经皮冠状动脉介入治疗中比伐芦定与肝素钠的抗凝效果和安全性比较

Comparison on anticoagulant efficacy and safety between bivalirudin and heparin during percutaneous coronary intervention

摘要:

目的 比较经皮冠状动脉介入(PCI)治疗中应用比伐芦定与肝素钠抗凝的有效性和安全性。方法 连续纳入100例择期PCI患者作为研究对象,随机数表法将患者分为比伐芦定组(50例)和肝素钠组(50例),分别于给药后15、30、60min及手术结束时监测活化凝血时间(ACT),观察围术期出血事件及主要不良心血管事件(MACE)发生情况。应用SPSS 20.0统计软件进行数据分析。结果 给药15min后2组患者ACT值均达标。术中比伐芦定组ACT水平基本稳定维持在较高水平[15min:(280.5±12.5) s；30min:(279.5±5.5)s；60min:(282.1±6.8)s；手术结束时:(275.3±9.9)s],而肝素钠组ACT水平持续下降[15min:(276.6±6.1)s；30min:(258.1±3.0)s；60min:(241.8±8.6)s；手术结束时:(234.9±7.9)s],给药30min后2组ACT值的差异均具有统计学意义(P＜0.001)。2组术中及术后24h内出血事件及血栓性事件的发生率无统计学差异(P＞0.05)。 结论 比伐芦定与肝素钠在PCI术中均安全有效。应用比伐芦定ACT数值较为稳定；而应用肝素钠时ACT数值波动较为明显,建议间隔15min复测ACT为宜。

Abstract:

Objective To compare the anticoagulant efficacy and safety of bivalirudin and heparin during percutaneous coronary intervention (PCI). Methods A total of 100 consecutive patients hospitalized in our center due to unstable angina from December 1st to 31st, 2018, and undergoing elective PCI were enrolled in this study. They were randomly divided into bivalirudin group (n=50) and heparin group (n=50). Their activated coagulation time (ACT) was monitored at 15,30, 60min after administration and at the end of the operation, and the occurrence of perioperative bleeding events and major adverse cardiovascular events (MACE) were observed. SPSS statistics 20.0 was used for data analysis.Results After 15min of administration, the ACT were up to the standard time in both groups. The ACT levels remained stable in the bivalirudin group [15min:(280.5±12.5)s; 30min:(279.5±5.5)s; 60min:(282.1±6.8)s; end of operation:(275.3±9.9)s], while those of heparin group continued to decline [15min:(276.6±6.1)s; 30min:(258.1±3.0)s; 60min:(241.8±8.6)s; end of operation:(234.9±7.9)s]. Significant difference was seen in ACT between the 2 groups from 30 min after administration (P＜0.001). There were no obvious differences in the prevalence of hemorrhagic events and thrombotic events between the 2 groups (P＞0.05). Conclusion Both bivalirudin and heparin are efficient and safe anticoagulants during PCI, and the former can obtain more stable ACT. While, for the latter, ACT should be monitored every 15 min due to its obvious fluctuation during the whole operation.