[Efficacy of periprocedural bivalirudin infusion in patients with chronic total occlusion lesion undergoing percutaneous coronary intervention].

Objective: To investigate the efficacy of periprocedural use of bivalirudin for patients with chronic total occlusion(CTO) lesion undergoing percutaneous coronary intervention(PCI) therapy. Methods: In this randomized controlled study, 74 patients with CTO lesions confirmed by coronary angiography or CT angiography, hospitalized in the general hospital of Shenyang military region from September 2015 to December 2016, were randomly divided into unfractionated heparin(UFH) group (n=38) and bivalirudin group (n=36) by the random number table.Patients in the UFH group were treated with injection of UFH 5 000 U through the artery sheath catheter before coronary angiography,and the UFH was intravenously administered at 100 U/kg before PCI. Patients in the bivalirudin group received intravenous injection of bivalirudin (0.75 mg/kg) before coronary angiography, followed by intravenous infusion of 1.75 mg·kg(-1)·h(-1) until at least 2 hours after the PCI. The values of the activated coagulation time (ACT) were measured,and the value was remained at 250 to 350 seconds during the PCI. The incidence rate of adverse events including hemorrhage events, no-reflow/slow flow, and contact thrombus in perioperative period were observed in all patients. In addition, the incidence rate of the major adverse cardiovascular events (MACE) including recurrent angina, heart failure, target vessel revascularization, cardiac death, non-fatal myocardial infarction,and stroke within 1 year follow-up period were also observed in the 2 groups. Results: Baseline clinical and PCI data were similar between the 2 groups (all P>0.05). During the perioperative period, the incidence of the bleeding was significantly lower in the bivalirudin group than in the UFH group(5.6% (2/36) vs. 23.7% (9/38) , P=0.028).The incidence of no-reflow/slow flow was also significantly lower in the bivalirudin group than in the UFH group(0 vs. 15.8% (6/38) , P=0.025). There was no significant difference in the incidence of contact thrombosis between bivalirudin group and UFH group(8.3% (3/36) vs. 0, P=0.110). There was no cardiac death or non-fatal myocardial infarction in the 2 groups within 1 year after PCI, and there was no significant difference in the incidence of MACE in 1 year follow-up after operation between bivalirudin group and UFH group (11.1% (4/36) vs. 21.1% (8/38) , P=0.246). Conclusion: The application of the anticoagulant bivalirudin during PCI in patients with CTO lesion can reduce the incidence of perioperative bleeding and no-reflow/slow flow, and does not increase the risk of MACE within 1 year after PCI.目的： 探讨比伐芦定在冠状动脉慢性完全闭塞（CTO）病变经皮冠状动脉介入治疗（PCI）中应用的疗效。 方法： 采用随机对照研究方法，入选2015年9月至2016年12月在沈阳军区总医院经冠状动脉造影或CT血管成像证实的CTO病变患者74例。将入选患者按随机数字表法分为普通肝素组（冠状动脉造影前经鞘管注射普通肝素5 000 U，PCI前按100 U/kg经静脉补充普通肝素，共38例）和比伐芦定组（冠状动脉造影前经静脉推注比伐芦定0.75 mg/kg，然后以1.75 mg·kg(-1)·h(-1)持续静脉滴注至手术结束后至少2 h，共36例）。术中检测活化凝血时间（ACT）值，使其维持在250~350 s。观察两组患者围手术期发生的不良事件，包括出血、冠状动脉无复流/慢血流和接触性血栓。术后随访1年，观察主要不良心血管事件（MACE，包括再发心绞痛、心力衰竭、靶血管再次血运重建、心原性死亡、非致死性心肌梗死和卒中）的发生率。 结果： 两组间的基线资料和PCI情况差异均无统计学意义（P均>0.05）。围手术期，比伐芦定组出血事件发生率低于普通肝素组[5.6%（2/36）比23.7%（9/38），P=0.028]。比伐芦定组术中冠状动脉无复流/慢血流发生率低于普通肝素组[0比15.8%（6/38），P=0.025]。比伐芦定组与普通肝素组间的接触性血栓[8.3%（3/36）比0，P=0.110]发生率差异无统计学意义。术后1年内，比伐芦定组和普通肝素组均未出现心原性死亡和非致死性心肌梗死，两组之间的MACE发生率差异无统计学意义[11.1%（4/36）比21.1%（8/38），P=0.246]。 结论： 冠状动脉CTO病变患者在PCI术中应用比伐芦定抗凝，能够降低围手术期出血和无复流/慢血流发生率，同时不增加术后1年发生MACE的风险。.