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

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.