Ahuja Tania, Raco Veronica, Bhardwaj Sharonlin, Green David
NYU Lanogne Health, Department of Pharmacy, 550 First Avenue, New York, New York, 10016, USA.
New York University Grossman School of Medicine, Department of Medicine, 550 First Avenue, New York 10016, USA.
Adv Hematol. 2023 Feb 22;2023:9511499. doi: 10.1155/2023/9511499. eCollection 2023.
The need for therapeutic drug monitoring of direct oral anticoagulants (DOACs) remains an area of clinical equipoise. Although routine monitoring may be unnecessary given predictable pharmacokinetics in most patients, there may be altered pharmacokinetics in those with end organ dysfunction, such as those with renal impairment, or with concomitant interacting medications, at extremes of body weight or age, or in those with thromboembolic events in atypical locations. We aimed to assess real-world practices in situations in which DOAC drug-level monitoring was used at a large academic medical center. A retrospective review of the records of patients who had a DOAC drug-specific activity level checked from 2016 to 2019 was included. A total of 119 patients had 144 DOAC measurements (apixaban ( = 62) and rivaroxaban ( = 57)). Drug-specific calibrated DOAC levels were within an expected therapeutic range for 110 levels(76%), with 21 levels (15%) above the expected range and 13 levels (9%) below the expected range. The DOAC levels were checked in the setting of an urgent or emergent procedure in 28 patients (24%), followed by renal failure in 17 patients (14%), a bleeding event in 11 patients (9%), concern for recurrent thromboembolism in 10 patients (8%), thrombophilia in 9 patients (8%), a history of recurrent thromboembolism in 6 patients (5%), extremes of body weight in 7 patients (5%), and unknown reasons in 7 patients (5%). Clinical decision making was infrequently affected by the DOAC monitoring. Therapeutic drug monitoring with DOACs may help predict bleeding events in elderly patients, those with impaired renal function, and in the event of an emergent or urgent procedure. Future studies are needed to target the select patient-specific scenarios where monitoring DOAC levels may impact clinical outcomes.
直接口服抗凝剂（DOACs）的治疗药物监测需求仍是临床权衡的一个领域。尽管鉴于大多数患者可预测的药代动力学，常规监测可能不必要，但在终末器官功能障碍患者中，如肾功能损害患者，或在体重或年龄极端情况下、或有非典型部位血栓栓塞事件的患者中，药代动力学可能会改变，或同时使用相互作用的药物时，药代动力学也可能改变。我们旨在评估在一家大型学术医疗中心使用DOAC药物水平监测的实际情况。纳入了对2016年至2019年期间进行DOAC药物特异性活性水平检查的患者记录的回顾性研究。共有119名患者进行了144次DOAC测量（阿哌沙班（n = 62）和利伐沙班（n = 57））。110次测量（76%）的药物特异性校准DOAC水平在预期治疗范围内，21次测量（15%）高于预期范围，13次测量（9%）低于预期范围。28名患者（24%）在紧急或急诊手术情况下进行了DOAC水平检查，其次是17名肾功能衰竭患者（14%）、11名出血事件患者（9%）、10名复发性血栓栓塞患者（8%）、9名血栓形成倾向患者（8%）、6名复发性血栓栓塞病史患者（5%）、7名体重极端患者（5%）以及7名原因不明患者（5%）。临床决策很少受到DOAC监测的影响。DOACs的治疗药物监测可能有助于预测老年患者、肾功能受损患者以及紧急或急诊手术情况下的出血事件。未来需要针对特定患者的特定情况进行研究，在这些情况下监测DOAC水平可能会影响临床结局。
