Patel Hiten, Garris Rana, Bhutani Suchit, Shah Priyank, Rampal Upamanyu, Vasudev Rahul, Melki Gabriel, Ghalyoun Bader Abu, Virk Hartaj, Bikkina Mahesh, Shamoon Fayez
Department of Cardiology, Cape Fear Valley Medical Center, Campbell University, Fayetteville, NC, USA.
St Joseph's Health, New York Medical College, Paterson, NJ, USA.
Cardiol Res. 2019 Oct;10(5):278-284. doi: 10.14740/cr921. Epub 2019 Oct 4.
The aim of the study was to compare the efficacy and safety of bivalirudin versus unfractionated heparin (UFH) in patients with acute myocardial infarction who undergo percutaneous coronary intervention (PCI). Earlier trials comparing bivalirudin and UFH during PCI demonstrated that bivalirudin caused less bleeding with more stent thrombosis. Since then, adjunct antiplatelet strategies have evolved. Improved upstream platelet inhibition with potent P2Y12 inhibitors decreased the need for routine glycoprotein IIb/IIIa inhibitor (GPI), resulting in similar outcomes among UFH and bivalirudin. Therefore, the role of bivalirudin in modern PCI practices is questionable.
We utilized Cochrane Review Manager (RevMan) 5.3 to perform a meta-analysis of seven randomized controlled trials (RCTs) with 22,844 patients to compare bivalirudin to UFH in patients with acute myocardial infarction requiring revascularization.
There was no difference between bivalirudin and UFH regarding major adverse cardiac events (MACE), risk ratio (RR) 0.99, 95% confidence interval (CI) 0.87 - 1.12; P = 0.83) or cardiovascular mortality (RR 0.87, 95% CI 0.71 - 1.07; P = 0.18). Bivalirudin increased acute stent thrombosis (RR 2.77, 95% CI 1.49 - 5.13; P = 0.001), which was only significant among ST-elevation myocardial infarction (STEMI) only trials. Bivalirudin caused less major bleeding (RR 0.66, 95% CI 0.49 - 0.90; P = 0.007), which was negated when GPI was used provisionally (RR 0.93, 95% CI 0.64 - 1.33; P = 0.67).
Among patients with acute myocardial infarction who underwent PCI, bivalirudin and UFH demonstrated similar MACE and cardiovascular mortality. Bivalirudin increased acute stent thrombosis, which was more remarkable among STEMI. Bivalirudin decreased major bleeding, but this benefit was negated when GPI was used provisionally.
本研究旨在比较比伐卢定与普通肝素（UFH）在接受经皮冠状动脉介入治疗（PCI）的急性心肌梗死患者中的疗效和安全性。早期在PCI期间对比比伐卢定和UFH的试验表明，比伐卢定导致的出血较少，但支架血栓形成较多。从那时起，辅助抗血小板策略不断发展。使用强效P2Y12抑制剂改善上游血小板抑制作用减少了常规糖蛋白IIb/IIIa抑制剂（GPI）的使用需求，导致UFH和比伐卢定的治疗结果相似。因此，比伐卢定在现代PCI实践中的作用值得怀疑。
我们利用Cochrane系统评价管理软件（RevMan）5.3对7项随机对照试验（RCT）进行荟萃分析，这些试验涉及22844例患者，以比较比伐卢定与UFH在需要血运重建的急性心肌梗死患者中的疗效。
比伐卢定与UFH在主要不良心脏事件（MACE）方面无差异，风险比（RR）为0.99，95%置信区间（CI）为0.87 - 1.12；P = 0.83）或心血管死亡率方面也无差异（RR 0.87，95%CI 0.71 - 1.07；P = 0.18）。比伐卢定增加了急性支架血栓形成（RR 2.77，95%CI 1.49 - 5.13；P = 0.001），这仅在仅纳入ST段抬高型心肌梗死（STEMI）患者的试验中具有统计学意义。比伐卢定导致的严重出血较少（RR 0.66，95%CI 0.49 - 0.90；P = 0.007），但在临时使用GPI时这种差异消失（RR 0.93，95%CI 0.64 - 1.33；P = 0.67）。
在接受PCI的急性心肌梗死患者中，比伐卢定和UFH的MACE和心血管死亡率相似。比伐卢定增加了急性支架血栓形成，在STEMI患者中更为显著。比伐卢定减少了严重出血，但在临时使用GPI时这种益处消失。
