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比伐芦定与肝素用于接受经皮冠状动脉介入治疗的女性患者:随机临床试验的系统评价和荟萃分析

Bivalirudin versus heparin in women undergoing percutaneous coronary intervention: A systematic review and meta-analysis of randomized clinical trials.

作者信息

Saad Marwan, Nairooz Ramez, Rashed Ahmed, Abdelaziz Hesham K, Mentias Amgad, Abbott J Dawn

机构信息

Department of Medicine, Division of Cardiovascular Medicine, University of Arkansas for Medical Sciences, Little Rock, AR, USA.

Department of Medicine, Division of Cardiovascular Medicine, Wayne State University/Detroit Medical Center, Detroit, MI, USA.

出版信息

Cardiovasc Revasc Med. 2017 Sep;18(6):418-424. doi: 10.1016/j.carrev.2017.02.019. Epub 2017 Feb 28.

Abstract

BACKGROUND

The anticoagulant of choice during percutaneous coronary intervention (PCI) in women is not well established.

METHODS

An electronic search was conducted for trials that randomized patients undergoing PCI to bivalirudin versus heparin, and reported outcomes of interest in women. Random effects DerSimonian-Laird risk ratios (RR) were calculated. Main outcome was net adverse clinical events (NACE) at 30-days. Other outcomes included major adverse cardiac events (MACE), all-cause mortality, myocardial infarction (MI), target vessel revascularization (TVR), and major bleeding at 30-days. 1-year all-cause mortality and MACE were also examined.

RESULTS

Nine trials that randomized women undergoing PCI to bivalirudin (n=3960) versus heparin (n=4050) were included. At 30-days, bivalirudin was associated with reduced risk of NACE (RR=0.85; 95% CI 0.73-0.98; p=0.03), mainly driven by reduction in major bleeding (RR=0.59; 95% CI 0.49-0.71; p<0.001) compared with heparin. No difference in MACE (p=0.92), all-cause mortality (p=0.23), MI (p=0.86); or TVR (p=0.53) was demonstrated between both groups. At 1-year, the risk of MACE and all-cause mortality was similar in both groups. On a subgroup analysis, the benefit associated with bivalirudin appeared to be less evident when Glycoprotein IIb/IIIa inhibitors (GPI) was used as bailout therapy with heparin, however without significant interaction. Furthermore, in STEMI population, no difference in NACE, MACE, or major bleeding was observed between both groups.

CONCLUSION

In women undergoing PCI, bivalirudin is associated with reduced risk of major bleeding and NACE compared with heparin especially when GPI is routinely used.

摘要

背景

经皮冠状动脉介入治疗(PCI)期间女性的首选抗凝剂尚未明确。

方法

进行电子检索,查找将接受PCI的患者随机分为比伐卢定组与肝素组,并报告女性相关感兴趣结局的试验。计算随机效应DerSimonian-Laird风险比(RR)。主要结局为30天时的净不良临床事件(NACE)。其他结局包括主要不良心脏事件(MACE)、全因死亡率、心肌梗死(MI)、靶血管血运重建(TVR)以及30天时的大出血。还检查了1年时的全因死亡率和MACE。

结果

纳入了9项将接受PCI的女性随机分为比伐卢定组(n = 3960)与肝素组(n = 4050)的试验。在30天时,与肝素相比,比伐卢定与NACE风险降低相关(RR = 0.85;95%CI 0.73 - 0.98;p = 0.03),主要是由于大出血减少(RR = 0.59;95%CI 0.49 - 0.71;p < 0.001)。两组之间在MACE(p = 0.92)、全因死亡率(p = 0.23)、MI(p = 0.86)或TVR(p = 0.53)方面未显示出差异。在1年时,两组的MACE和全因死亡率风险相似。在亚组分析中,当糖蛋白IIb/IIIa抑制剂(GPI)与肝素联合用作补救治疗时,比伐卢定的益处似乎不太明显,然而无显著交互作用。此外,在ST段抬高型心肌梗死(STEMI)人群中,两组之间在NACE、MACE或大出血方面未观察到差异。

结论

在接受PCI的女性中,与肝素相比,比伐卢定与大出血和NACE风险降低相关,尤其是在常规使用GPI时。

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