摘要
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: The aim of this study was to assess anticoagulation with the direct thrombin inhibitor bivalirudin during percutaneous coronary intervention in individuals with moderate and high-risk acute coronary syndromes. Methods: 13 819 individuals in the Acute Catheterization and Urgent Intervention Triage strategy(ACUITY) trial were prospectively randomly assigned to receive heparin(unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibitors, bivalirudin plus glycoprotein IIb/IIIa inhibitors, or bivalirudin alone. Of these individuals, 7789 underwent percutaneous coronary intervention after angiography. The effect of the three regimens on the primary 30-day endpoints of composite ischaemia(death, myocardial infarction, or unplanned revascularisation for ischaemia), major bleeding, and net clinical outcomes(composite ischaemia or major bleeding) was assessed in this subgroup. Analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, with the number NCT00093158. Findings: Of the individuals who underwent percutaneous coronary intervention, 2561 received heparin plus glycoprotein IIb/IIIa inhibitors, 2609 received bivalirudin plus glycoprotein IIb/IIIa inhibitors, and 2619 received bivalirudin alone. 26(0.3% ) individuals dropped out or were lost to follow-up. There was no significant difference in the proportion of individuals with composite ischaemia, major bleeding, or net clinical outcomes at 30 days between those who received bivalirudin plus glycoprotein IIb/IIIa inhibitors and those who received heparin plus glycoprotein IIb/IIIa inhibitors(composite ischaemia: 243[9% ] patients vs 210[8% ]patients, p=0.16; major bleeding: 196[8% ] patients vs 174[7% ] patients, p=0.32; net clinical outcomes: 389[15% ] patients vs 341[13% ] patients, p=0.1). Rates of composite ischaemia were much the same in those who received bivalirudin alone and those who received heparin plus glycoprotein IIb/IIIa inhibitors(230[9% ] patients vs 210[8% ] patients, p=0.45); however, there were significantly fewer individuals who experienced major bleeding among those who received bivalirudin alone than among those who received heparin plus glycoprotein IIb/IIIa inhibitors(92[4% ] patients vs 174[7% ] patients, p< 0.0001, relative risk 0.52, 95% CI 0.40- 0.66), resulting in a trend towards better 30-day net clinical outcomes(303[12% ]patients vs 341[13% ] patients, p=0.057; 0.87, 0.75- 1.00). Interpretation: Substitution of unfractionated heparin or enoxaparin with bivalirudin results in comparable clinical outcomes in patients with moderate and high-risk acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors in whom percutaneous coronary intervention is done. Anticoagulation with bivalirudin alone suppresses adverse ischaemic events to a similar extent as does heparin plus glycoprotein IIb/IIIa inhibitors, while significantly lowering the risk of major haemorrhagic complications.
