Department of Cardiology, University of Arkansas for Medical Sciences, Little Rock, Arkansas.
Department of Medicine, New York Medical College-Metropolitan Hospital Center, New York, New York.
Am J Cardiol. 2014 Jul 15;114(2):250-9. doi: 10.1016/j.amjcard.2014.04.033. Epub 2014 May 2.
This study sought to investigate the relative safety and efficacy of bivalirudin versus heparin plus glycoprotein (GP) IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention (PCI) and in those with ST-segment elevation myocardial infarction (STEMI). The safety of bivalirudin in PCI, particularly in patients with STEMI, continues to be debated. We searched the on-line databases for randomized controlled trials of bivalirudin versus heparin plus GP IIb/IIIa inhibitors. Data on study design, inclusion and exclusion criteria, sample characteristics, and clinical outcomes at 30 days were extracted. A total of 19,856 PCI patients included in 7 randomized trials and 5,820 patients with STEMI included in 2 randomized trials were separately analyzed. At 30 days, bivalirudin use in patients undergoing PCI resulted in similar rates of death, myocardial infarction, repeat revascularization, and stent thrombosis. In patients with STEMI, bivalirudin use resulted in decreased cardiac mortality (risk ratio [RR] 0.70, 95% confidence interval [CI] 0.50 to 0.97, p=0.03) compared with heparin plus GP IIb/IIIa inhibitors but an increase in definite stent thrombosis at 30 days (RR 1.88, 95% CI 1.09 to 3.24, p=0.02) driven by an increase in acute stent thrombosis (RR 5.48, 95% CI 2.30 to 13.07, p=0.0001). Bivalirudin use was associated with a decrease in Thrombolysis In Myocardial Infarction (TIMI) major (RR 0.58, 95% CI 0.46 to 0.74, p<0.0001) and TIMI minor (RR 0.55, 95% CI 0.48 to 0.63, p<0.0001) bleeding rates in PCI patients as well as in a subgroup of patients with STEMI. In conclusion, in PCI patients anticoagulation with bivalirudin results in similar ischemic adverse events and a reduction in TIMI major and minor bleeding at 30 days compared with heparin plus GP IIb/IIIa inhibitors. In patients with STEMI, bivalirudin use is associated with a reduction in TIMI major and minor bleeding and fewer deaths from cardiac causes but an increase in acute and 30-day definite stent thrombosis.
本研究旨在探讨经皮冠状动脉介入治疗（PCI）患者及 ST 段抬高型心肌梗死（STEMI）患者中比伐卢定与肝素加糖蛋白（GP）IIb/IIIa 抑制剂的相对安全性和疗效。比伐卢定在 PCI 中的安全性，特别是在 STEMI 患者中的安全性，仍存在争议。我们在线数据库中检索了比伐卢定与肝素加 GP IIb/IIIa 抑制剂的随机对照试验。提取研究设计、纳入和排除标准、样本特征以及 30 天临床结局的数据。分别分析了 7 项随机试验纳入的 19856 例 PCI 患者和 2 项随机试验纳入的 5820 例 STEMI 患者。30 天时，行 PCI 的患者使用比伐卢定后死亡率、心肌梗死、再次血运重建和支架血栓形成的发生率相似。与肝素加 GP IIb/IIIa 抑制剂相比，STEMI 患者使用比伐卢定可降低心脏死亡率（风险比 [RR]0.70，95%置信区间 [CI]0.50 至 0.97，p=0.03），但 30 天时明确的支架血栓形成发生率增加（RR1.88，95%CI1.09 至 3.24，p=0.02），这主要是由于急性支架血栓形成增加（RR5.48，95%CI2.30 至 13.07，p=0.0001）。比伐卢定的使用与 PCI 患者以及 STEMI 亚组的 TIMI 主要（RR0.58，95%CI0.46 至 0.74，p<0.0001）和 TIMI 次要（RR0.55，95%CI0.48 至 0.63，p<0.0001）出血率降低相关。总之，与肝素加 GP IIb/IIIa 抑制剂相比，PCI 患者抗凝使用比伐卢定可在 30 天时降低缺血性不良事件和 TIMI 主要及次要出血的发生率。在 STEMI 患者中，与肝素加 GP IIb/IIIa 抑制剂相比，比伐卢定的使用与 TIMI 主要和次要出血减少以及心脏原因导致的死亡减少相关，但急性和 30 天明确的支架血栓形成增加相关。
