Columbia University Medical Center, New York, New York; The Cardiovascular Research Foundation, New York, New York.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
J Am Coll Cardiol. 2014;63(1):15-20. doi: 10.1016/j.jacc.2013.09.027. Epub 2013 Oct 16.
The purpose of this study was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH+GPI) can be fully attributed to reduced bleeding.
The association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin.
A total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH+GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding.
When compared with UFH+GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs. 10.5%, hazard ratio [HR]: 0.64 [95% confidence interval (CI): 0.51 to 0.80], p < 0.0001) and cardiac mortality (2.9% vs. 5.1%, HR: 0.56 [95% CI: 0.40 to 0.80], p = 0.001). Three-year cardiac mortality was reduced in bivalirudin-treated patients with major bleeding (20 fewer deaths with bivalirudin; 5.8% vs. 14.6%, p = 0.025) and without major bleeding (18 fewer deaths with bivalirudin; 2.6% vs. 3.8%, p = 0.048). In a fully-adjusted multivariable model accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR: 0.57 [95% CI: 0.39 to 0.83], p = 0.003).
Bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966).
本研究旨在确定在接受直接经皮冠状动脉介入治疗（PCI）的 ST 段抬高型心肌梗死（STEMI）患者中，与未分馏肝素加糖蛋白 IIb/IIIa 抑制剂（UFH+GPI）相比，使用比伐卢定降低心脏死亡率是否可以完全归因于出血减少。
出血并发症与死亡率之间的关联可能解释了比伐卢定的生存获益。
共有 3602 例接受直接 PCI 的 STEMI 患者被随机分为比伐卢定组和 UFH+GPI 组。分析了有和无主要出血的患者 3 年的心脏死亡率。
与 UFH+GPI 相比，比伐卢定导致 3 年的主要出血率更低（6.9%比 10.5%，风险比[HR]：0.64[95%置信区间（CI）：0.51 至 0.80]，p<0.0001）和心脏死亡率（2.9%比 5.1%，HR：0.56[95%CI：0.40 至 0.80]，p=0.001）。在接受比伐卢定治疗的有大出血的患者中（比伐卢定组有 20 例死亡，而 UFH+GPI 组有 30 例死亡；5.8%比 14.6%，p=0.025）和无大出血的患者中（比伐卢定组有 18 例死亡，而 UFH+GPI 组有 26 例死亡；2.6%比 3.8%，p=0.048），3 年的心脏死亡率降低。在一个充分调整的多变量模型中，考虑到大出血和其他不良事件，比伐卢定仍然与 3 年的心脏死亡率降低 43%相关（调整后的 HR：0.57[95%CI：0.39 至 0.83]，p=0.003）。
在接受直接 PCI 的 STEMI 患者中，比伐卢定降低心脏死亡率，这种作用只能部分归因于出血的预防。需要进一步研究以确定比伐卢定的非血液学益处。（急性心肌梗死中血管重建和支架的效果协调；NCT00433966）。
