Design and Rationale for the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices (DOAC LVAD) Study

Abstract

Implantable left ventricular assist devices (LVAD) therapy is used to improve quality of life, alleviate symptoms, and extend survival in patients with advanced heart failure (HF). LVAD patients require chronic anticoagulation to reduce the risk of thromboembolic complications and frequently experience bleeding events. Apixaban is a direct oral anticoagulant which has become first-line therapy for patients with non-valvular atrial fibrillation and venous thromboembolism; however, its safety in LVAD patients has not been well-characterized. The evaluation of the hemocompatibility of the Direct Oral Anti-Coagulant apixaban in Left Ventricular Assist Devices (DOAC LVAD) trial is a Phase 2, open label trial of LVAD patients randomized to either apixaban or warfarin therapy. Patients randomized to apixaban will be started on a dose of 5 mg twice daily, while those randomized to warfarin will be managed to an INR goal of 2.0-2.5. All patients will be treated with aspirin 81mg daily. We plan to randomize and follow up to 40 patients for 24 weeks to evaluate the primary outcome of freedom from death or hemocompatibility related adverse events (HRAEs) (stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism). DOAC LVAD will establish the feasibility of apixaban anticoagulant therapy in LVAD patients.Clinicaltrials.gov: NCT04865978