比伐芦定在高出血风险患者介入治疗中抗凝疗效和安全性评价

Efficacy and safety of Bivalirudin on high-risk hemorrhage patients undergoing percutaneous coronary intervention

目的 评价比伐芦定在高出血风险急性冠脉综合征（ACS）患者介入治疗中的抗凝疗效和安全性.方法 随机将入选的ACS患者分为比伐芦定组（104例）和肝素组（102例）,PCI术中分别采用比伐芦定和普通肝素进行抗凝治疗,并根据术中冠脉病变情况决定是否联用血小板糖蛋白Ⅱb/Ⅲa拮抗剂（GPI）.比较两组间一般情况及PCI相关资料,并对两组30 d内的出血、 支架血栓事件及主要不良心血管事件（MACE）进行统计分析.结果 研究中所有PCI手术患者30 d内均未发生支架内血栓事件;两组间MACE发生率（11.5%比9.8%,P〉0.05）未见统计学差异.比伐芦定组出血发生率显著降低（7.7%比12.7%,P〈0.05）,其中以轻度出血发生率减少更为显著（5.8%比9.8%,P〈0.05）,严重出血方面两组间未见统计学差异（1.9%比2.9%,P〉0.05）,但比伐芦定组严重出血风险趋势较低.结论 比伐芦定在高出血风险ACS患者的PCI治疗中抗凝治疗是安全有效的,并降低出血风险.

Objective To evaluate the efficacy and safety of Bivalirudin on high-risk hemorrhage patients with acute coronary syndrome（ACS） during percutaneous coronary intervention. Methods A total of 206 ACS pa-tients were randomly assigned to receive Bivalirudin （n=104） or unfractionated heparin （UFH）（n=102） with or without glycoprotein Ⅱb/Ⅲa inhibitor （GPI） during PCI. The baseline condition, data related PCI and bleeding, stent thrombosis events, and MACEs in 30 days between the two groups were compared. Results In this study, all the patients undergoing PCI hadn′t occurred stent thrombosis events in 30 days, and no significant difference was observed in the incidence of MACEs （11.5% vs 9.8%, P〉0.05） between the two groups. Bivalirudin signifi-cantly reduced the incidence of bleeding（7.7% vs 12.7%, P〈0.05）, mainly in mild bleeding（5.8% vs 9.8%, P〈0.05）, except the severe bleeding（1.9% vs 2.9%, P〉0.05）. Conclusion Compared with UFH, the application of Bivalirudin was safe and effective during PCI in patients with ACS at high risk of bleeding, and was associated with a lower incidence of bleeding.