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

• Published in: Journal of cardiac failure Vol. 30; no. 6; pp. 819 - 828
• Main Authors: Dimond, Matthew, Looby, Mary, Shah, Bhruga, Sinha, Shashank S., Isseh, Iyad, Rollins, Allman T., Abdul-Aziz, Ahmad A., Kennedy, Jamie, Tang, Daniel G., Klein, Katherine M., Casselman, Samantha, Vermeulen, Christen, Sheaffer, Wendy, Snipes, Meredith, O'connor, Christopher M., Shah, Palak
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2024
• Subjects: Administration, Oral; anticoagulants; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; Anticoagulants - therapeutic use; apixaban; factor Xa inhibitors; Factor Xa Inhibitors - administration & dosage; Factor Xa Inhibitors - therapeutic use; Female; Heart Failure - therapy; Heart-Assist Devices; Humans; Male; Middle Aged; Pyrazoles - administration & dosage; Pyrazoles - therapeutic use; Pyridones - administration & dosage; Pyridones - therapeutic use; Ventricular assist device; warfarin; Warfarin - administration & dosage; Warfarin - therapeutic use; GIB; FDA; DSMB; INR; apixaban; DOAC; LVAD; warfarin; HM3; HRAE; anticoagulants; IFU; factor Xa inhibitors; Ventricular assist device
• ISSN: 1071-9164; 1532-8414; 1532-8414
• DOI: 10.1016/j.cardfail.2023.10.473

Implantable left ventricular assist device (LVAD) therapy is used to improve quality of life, alleviate symptoms and extend survival rates in patients with advanced heart failure. Patients with LVADs require chronic anticoagulation to reduce the risk of thromboembolic complications, and they commonly experience bleeding events. Apixaban is a direct oral anticoagulant that has become first-line therapy for patients with nonvalvular atrial fibrillation and venous thromboembolism; however, its safety in patients with LVADs has not been well characterized. The evaluation of the hemocompatibility in the DOAC LVAD (Direct Oral Anti-Coagulant apixaban in Left Ventricular Assist Devices) trial is a phase 2, open-label trial of patients with LVADs who were randomized to either apixaban or warfarin therapy. Patients randomized to apixaban will be started on a dosage of 5 mg twice daily, whereas those randomized to warfarin will be managed at an International Normalized Ratio goal of 2.0–2.5. All patients will be treated with aspirin at 81 mg daily. We plan to randomize and follow as many as 40 patients for 24 weeks to evaluate the primary outcomes of freedom from death or hemocompatibility-related adverse events (stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism). The DOAC LVAD trial will establish the feasibility of apixaban anticoagulant therapy in patients with LVADs. Clinicaltrials.gov: NCT04865978 Visual graphic: DOAC LVAD study design schematic. As many as 40 patients implanted with an LVAD will be enrolled and randomized in a 1:1 ratio to anticoagulation with either 5 mg apixaban or warfarin titrated to an INR goal of 2.0–2.5. Enrollment will be stratified by either < 3 months or ≥ 3 months from LVAD implant, and enrollment of patients ≥ 3 months from implant will be capped at 20 participants. [Display omitted]