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比伐芦定与肝素治疗急性冠状动脉综合征患者的疗效及安全性:一项系统评价和荟萃分析。

The efficacy and safety of bivalirudin and heparin in patients with acute coronary syndrome: a systematic review and meta-analysis.

作者信息

Zhai You, Shang Hongcai, Li Yan, Zhang Nan, Zhang Jisi, Wu Shangwen

机构信息

Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Haiyuncang Lane 5, Dongcheng District, Beijing, 100700, China.

Henan University of Chinese Medicine, No. 156 Jinshui Road, Zhengzhou, Henan, 450046, China.

出版信息

Syst Rev. 2025 Feb 10;14(1):39. doi: 10.1186/s13643-025-02782-7.

Abstract

BACKGROUND

Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) are at high risk of thrombosis. However, bleeding-related complications during antithrombotic therapy remain a major barrier to effective treatment and can often lead to adverse outcomes. This meta-analysis aimed to determine the efficacy and safety of bivalirudin and heparin in patients with ACS after PCI.

METHODS

Randomized controlled trials (RCTs) on the efficacy and safety of bivalirudin versus heparin in patients with ACS after PCI were identified from the PubMed, Embase, Cochrane Library, CBM, CNKI, WanFang, and VIP database until August 2024. The outcomes included all-cause mortality, major adverse cardiovascular events (MACEs), incidence of recurrent myocardial infarction, stent thrombosis, short-term bleeding, revascularization, and retransfusion. Meta-analysis was performed using RevMan 5.3 and Stata 12.0 softwares. The included studies were assessed for risk of bias using the Cochrane risk-of-bias assessment tool.

RESULTS

A total of 70,199 patients from 27 randomized controlled trials (RCTs) were analyzed in this review. There were no significant differences between the bivalirudin and heparin groups in terms of all-cause mortality, major adverse cardiovascular events (MACEs), recurrent myocardial infarction, stent thrombosis within 30 days, or subacute stent thrombosis. Specifically, the incidence of short-term bleeding (P = 0.001) and retransfusion (P = 0.001) was significantly lower in the bivalirudin group compared to the heparin group. Conversely, the incidence of acute stent thrombosis (P < 0.0001) and revascularization (P = 0.009) was significantly higher in the bivalirudin group.

CONCLUSIONS

Compared with heparin, bivalirudin has definite anticoagulant effect in patients with acute myocardial infarction after PCI, and the risk of bleeding and the incidence of retransfusion were lower in the bivalirudin group. This review helps doctors in PCI management choose bivalirudin or heparin more precisely based on patients' conditions for better treatment and fewer adverse events.

摘要

背景

接受经皮冠状动脉介入治疗(PCI)的急性冠状动脉综合征(ACS)患者存在血栓形成的高风险。然而,抗栓治疗期间与出血相关的并发症仍然是有效治疗的主要障碍,并且常常导致不良后果。本荟萃分析旨在确定比伐卢定和肝素在PCI术后ACS患者中的疗效和安全性。

方法

从PubMed、Embase、Cochrane图书馆、中国生物医学文献数据库(CBM)、中国知网(CNKI)、万方和维普数据库中检索截至2024年8月关于比伐卢定与肝素在PCI术后ACS患者中的疗效和安全性的随机对照试验(RCT)。结局指标包括全因死亡率、主要不良心血管事件(MACE)、心肌梗死复发率、支架内血栓形成、短期出血、血运重建和再次输血。使用RevMan 5.3和Stata 12.0软件进行荟萃分析。采用Cochrane偏倚风险评估工具对纳入研究的偏倚风险进行评估。

结果

本综述共分析了来自27项随机对照试验(RCT)的70199例患者。比伐卢定组和肝素组在全因死亡率、主要不良心血管事件(MACE)、心肌梗死复发、30天内支架内血栓形成或亚急性支架内血栓形成方面无显著差异。具体而言,比伐卢定组的短期出血发生率(P = 0.001)和再次输血发生率(P = 0.001)显著低于肝素组。相反,比伐卢定组的急性支架内血栓形成发生率(P < 0.0001)和血运重建发生率(P = 0.009)显著更高。

结论

与肝素相比,比伐卢定在PCI术后急性心肌梗死患者中具有确切的抗凝作用,且比伐卢定组的出血风险和再次输血发生率较低。本综述有助于PCI治疗中的医生根据患者情况更精确地选择比伐卢定或肝素,以实现更好的治疗效果并减少不良事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b649/11808951/0ef1f287ee1c/13643_2025_2782_Fig1_HTML.jpg

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