LABORATORY ASSESSMENT OF TARGETED ANTITHROMBOTIC THERAPIES

抗凝治疗用于各种临床适应症，包括术后血栓预防、预防房颤中的卒中和动脉血栓栓塞、治疗静脉血栓栓塞性疾病以及维持体外回路和血管通路器械的通畅性。 普通肝素（UFH）和维生素K拮抗剂华法林的给药方案已公布，实验室检查可用于监测抗凝深度。达比加群最近被FDA批准用于房颤患者，其他正在开发的抗血栓药物靶向特异性凝血因子，以提供其抗凝作用。目前，尚不清楚 这些新疗法是否在所有临床环境中，特别是在某些临床环境和特定患者人群中同样有效和安全。例如，磺达肝癸钠（fondaparinux）是Xa因子的抗凝血酶依赖性选择性抑制剂，可有效预防和治疗VTE，但已显示其不能完全阻断与导管导丝相关的血栓形成并发症。虽然实验室 在大多数临床情况下，这些新疗法的常规监测策略是不必要的，我们目前基本上没有评估任何这些化合物的抗血栓形成活性或止血效果的测试能力。随着抗凝剂替代品数量的扩大以及治疗用途的极端范围，迫切需要诊断工具来有效地评估患者是否正在接受治疗。 用这些新疗法治疗。

Anticoagulant therapy is used for a wide variety of clinical indications, including post-operative thromboprophylaxis, prevention of stroke and arterial thromboembolism in atrial fibrillation, treatment of venous thromboembolic disease, and maintaining patency of extracorporeal circuits and vascular access devices. With unfractionated heparin (UFH) and the vitamin K-antagonist warfarin, dosing regimens have been published and laboratory tests are available for monitoring the depth of anticoagulation. Dabigatran, which was recently approved by the FDA for patients with atrial fibrillation, and other antithrombotic agents in development target specific coagulation factors to provide their anticoagulant effect. Currently, it is unclear whether these new therapies will be similarly efficacious and safe In all clinical settings, particularly in certain clinical settings and specific patient populations. For example, fondaparinux, which is an antithrombin dependent selective inhibitor of factor Xa, is effective in the prevention and treatment of VTE, but it has been shown to incompletely block thrombotic complications associated with catheter guide wires. While laboratory strategies are not necessary for routine monitoring of these new therapies in most clinical situations, we currentiy have essentially no testing capability for an assessment of antithrombotic activity, or hemostatic impact, of any of these compounds. With the expanding number of anticoagulant alternatives, and the extreme range of therapeutic uses, there exists a critical need for diagnostic tools to effectively assess patients being treated with these new therapies.