Abtahian Farhad, Waldo Stephen, Jang Ik-Kyung
Cardiology Division, Massachusetts General Hospital and Harvard Medical School, Boston, Massachuttes.
Catheter Cardiovasc Interv. 2015 Sep;86(3):390-6. doi: 10.1002/ccd.25911. Epub 2015 Mar 30.
The primary objective of this study is the compare the association between bleeding and the use unfractionated heparin (UFH) versus bivalirudin during percutaneous coronary intervention (PCI).
In patients undergoing PCI, the risk of bleeding with use of bivalirudin compared with UFH in the absence of glycoprotein IIb/IIIa inhibitors is not well defined.
Patients undergoing PCI with either UFH or bivalirudin monotherapy at a single institution between 2007 and 2014 were included (n = 6,143). Propensity score matching was used to adjust for baseline characteristics yielding 2,984 well matched patients (1,492 in each group). The primary endpoint was major non-coronary artery bypass graft (non-CABG) related bleeding as defined by a Bleeding Academic Consortium type 3 or 5. Secondary outcomes included combined major and minor bleeding, in-hospital death, periprocedural myocardial infarction, and recurrent ischemia requiring urgent revascularization (repeat PCI).
In the propensity matched cohort, there was no difference in major bleeding between UFH and bivalirudin monotherapy (1.8% versus 2.4%, P = 0.305). Combined major and minor bleeding was also similar between the two groups (4.3% versus 4.3%, P = 1.0). Likewise, no differences were observed between the bivalirudin and UFH groups in terms of in-hospital death (0.4% versus 0.5%, P = 0.592), periprocedural myocardial infarction (1.5% versus 2.0%, P = 0.332) and repeat PCI (0.7% versus 0.8%, P = 0.669).
Among patients undergoing PCI, there was no significant difference in rate of bleeding between bivalirudin and heparin monotherapy in a real-world setting.
本研究的主要目的是比较经皮冠状动脉介入治疗（PCI）期间出血与使用普通肝素（UFH）和比伐卢定之间的关联。
在接受PCI的患者中，在不使用糖蛋白IIb/IIIa抑制剂的情况下，与UFH相比，使用比伐卢定的出血风险尚未明确界定。
纳入2007年至2014年期间在单一机构接受UFH或比伐卢定单药治疗的PCI患者（n = 6,143）。采用倾向评分匹配来调整基线特征，产生2,984例匹配良好的患者（每组1,492例）。主要终点是出血学术联盟3型或5型定义的主要非冠状动脉搭桥术（非CABG）相关出血。次要结局包括主要和次要出血合并、住院死亡、围手术期心肌梗死以及需要紧急血运重建（重复PCI）的复发性缺血。
在倾向匹配队列中，UFH和比伐卢定单药治疗之间的主要出血无差异（1.8%对2.4%，P = 0.305）。两组之间的主要和次要出血合并情况也相似（4.3%对4.3%，P = 1.0）。同样，比伐卢定组和UFH组在住院死亡（0.4%对0.5%，P = 0.592）、围手术期心肌梗死（1.5%对2.0%，P = 0.332）和重复PCI（0.7%对0.8%，P = 0.669）方面均未观察到差异。
在接受PCI的患者中，在现实世界中比伐卢定和肝素单药治疗之间的出血率无显著差异。
