Department of Medicine, Division of Cardiovascular Medicine, New York University School of Medicine, 530 First Avenue, New York, NY 10016, USA.
Circ Cardiovasc Interv. 2011 Oct 1;4(5):463-73. doi: 10.1161/CIRCINTERVENTIONS.111.961912. Epub 2011 Oct 4.
Prior randomized trials have shown reduced bleeding with bivalirudin compared with unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI). However, it is not known if this benefit is also present when UFH doses are more tightly controlled (as measured by activated clotting time, ACT).
Patients enrolled in the EVENT (Evaluation of Drug-Eluting Stents and Ischemic Events) registry, were divided into 3 groups, based on the antithrombotic drug used during PCI (UFH monotherapy, UFH+glycoprotein IIb-IIIa receptor inhibitor [GPI], or bivalirudin alone). Propensity score matching was used to adjust for measured covariates (89 variables) and to compare bivalirudin versus UFH monotherapy and bivalirudin versus UFH+GPI groups. The UFH groups were stratified based on ACT achieved (optimal ACT defined as 250-300 for UFH monotherapy and 200-250 when GPI was also used). The primary bleeding outcome was in-hospital composite bleeding, defined as events of access site bleeding, Thrombolysis In Myocardial Infarction major/minor bleeding, or transfusion. Primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/MI/unplanned repeat revascularization at 12 months) were also evaluated. Propensity score matching yielded 3022 patients for the UFH monotherapy versus bivalirudin comparison and 3520 patients for the UFH+GPI versus bivalirudin comparison. Bivalirudin use was associated with numerically lower bleeding rates at all categories of achieved ACT when compared with UFH (low, optimal, high ACT: 2.5% versus 4.7%, 1.9% versus 6.0%, 3.1% versus 4.8%, respectively) or heparin+GPI groups (low, optimal, high ACT: 0.0% versus 2.7%, 2.7% versus 5.2%, 2.4% versus 6.1%, respectively) and was not associated with any statistically significant increase in either primary or secondary ischemic outcomes.
Among unselected patients undergoing PCI, bivalirudin use during PCI was associated with a lower risk of bleeding at all comparator ACT levels without an increase in ischemic outcomes.
先前的随机试验表明，与未分级肝素（UFH）相比，接受经皮冠状动脉介入治疗（PCI）的患者使用比伐卢定可减少出血。然而，当 UFH 剂量（通过激活凝血时间，ACT）更严格控制时，是否存在这种益处尚不清楚。
EVENT（药物洗脱支架和缺血事件评估）登记处纳入的患者根据 PCI 期间使用的抗血栓药物（UFH 单药治疗、UFH+糖蛋白 IIb-IIIa 受体抑制剂[GPI]或比伐卢定单药）分为 3 组。使用倾向评分匹配来调整测量协变量（89 个变量），并比较比伐卢定单药与 UFH 单药治疗以及比伐卢定单药与 UFH+GPI 组。UFH 组根据达到的 ACT 分层（UFH 单药治疗的最佳 ACT 定义为 250-300，当 GPI 也使用时为 200-250）。主要出血结局为住院期间复合出血，定义为穿刺部位出血、心肌梗死溶栓治疗大出血/小出血或输血事件。主要（住院死亡/心肌梗死）和次要缺血结局（12 个月时死亡/心肌梗死/计划外再次血运重建）也进行了评估。倾向评分匹配得到 UFH 单药治疗与比伐卢定比较的 3022 例患者和 UFH+GPI 与比伐卢定比较的 3520 例患者。与 UFH（低、最佳、高 ACT：2.5%对 4.7%、1.9%对 6.0%、3.1%对 4.8%）或肝素+GPI 组（低、最佳、高 ACT：0.0%对 2.7%、2.7%对 5.2%、2.4%对 6.1%）相比，比伐卢定使用与所有达到的 ACT 类别中出血率降低相关（低、最佳、高 ACT：0.0%对 2.7%、2.7%对 5.2%、2.4%对 6.1%），并且与主要或次要缺血结局的任何统计学显著增加无关。
在接受 PCI 的未选择患者中，PCI 期间使用比伐卢定与所有比较 ACT 水平的出血风险降低相关，而缺血结局无增加。
