比伐卢定在冠状动脉分叉病变介入治疗中的疗效观察

Efficacy and safety of bivalirudin in percutaneous coronary intervention for coronary bifurcation lesions

目的观察比伐卢定应用于冠状动脉分叉病变介入治疗中的有效性和安全性。方法本研究为回顾性队列研究,连续纳入2016年1~12月于本所经冠脉造影明确的329例冠脉分叉病变介入治疗患者。按照抗凝方式不同分为肝素组(178例)和比伐卢定组(151例)。统计两组患者的临床资料特征(性别、年龄、危险因素等)与冠脉病变情况,并随访两组患者PCI术后24 h、7 d、1年的主要不良心血管事件(major adverse cardiovascular events, MACE)及出血发生事件,其中MACE包括:死亡、心肌梗死、靶血管再次血管重建、脑卒中,而出血事件参照BARC出血分级标准进行评估。结果两组患者在人口学资料、既往病史、ACS比例、重要实验室指标和药物治疗方面基线数据差异无统计学意义。在分叉病变特征方面,两组患者的分叉病变位置、分叉病变类型、真分叉比例、主支及分支血管的长度和直径差异均无统计学意义。在PCI术后24 h内及1周内,两组均无MACE发生;肝素组有3例患者出现出血事件,无主要出血事件发生;比伐卢定组有5例患者出现出血事件,主要出血事件1例;两组间差异无统计学意义(P=0.477,P=0.459)。随访12个月后,肝素组有20例患者出现MACE,比伐卢定组有15例患者出现MACE,多因素分析显示比伐卢定对分叉病变冠脉介入治疗术后的MACE较肝素组无明显差异(HR=0.839,95%CI:0.420~1.676,P=0.619)。随访12个月后,肝素组有49例患者出现出血事件,主要出血事件6例;比伐卢定组有27例患者出现出血事件,主要出血事件3例;多因素分析显示比伐卢定较肝素显著减少分叉病变介入术后患者出血事件的风险(HR=0.557,95%CI:0.355~0.937,P=0.026);而在主要出血事件风险方面,两者间无明显差异(HR=0.535,95%CI:0.130~2.206,P=0.387)。结论对冠状动脉分叉病变介入治疗患者随访12个月,比伐卢定较普通肝素显著降低出血风险,而并不增加MACE发生率。

Objective To investigate the efficacy and safety of bivalirudin in percutaneous coronary intervention(PCI) for coronary bifurcation lesions. Methods This retrospective cohort study was conducted among 329 consecutive patients with coronary artery bifurcation lesions confirmed by coronary angiography and underwent PCI in our institute between January, 2016 and December, 2016. All the patients received anticoagulation treatment with bivalirudin(151 cases) or heparin(178 cases). The demographic and clinical data of the patients(including gender, age, and risk factors) and the conditions of the coronary artery lesions were compared between the 2 groups. In 24 h, 7 d and 12 months after the procedure, the incidences of main adverse cardiovascular events(MACE, including death, myocardial infarction, revascularization of the target vessel, and stroke) and bleeding were recorded after PCI. The bleeding endpoint was assessed in line with the BARC criteria for grading bleeding. Results No significant differences were found between the 2 groups in the baseline data(including the demographic data, medical history, proportion of acute coronary syndrome, important laboratory indicators, and drug treatment), nor in the characteristics of bifurcation lesions(including the lesion position, lesion type, true bifurcation ratio, length and diameter of the main branches and the branch vessels). In 24 h and 1 week after PCI, no MACE occurred in both groups. Bleeding and observed in 3 cases of the heparin group, but no major bleeding event was seen. In the bivalirudin group, there were 5 cases experiencing bleeding and 1 having major bleeding event. But no significant differonce was seen between the 2 groups(P=0.447, P=0.459). Within 12 months after PCI, MACE occurred in 20 patients in the heparin group and in 15 patients in the bivalirudin group. Multivariate analysis showed that bivalirudin did not significantly affect the incidence of MACE after PCI compared with heparin(HR=0.839, 95%CI: 0.420-1.676, P=0.619). During the 12-month follow-up, 49 patients in the heparin group had bleeding events(including major bleeding events in 6 patients), as compared with 27 patients in the bivalirudin group(including 3 major bleeding events). Multivariate analysis further showed that compared with heparin, bivalirudin significantly reduced the risk of bleeding events in patients with bifurcation lesions after PCI(HR=0.557, 95%CI: 0.355-0.937, P=0.026), but did not significantly affect the risk of major bleeding events(HR=0.535, 95%CI: 0.130-2.206, P=0.387). Conclusion In patients undergoing PCI for coronary bifurcation lesions, anticoagulation therapy with bivalirudin significantly reduces the risk of bleeding as compared with unfractionated heparin without increasing the incidences of MACE at 12 months after PCI.