比伐卢定在肾功能不全ACS患者PCI中的疗效及安全性研究

Efficacy and safety of bivalirudin in patients with acute coronary syndrome and renal dysfunction post PCI

目的:探讨合并肾功能不全的急性冠状动脉综合征(ACS)患者经皮冠状动脉介入治疗(PCI)围手术期应用比伐卢定的安全性和有效性。方法:215例拟行PCI术的肾功能不全ACS患者被随机分为比伐卢定组109例和肝素组106例,分别于术中应用比伐卢定和肝素抗凝,比较两组患者术中抗凝效果,术后30d内出血事件及主要心血管不良事件(MACE)发生率。结果:比伐卢定组和肝素组术中活化凝血酶时间(ACT)及其达标率比较差异均无统计学意义(P>0.05),两组患者术后30d内MACE事件发生率差异无统计学意义(P>0.05),比伐卢定组术后30d内轻度出血及总体出血发生率显著低于肝素组(P<0.05),且不随肾功能下降而显著增加出血风险。结论:比伐卢定在伴有肾功能不全的ACS患者PCI术中的抗凝效果与肝素相当,且能明显减少术后出血发生率。

Objective：To explore the safety and efficacy of bivalirudin during perioperation of percutaneous coronary intervention（PCI）in acute coronary syndrome（ACS）patients with renal dysfunction.Method：The 215 ACS patients with renal dysfunction who received PCI were randomly divided into two groups,bivalirudin group（109 cases）and heparin group（106 cases）.The anticoagulant effect,incidence of bleeding events and major adverse cardiac events（MACE）within 30 days post operation were compared between the two groups.Result：The difference of the activated coagulation time（ACT）and its success rate between two groups have no statistical significance（P0.05）,and the same as it was in the MACE in 30 dafter PCI between two groups（P0.05）.Compared with heparin group,patients in bivalirudin group had lower levels of incidence of mild hemorrhage and overall incidence of bleeding in 30 dafter PCI（P0.05）,and there was no significant increasing incidence of bleeding along with the decline of renal function.Conclusion：Bivalirudin has comparable anticoagulant effect as heparin during perioperation of PCI in ACS patients with renal dysfunction,and can effectively reduce the incidence of postoperative bleeding after PCI.