Biomarkers in the monitoring of anticoagulant therapies: Clinical applications, diagnostic efficacy, and challenges for the clinical laboratory. Literature review

The implementation of coagulation assays enables precise evaluation of the hemostatic status of patients, which is essential for the prevention of thrombotic events such as deep vein thrombosis, pulmonary embolism, cerebrovascular accidents, and acute myocardial infarction. We conducted a literature review following the PRISMA guidelines, encompassing 78 articles published between 2019 and 2025 that focused on biomarkers for monitoring anticoagulant therapy. Of these, 38 studies met eligibility criteria by providing data on sensitivity, specificity, advantages and limitations of the biomarkers in anticoagulants patients. Results demonstrated that traditional biomarkers, including platelet count, prothrombin time, international normalized ratio, activated partial thromboplastin time, D dimer, are useful for evaluating coagulation activation but have notable limitations in patients treated with direct anticoagulants. In contrast, advanced assays, such as thrombin generation assays, allow comprehensive analysis of the entire thrombin generation process, offering a more complete assessment of the hemostatic system. The combined use of conventional biomarkers and global assays holds significant potential to markedly improve anticoagulant therapy monitoring by facilitating safe individualization of treatment and minimizing both thrombotic and hemorrhagic risk.