目的:本荟萃分析的重点是研究在发生ST段抬高型心肌梗死(STEMI)并接受直接经皮冠状动脉介入治疗(PCI)的患者中,比伐卢定联合PCI后输注是否比肝素单药治疗更安全、更有效。
方法:PubMed,EMBASE,科克伦图书馆,系统检索了WebofScience数据库,以确定比较比伐卢定和肝素治疗接受原发性PCI的STEMI患者的随机对照试验(RCT).Cochrane质量评估工具用于评估纳入研究的质量。主要和次要结局包括净不良临床事件(NACEs,包括全因死亡或大出血),主要不良心血管事件(MACE,包括全因死亡,中风,MI,和TVR),支架内血栓形成(IST),和出血学术研究联盟(BARC)类型2,3和5。
结果:四个RCT,包括10,695个事件,包括5350例接受比伐卢定联合PCI后输注的患者和5345例接受肝素单药治疗的患者.与肝素组相比,NACE数(RR0.84,95%CI0.73-0.96,P=0.009),MACE(RR0.82,95%CI0.67-0.99,P=0.04),和ISTS(RR0.66,95%CI0.49-0.91,P<0.0001)在比伐卢定组中显著降低。全因死亡没有显著差异,心脏死亡,中风,MI,TVR,或BARC2、3或5型出血。
结论:在接受原发性PCI的STEMI患者中,比伐卢定联合PCI后输注可显著降低NACEs的发生率,MACEs,和ISTS与肝素单一疗法相比,不会增加MI或TVR的风险。比伐卢定也可能有助于中风的潜在减少,死亡,和BARC2、3和5型出血率。
OBJECTIVE: The present meta-analysis focused on investigating whether
bivalirudin plus post-PCI infusion was safer and more effective than heparin monotherapy in patients who developed ST-segment elevation myocardial infarction (STEMI) and who underwent primary percutaneous coronary intervention (PCI).
METHODS: The PubMed, EMBASE, Cochrane Library, and Web of Science databases were systemically searched to identify randomized controlled trials (RCTs) comparing
bivalirudin and heparin for treating STEMI patients who underwent primary PCI. The Cochrane quality assessment tool was used to assess the quality of the enrolled studies. The primary and secondary outcomes included net adverse clinical events (NACEs, comprising all-cause death or major bleeding), major adverse cardiovascular events (MACEs, comprising all-cause death, stroke, MI, and TVR), in-stent thrombosis (IST), and bleeding of Bleeding Academic Research Consortium (BARC) types 2, 3, and 5.
RESULTS: The four RCTs, comprising 10,695 events, included 5350 patients who received
bivalirudin combined with post-PCI infusion and 5345 patients who received heparin monotherapy. Compared with those in the heparin group, the number of NACEs (RR 0.84, 95% CI 0.73-0.96, P = 0.009), MACEs (RR 0.82, 95% CI 0.67-0.99, P = 0.04), and ISTs (RR 0.66, 95% CI 0.49-0.91, P < 0.0001) in the bivalirudin group was significantly lower. There were no significant differences in all-cause death, cardiac death, stroke, MI, TVR, or BARC type 2, 3, or 5 bleeding between the two groups.
CONCLUSIONS: In STEMI patients undergoing primary PCI,
bivalirudin plus post-PCI infusion significantly reduced the incidence of NACEs, MACEs, and ISTs compared with heparin monotherapy, without increasing the risk of MI or TVR.
Bivalirudin may also contribute to a potential reduction in stroke, death, and BARC type 2, 3, and 5 bleeding rates.