Laboratory of Haematology and Blood Bank Unit, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Platelets. 2012;23(6):481-9. doi: 10.3109/09537104.2012.689037. Epub 2012 May 30.
Light transmittance aggregometry (LTA) has been extensively used in monitoring clopidogrel therapy. However, the availability of simple and rapid point-of-care platelet function assays is of great clinical importance. Thus, the manufacturer of the Platelet Function Analyzer (PFA)-100 System has recently produced the INNOVANCE PFA P2Y test cartridge. We assessed the ability of this new test to reliably detect clopidogrel resistance. We enrolled 90 consecutive patients with coronary artery disease receiving chronic clopidogrel maintenance therapy in combination with aspirin. Twenty healthy volunteers served as controls. Clopidogrel resistance was simultaneously analysed by the INNOVANCE PFA P2Y test cartridge, ADP-induced LTA, the flow-cytometric vasodilator-stimulated phosphoprotein (VASP)-phosphorylation assay and the multiple electrode aggregometry (Multiplate). Agreement among the four platelet function methods by two was assessed using Cohen's kappa coefficient. According to the cut-off points for clopidogrel resistance proposed by the literature, agreement was fair between INNOVANCE PFA-100 P2Y and LTA (74.4%) and Multiplate (75.6%), while poor agreement was noticed in VASP assay (63.3%). Based on cut-off points indicating a higher thrombotic risk, agreement between the PFA-100 System and the other three methods did not significantly differ compared to the previous cut-offs (72.2%, 71.1% and 55.1%, respectively). The INNOVANCE PFA-100 P2Y test seems to be comparable to other established platelet function assays in detecting clopidogrel resistance. However, the modest agreement among platelet function methods makes the performance of platelet function testing crucial with more than one technique in order to reliably identify poor responders to clopidogrel treatment.
光透射聚集法(LTA)已广泛用于监测氯吡格雷治疗。然而,简单、快速的即时血小板功能检测方法具有重要的临床意义。因此,血小板功能分析仪(PFA)-100 系统的制造商最近生产了 INNOVANCE PFA P2Y 检测试剂盒。我们评估了该新检测方法可靠检测氯吡格雷抵抗的能力。我们纳入了 90 例连续接受氯吡格雷维持治疗联合阿司匹林治疗的冠心病患者。20 名健康志愿者作为对照组。同时使用 INNOVANCE PFA P2Y 检测试剂盒、ADP 诱导的 LTA、流式细胞术血管扩张刺激磷蛋白(VASP)磷酸化检测和多电极聚集法(Multiplate)分析氯吡格雷抵抗。使用 Cohen's kappa 系数评估两种方法之间四种血小板功能方法的一致性。根据文献提出的氯吡格雷抵抗的截止值,INNOVANCE PFA-100 P2Y 和 LTA(74.4%)和 Multiplate(75.6%)之间的一致性为中等,而 VASP 检测(63.3%)的一致性较差。基于提示更高血栓风险的截止值,与之前的截止值相比,PFA-100 系统与其他三种方法之间的一致性没有显著差异(分别为 72.2%、71.1%和 55.1%)。INNOVANCE PFA-100 P2Y 检测似乎与其他已建立的血小板功能检测方法在检测氯吡格雷抵抗方面相当。然而,血小板功能检测方法之间的一致性较差,为了可靠识别氯吡格雷治疗反应不佳的患者,需要使用多种技术进行血小板功能检测。