Xu Haiyan, Wang Bingjian, Yang Jing, Ma Shuren, Xie Xiongwei
Department of Cardiology, Huai'an First People's Hospital, Nanjing Medical University, Huai'an, Jiangsu, P. R. China.
PLoS One. 2017 Jan 17;12(1):e0169951. doi: 10.1371/journal.pone.0169951. eCollection 2017.
Bivalirudin has been shown to be safe and efficacious compared with heparin plus glycoprotein IIb/IIIa inhibitor (GPI) in patients undergoing percutaneous coronary intervention (PCI). Whether bivalirudin would have the beneficial effects in female patients undergoing PCI remains unknown. We searched the literature for randomized controlled trials that assessed bivalirudin versus heparin plus GPI therapy in female patients undergoing PCI. The primary efficacy end point was major adverse cardiovascular events (MACE) within 30 days. The secondary efficacy end points were 30-day incidence of all-cause mortality, myocardial infarction (MI), urgent/ischemia-driven revascularization of target vessel. The safety end point was major bleeding up to 30 days. A total of 4,501 female patients were included in five randomized trials. No significant difference in MACE emerged between bivalirudin and heparin plus GPI at 30 days (8.15% vs 8.76%, RR 0.94, 95% CI 0.77-1.16, P = .57). There were no significant differences in rates of mortality (1.28% vs 1.91%, RR 0.74, 95% CI 0.45-1.20, P = .22), MI (5.46% vs 5.25%, RR 1.02, 95% CI 0.79-1.32, p = .88), or target vessel revascularization (2.13% vs 1.65%, RR 1.43, 95% CI 0.88-2.30, P = .15). Compared with heparin plus GPI, bivalirudin was associated with a significant reduction in 30-day major bleeding (5.32% vs 9.20%, RR 0.58, 95% CI 0.47-0.72, P < .0001). In conclusion, bivalirudin is associated with a significant reduction in 30-day major bleeding without increased ischemic events compared with heparin plus GPI in female patients undergoing PCI.
与肝素加糖蛋白IIb/IIIa抑制剂（GPI）相比，比伐卢定已被证明在接受经皮冠状动脉介入治疗（PCI）的患者中是安全有效的。比伐卢定在接受PCI的女性患者中是否具有有益效果仍不清楚。我们检索了文献，以寻找评估比伐卢定与肝素加GPI疗法在接受PCI的女性患者中的随机对照试验。主要疗效终点是30天内的主要不良心血管事件（MACE）。次要疗效终点是30天全因死亡率、心肌梗死（MI）、目标血管紧急/缺血驱动的血运重建的发生率。安全终点是30天内的大出血。五项随机试验共纳入4501名女性患者。30天时，比伐卢定与肝素加GPI在MACE方面无显著差异（8.15%对8.76%，RR 0.94，95%CI 0.77-1.16，P = 0.57）。在死亡率（1.28%对1.91%，RR 0.74，95%CI 0.45-1.20，P = 0.22）、MI（5.46%对5.25%，RR 1.02，95%CI 0.79-1.32，P = 0.88）或目标血管血运重建（2.13%对1.65%，RR 1.43，95%CI 0.88-2.30，P = 0.15）方面也无显著差异。与肝素加GPI相比，比伐卢定与30天大出血显著减少相关（5.32%对9.20%，RR 0.58，95%CI 0.47-0.72，P < 0.0001）。总之，与肝素加GPI相比，比伐卢定在接受PCI的女性患者中与30天大出血显著减少相关，且缺血事件未增加。
