Laboratory Testing and Monitoring of Direct Oral Anticoagulants: Current State and Debate

Original abstract

Direct oral anticoagulants (DOACs) have significantly improved the care of patients requiring anticoagulation. With similar or better efficacy and safety outcomes and easier use in the outpatient setting compared with the standard-of-care vitamin K antagonists and low molecular weight heparin, DOACs are now endorsed as first-line treatment of indications including prevention of stroke and systemic embolism in nonvalvular atrial fibrillation and treatment of venous thromboembolism. DOACs are easy-to-use oral agents that offer simple dosing and short half-lives, with no need to test levels because of the wide therapeutic window and limited drug-drug interactions. After almost a decade of DOAC use, the question of testing DOAC levels in certain clinical situations has become the focus of debate. Although guidance for using routine coagulation tests is available, these tests are inadequate for optimal care. DOAC-specific tests have been developed but have limited availability in Europe and less availability in the United States. None are licensed. DOAC testing may be useful in the setting of critical clinical situations such as life-threatening bleeding or need for emergent surgery, especially with the availability of DOAC reversal agents. Patients with characteristics that fall outside the normal range may benefit from the guidance that DOAC testing could offer. Obstacles to adopting DOAC testing have been raised, such as test reliability and staffing costs; however, these problems are rapidly being resolved. Further investigation of the role of DOAC testing is needed to explore its full potential and role in clinical practice.