093643_抗凝治疗新时代课件.ppt

* * * * * * 两组基线特征一致 * * * * 初步数据(来源: 11899 study report; table 20, page 120) 我们可以看到，利伐沙班组的事件发生率显著低于对照组。 * 利伐沙班组累积事件发生率显著低于安慰剂组，使VTE复发的相对风险下降82％ * * 在主要疗效终点的亚组分析中，在绝大多数亚组中均显示利伐沙班疗效显著优于对照组。 * * * 大出血事件发生率，利伐沙班组为0.7％，安慰剂组为0，未达到显著性差异。在利伐沙班组的4例大出血中，未有1例导致死亡或重要器官出血。3例为胃肠道出血，1例为月经过多。 * * 初步数据(来源: 11899 study report; table 38, pages 191–192) 临床相关的非大出血事件的发生率，安慰剂组为1.2％，利伐沙班组为5.4％，达到统计学显著性差异。但利伐沙班组的临床相关的非大出血事件集中在泌尿生殖系出血，鼻出血，直肠/肛门出血和皮肤出血，主要为粘膜出血，大多数患者（81%）恢复或继续了研究药物的治疗。 * * 初步数据(来源: 11899 study report; table 27, page 142和拜耳生物统计学提供) ITT population：意向治疗分析人群 在其他终点分析上，两组发生率相当。 * * 无利伐沙班导致的肝脏损伤的证据。 * * The Framingham Heart Study evaluated the impact of the presence or absence of coronary heart disease, hypertension, heart failure, and non-rheumatic AF on the incidence of stroke This analysis demonstrated that the presence of coronary heart disease more than doubled the risk of stroke (risk ratio 2.4), the presence of hypertension more than tripled the risk of stroke (risk ratio 3.4) and heart failure more than quadrupled the risk of stroke (risk ratio 4.3). However, of all these factors, AF was the most important independent risk factor for stroke, increasing stroke risk almost 5-fold (risk ratio 4.8) AF is associated with a risk of thrombus formation in the left atrium. Such thrombi can embolize to the brain, resulting in an ischemic stroke. The pathogenesis of intra-cardiac thrombus formation in patients with AF is multifactorial and relates to the fulfilment of Virchow’s classic triad (stasis of blood in fibrillating atria, atrial endocardial damage and abnormal changes in blood constituents), which together perpetuate a hypercoaguable state Abbreviation AF, atrial fibrillation References Wolf et al. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983–988. Watson et al. Mechanisms of thrombogenesis in atrial fibrillation: Virchow’s triad revisited. Lancet 2009;373:155–166. Prevalence of AF Over the past decade, several st