冠脉介入治疗围手术期应用比伐芦定的中国急性心肌梗死患者临床显著出血事件独立预测因素分析

Predictors of clinically significant bleeding events in bivalirudin-treated Chinese patients with acute myocardial infarction undergoing percutaneous coronary intervention

目的本研究旨在进一步观察在PCI围手术期应用比伐芦定急性心肌梗死患者中，术后30d内临床显著出血事件的独立预测因素。方法纳入自2012年8月至2015年12月间，在中国88家心脏中心接受PCI治疗且在围手术期应用比伐芦定的急性心肌梗死连续病例共3023例，主要观察指标为术后30d内发生的需临床干预的显著出血事件，即按出血学术研究联合会（BARC）等级划分的2—5型出血事件，并应用多因素Logistic回归方程分析临床显著出血事件的独立预测因素。结果30d随访期内，共有88例（2．9％）的患者发生了出血事件，其中需临床干预的显著出血（BARC2～5）22例（0．7％），BARC3～5型的大出血7例（0．2％）。多因素Logistic回归分析发现桡动脉穿刺路径（OR：0．196，95％CI：0．074～0．517，P=0．001）明显有助于减少临床显著出血事件的发生，贫血（OR：2．956，95％（21：1．024—8．528，P=0．045）以及eGFR〈30mL／min（OR：7．860，95％CI：1．515—40．776，P=0．014）为临床显著出血事件的独立危险因素。结论在PCI围手术期应用比伐芦定的急性心肌梗死患者中，临床显著的出血事件发生率被控制在较低水平，桡动脉穿刺路径是降低显著出血的独立保护因素，贫血和eGFR〈30ml／min增加显著出血的发生危险。

Objective This study was designed to further clarify the independent predictors of clinically significant bleeding events in bivalirudin-treated patients with acute myocardial infarction （AMI） undergoing percutaneous coronary intervention （ PCI）. Methods A total of 3 023 AMI patients from 88 centers of China who underwent PCI and received periproeedural bivalirudin treatment between August 2012 and December 2015 were involved in this study. The primary outcome was clinically significant bleeding events defined as the Bleeding Academic Research Consortium （BARC） grades 2 -5, with 30 days after PCI. A multivariate Logistic regression model was performed to identify the independent predictors of the primary outcome. Results Bleeding events occurred in 88 （2.9%） patients during the 30-day follow up, with clinically significant bleeding （ BARC types 2 - 5 ） in 22 （ 0. 7% ） and BARC types 3 - 5 in 7 （ 0. 2% ）. Multivariate regression analysis revealed radial access （ OR ：0. 196, 95 % CI：0. 074 - 0. 517, P = 0. 001 ） as the independent protector of the significant bleeding events, anemia （ OR ： 2. 956,95% CI： 1. 024 - 8. 528, P = 0. 045 ） and eGFR 〈 30 ml/min （OR ：7. 860,95 % CI：1. 515 - 40. 776, P = 0. 014） as independent risk factors. Conclusions The rate of clinically significant bleeding complications in Chinese AMI patients undergoing PCI with concomitant use of bivalirudin is low in real-world clinical practice. Radial access is independent protective factor that reduces bleeding events, whereas anemia and eGFR 〈 30 ml/min are independent risk factors that increase bleeding risk.