抗凝药物发展简史-新一代抗凝药安卓幻灯片.ppt

* 安卓组3.9%患者出现有症状的复发性VTE事件，而依诺肝素组为4.1%，绝对差异为0.15%（95%CI：-1.8至1.5），有利于安卓。可信区间的上限低于事先确定的3.5的非劣效性标准，证明安卓不比依诺肝素差。在符合方案人群分析（在非劣效性试验中也是建议的）中，差异为0.9%，说明安卓比较好（95%CI：-2.6至0.8）。 在意向治疗人群中（图9），安卓组3.8%患者出现有症状的复发性血栓栓塞事件，而UFH组为5.0%，绝对差异为1.2%（95%CI：-3.0至0.5）有利于安卓，对应的相对危险性降低25%。可信区间的上限（0.5）低于事先确定的3.5的非劣效性标准，证明安卓不比UFH差。在符合方案人群分析（在非劣效性试验中也是建议的）中，差异为1.5%，有利于安卓（95%CI：-3.3至0.3）。 * * * * 原因？ * Forty-four of the excess 64 deaths observed at study end with enoxaparin relative to fondaparinux, were accounted for by patients who died after having experienced a major bleed （79 enoxaparin vs. 38 fondaparinux）, and 20 by patients who died after having experienced a minor bleed （33 enoxaparin vs. 13 fondaparinux）. Therefore, almost the entire difference in the number of deaths recorded at study end could be attributed to the lower bleeding rates with fondaparinux. * In the ISAR-REACT study, patients (N=2,159, mean age 66 years) received 600 mg clopidogrel at least 2 hours before a PCI procedure with aspirin and a heparin bolus of 70 U/kg. They were then randomized to either abciximab (bolus 0.25 mg/kg, infusion 0.125 mg/kg/min for 12 hours) or a placebo infusion. Thereafter, all patients received clopidogrel 75 mg twice daily until discharge and then 75 mg clopidogrel daily for at least 4 weeks along with aspirin (?100 mg/d). All patients had symptomatic coronary artery disease, but patients with acute coronary syndromes and other patients considered to be at high risk were excluded.* *High-risk exclusion criteria: acute coronary syndromes; acute myocardial infarction within 14 days, ST-segment depression, positive biomarkers, insulin-dependent diabetes, chronic total occlusions, ejection fraction ? 30%, thrombus and lesions in bypass grafts. Sch?mig A, Mehilli J, Dotzer F, et al. ISAR-REACT: glycoprotein IIb/IIIa inhibition with abciximab in patients undergoing coronary stenting after pretreatment with a high loading dose of clopidogrel: a multicenter, randomized, double blind, placebo-con