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普拉格雷或双倍剂量氯吡格雷用于克服氯吡格雷低反应性——TAILOR(经皮冠状动脉介入治疗中血小板与口服抗血小板治疗个体化)随机试验

Prasugrel or double-dose clopidogrel to overcome clopidogrel low-response--the TAILOR (Thrombocytes And IndividuaLization of ORal antiplatelet therapy in percutaneous coronary intervention) randomized trial.

作者信息

Dridi Nadia Paarup, Johansson Pär Ingemar, Clemmensen Peter, Stissing Trine, Radu Maria Dumitrela, Qayyum Abbas, Pedersen Frants, Helqvist Steffen, Saunamäki Kari, Kelbæk Henning, Jørgensen Erik, Engstrøm Thomas, Holmvang Lene

机构信息

Department of Cardiology, University of Copenhagen , Rigshospitalet , Denmark and.

出版信息

Platelets. 2014;25(7):506-12. doi: 10.3109/09537104.2013.845874. Epub 2013 Nov 18.

Abstract

High on-treatment platelet reactivity (HTPR) is associated with poor prognosis in patients undergoing percutaneous coronary intervention (PCI). The antiplatelet effect and safety of prasugrel was compared to that of double-dose clopidogrel in patients with stable coronary artery disease or acute coronary syndrome (ACS) exhibiting HTPR on clopidogrel and treated with PCI, using multiple electrode aggregometry (MEA) to assess platelet reactivity. Of 923 patients screened, 237 (25.7%) exhibited HTPR. Of these, 106 were eligible for participation in a randomized trial comparing two intensified antiplatelet regimen: 52 were assigned to double maintenance-dose clopidogrel and 54 to standard-dose prasugrel. At 1 month, tailoring antiplatelet therapy improved platelet inhibition to a level considered as therapeutic in 73.1% of patients. Prasugrel entailed greater platelet inhibition (p = 0.02) and a lower rate of persisting HTPR at follow-up compared to double-dose clopidogrel (HTPR persisted in 20.4% and 42% respectively, p = 0.02). Within the 30-day follow-up, no major bleeds were observed and the incidence of major adverse cardiovascular events (MACE) was similar in the two treatment arms. Prasugrel demonstrated superiority to double-dose clopidogrel in overcoming HTPR and reducing platelet activity. Intensifying antiplatelet therapy in both ACS and stable angina pectoris (SAP) patients exhibiting HTPR prior to PCI was well tolerated.

摘要

经皮冠状动脉介入治疗(PCI)患者的高治疗期血小板反应性(HTPR)与预后不良相关。在接受PCI治疗且对氯吡格雷表现出HTPR的稳定冠状动脉疾病或急性冠状动脉综合征(ACS)患者中,使用多电极聚集测定法(MEA)评估血小板反应性,比较了普拉格雷与双倍剂量氯吡格雷的抗血小板作用和安全性。在923例筛查患者中,237例(25.7%)表现出HTPR。其中,106例符合参与比较两种强化抗血小板方案的随机试验条件:52例被分配至双倍维持剂量氯吡格雷组,54例被分配至标准剂量普拉格雷组。在1个月时,调整抗血小板治疗使73.1%的患者血小板抑制改善至被认为具有治疗作用的水平。与双倍剂量氯吡格雷相比,普拉格雷在随访时具有更强的血小板抑制作用(p = 0.02)且持续存在HTPR的发生率更低(分别为20.4%和42%,p = 0.02)。在30天随访期内,未观察到严重出血事件,两个治疗组的主要不良心血管事件(MACE)发生率相似。在克服HTPR和降低血小板活性方面,普拉格雷显示出优于双倍剂量氯吡格雷的效果。在PCI术前表现出HTPR的ACS和稳定型心绞痛(SAP)患者中强化抗血小板治疗耐受性良好。

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