess hemocompatibility-related adverse events (HRAEs) at 6 months but longer-term data on use of apixaban is lacking. We report 2-year outcomes of patients enrolled into the DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) study. The primary study outcome was death or major HRAE (stroke, device thrombosis, major bleeding, aortic root thrombus, and/or arterial non-central nervous system thromboembolism). Patients were randomized to treatment with apixaban (5 mg twice daily, without dose adjustment) as compared to warfarin (INR goal of 2.0 to 2.5). A total of 30 patients were randomized (16 to apixaban, 14 to warfarin). At 2-years, the primary outcome occurred in 2 patients (12.5%) in the apixaban group compared to 6 patients (43%) in the warfarin group (p = 0.087). In the apixaban group, HRAEs occurred in 1 patient (6.3%, major bleeding), compared to 5 HRAEs with warfarin (35.7%, 1 hemorrhagic stroke, 3 major bleeds, and 1 right ventricular thrombus formation, p = 0.07). All bleeding episodes were gastrointestinal. These findings support the long-term feasibility of apixaban anticoagulation in patients with a LVAD and underscore the need for larger randomized trials to confirm these findings.

Department

Biostatistics and Bioinformatics

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