ST抬高急性心肌梗死治疗指南知识讲稿.ppt

* * * 比伐卢定：有抗因子II活性的抗凝剂，为直接凝血酶抑制剂 * 比伐卢定：有抗因子II活性的抗凝剂，为直接凝血酶抑制剂 * OASIS-6研究发现，PCI亚组中接受Fondaparinux的STEMI患者30天的死亡率和再梗死发生率增加1%。 * * * 普拉格雷比氯吡格雷的抗血小板作用更强。 Patients were candidates for the trial if they were moderate-high risk, had an acute coronary syndrome, and there was a plan to perform PCI.  A sample size of 13, 600 was considered necessary to provide at least 90 % power to test the primary hypothesis All patients were to receive ASA. Randomization was stratified by UA/NSTEMI vs STEMI DB study drug therapy consisted either of - standard dosing with clopidogrel with a LD of 300 mg and MD of 75 mg - OR prasugrel with a LD of 60 mg and MD of 10 mg DB study drug was to be given for a median of at least 12 months with a minimum of 6 mos and maximum of 15 months The primary composite EP was CV death, MI, or Stroke through the end of the study Key secondary EPs are listed here and among these was Stent thrombosisKey safety Eps included: TIMI major (non CABG) bleeds, and life-threatening bleeds Two key substudies are evaluating pharmacokinetics and genomics * * * 在主要终点事件方面从第3天两组就开始有明显差异，并持续整个随访期。 This slide depicts the balance of efficacy and safety observed in the trial. At the top is shown the significant reduction in the primary endpoint as presented a few moments ago. The number needed to treat to prevent one event was 46 At the bottom is the rate of TIMI major non CABG bleeds--a key safety endpoint-- which was 2.4% with prasugrel and 1.8% with clopidogrel—a 0.6% Absolute risk increase. The excess of 35 major bleeds with prasugrel corresponded to an HR of 1.32 and P value of 0.03 . The number of subjects who would need to be treated to result in one excess major bleed (NNH) was 167. * * * The beneficial effect of prasugrel on the primary end point was consistent across key prespecified major subgroups. Notable observations include: A significant benefit in both the UA/NSTEMI and STEMI cohorts There was a consistent reduction in events with prasugrel in m