论文部分内容阅读
背景:评估对中危和高危的急性冠状动脉综合征患者,在行经皮冠状动脉介入时应用直接凝血酶抑制剂比伐卢定的抗凝效果。方法:ACUITY(急性导管术和急诊介入治疗筛选策略)试验中的13819例患者被前瞻性随机分配接受肝素(普通肝素或依诺肝素)联合糖蛋白IIb/IIIa拮抗剂、比伐卢定联合糖蛋白IIb/IIIa拮抗剂或单用比伐卢定治疗。其中7789例患者是在冠状动脉造影后行经皮冠状动脉介入治疗。在该亚组中评估上述3种治疗方案对30d主要终点即联合缺血事件(死亡、心肌梗死或因心肌缺血而行计划外血运重建)、严重出血和纯临床结局(联合缺血或严重出血)的影响。采用意向治疗分析。该试验在Clinical Trials.gov的注册号为NCT00093158。
BACKGROUND: To evaluate the anticoagulant effect of bivalirudin, a direct thrombin inhibitor, for patients with moderate and high risk of acute coronary syndrome undergoing percutaneous coronary intervention. METHODS: A total of 13,819 patients in the ACUITY (acute catheterization and emergency intervention screening) trial were prospectively randomized to receive heparin (unfractionated heparin or enoxaparin) in combination with a glycoprotein IIb / IIIa antagonist, bivalirudin combined with sugar Protein IIb / IIIa antagonist or bivalirudin alone. Of these, 7,789 patients underwent percutaneous coronary intervention after coronary angiography. In the subgroup, the three treatment regimens were evaluated for major 30-day outcomes of the combined ischemic events (death, myocardial infarction, or unplanned revascularization due to myocardial ischemia), severe bleeding, and pure clinical outcome (combined with ischemia or Severe bleeding). Adopt intention therapy analysis. The trial is registered with Clinical Trials.gov as NCT00093158.