Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices

作者：Palak Mayur Shah, Mary Looby, Matthew G. Dimond, Pramita Bagchi, Bhruga Shah, Iyad N. Isseh, Allman T. Rollins, Ahmad A. Abdul-Aziz, Jamie L.W. Kennedy, Daniel G. Tang, Katherine M. Klein, Samantha Casselman, Christen Vermeulen, Wendy Sheaffer, M. Burton Snipes, Shashank S. Sinha, Christopher M. O’Connor · 发表于：JACC Heart Failure · 年份：2024 · DOI：10.1016/j.jchf.2024.04.013 · 被引用次数：50 · 研究领域：Mechanical Circulatory Support Devices、Cardiac Arrest and Resuscitation、Respiratory Support and Mechanisms

BACKGROUND: Patients receiving left ventricular assist device (LVAD) support require long-term anticoagulation to reduce the risk of thromboembolic complications. Apixaban is a direct oral anticoagulant that has become first-line therapy; however, its safety in LVAD recipients has not been well described. OBJECTIVES: This study sought to investigate whether, in patients with a fully magnetically levitated LVAD, treatment with apixaban would be feasible and comparable with respect to safety and freedom from the primary composite outcome of death or major hemocompatibility-related adverse events (HRAEs) (stroke, device thrombosis, major bleeding, aortic root thrombus, and arterial non-central nervous system thromboembolism) as compared with treatment with warfarin. METHODS: The DOAC LVAD (Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices) trial was a phase 2, open label trial of LVAD recipients randomized 1:1 to either apixaban 5 mg twice daily or warfarin therapy. All patients were required to take low-dose aspirin. Patients were followed up for 24 weeks to evaluate the primary composite outcome. RESULTS: A total of 30 patients were randomized: 14 patients to warfarin and 16 patients to apixaban. The median patient age was 60 years (Q1-Q3: 52-71 years), and 47% were Black patients. The median time from LVAD implantation to randomization was 115 days (Q1-Q3: 56-859 days). At 24 weeks, the primary composite outcome ...