Sun Bing, Chen Rui Rui
Department of Cardiology, Tang Du Hospital, Air Force Medical University, Shaanxi, China.
Cardiovasc Drugs Ther. 2024 Jul 30. doi: 10.1007/s10557-024-07609-6.
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).
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.
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.
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.
本荟萃分析旨在研究在发生ST段抬高型心肌梗死（STEMI）且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术后输注是否比肝素单药治疗更安全、更有效。
系统检索PubMed、EMBASE、Cochrane图书馆和Web of Science数据库，以识别比较比伐卢定和肝素治疗接受直接PCI的STEMI患者的随机对照试验（RCT）。使用Cochrane质量评估工具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（NACE，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、心肌梗死和靶血管重建）、支架内血栓形成（IST）以及出血学术研究联盟（BARC）2、3和5型出血。
四项RCT共纳入10695例患者，其中5350例接受比伐卢定联合PCI术后输注，5345例接受肝素单药治疗。与肝素组相比，比伐卢定组的NACE（风险比[RR]0.84，95%置信区间[CI]0.73 - 0.96，P = 0.009）、MACE（RR 0.82，95% CI 0.67 - 0.99，P = 0.04）和IST（RR 0.66，95% CI 0.49 - 0.91，P < 0.0001）数量显著更低。两组在全因死亡、心源性死亡、中风、心肌梗死、靶血管重建或BARC 2、3或5型出血方面无显著差异。
在接受直接PCI的STEMI患者中，与肝素单药治疗相比，比伐卢定联合PCI术后输注显著降低了NACE、MACE和IST的发生率，且未增加心肌梗死或靶血管重建的风险。比伐卢定还可能有助于潜在降低中风、死亡以及BARC 2、3和5型出血率。
