LABORATORY ASSESSMENT OF TARGETED ANTITHROMBOTIC THERAPIES

抗凝治疗用于多种临床适应症，包括术后血栓预防、预防心房颤动时的中风和动脉血栓栓塞症、治疗静脉血栓栓塞症以及维持体外循环和血管通路设备的通畅。 对于普通肝素(UFH)和维生素K拮抗剂华法林，已经公布了给药方案，并有实验室测试可用于监测抗凝深度。达比加兰最近被FDA批准用于房颤患者，与其他抗血栓药物一起开发靶向凝血因子，为其提供抗凝作用。目前，尚不清楚 这些新疗法在所有临床环境中是否同样有效和安全，特别是在某些临床环境和特定的患者群体中。例如，磺达肝素是一种抗凝血酶依赖的Xa因子选择性抑制剂，在预防和治疗VTE方面是有效的，但已被证明不能完全阻断与导管导丝相关的血栓并发症。在实验室里 在大多数临床情况下，这些新疗法的常规监测并不需要策略，我们目前基本上没有测试能力来评估任何这些化合物的抗血栓活性或止血效果。随着抗凝剂替代品数量的增加和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的 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.