Maqsood M Haisum, Tamis-Holland Jacqueline E, Feit Frederick, Bangalore Sripal
Department of Cardiology, DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas, USA.
Cleveland Clinic, Heart, Vascular and Thoracic Institute, Cleveland, Ohio, USA.
Catheter Cardiovasc Interv. 2025 Jan;105(1):54-67. doi: 10.1002/ccd.31276. Epub 2024 Nov 6.
Randomized trials of bivalirudin in patients with ST elevation myocardial infarction (STEMI) have yielded heterogeneous results.
Our aim was to evaluate the efficacy and safety of four antithrombin regimens-unfractionated heparin (UFH), bivalirudin (stopped soon after percutaneous coronary intervention [PCI]), extended bivalirudin (continued for a few hours after PCI), and combined UFH and a Gp2b3a inhibitors (GPI) in patients who present with STEMI.
A PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials (RCTs) of the above antithrombin in patients with STEMI. The primary outcome was net adverse cardiovascular events (NACE). The primary ischemic endpoint was major adverse cardiovascular events (MACE), and the primary safety endpoint was major bleeding, and other endpoints included all-cause mortality and stent thrombosis. The primary analysis compared the effect of these antithrombin regimens in reference to UFH using a mixed treatment comparison meta-analysis.
In the 14 RCTs evaluating 25,415 patients with STEMI, when compared to UFH monotherapy, extended bivalirudin lowered NACE (OR = 0.71 with 95% CI: 0.53-0.96; moderate level of confidence) driven by a significant decrease in major bleeding (OR = 0.42 with 95% CI: 0.26-0.68; high level of confidence) without any significant difference in MACE or all-cause mortality. When compared with UFH monotherapy, UFH+GPI reduced risk of MACE (OR = 0.76 with 95% CI: 0.60-0.97; high level of confidence) but at the expense of an increase in major bleeding (OR = 1.48 with 95% CI: 1.11-1.98; high level of confidence) with no difference in NACE or all-cause mortality. For major bleeding, extended bivalirudin infusion ranked #1, bivalirudin ranked #2, UFH monotherapy ranked #3, and combined UFH and GPI ranked #4. For NACE, extended bivalirudin infusion ranked #1, bivalirudin ranked #2, combined UFH and GPI ranked #3, and UFH monotherapy ranked #4. Cluster plots for MACE and major bleeding demonstrated that extended bivalirudin had the best balance for efficacy and safety.
In patients undergoing PCI for STEMI, extended bivalirudin offers the best balance for primary ischemic (MACE) and safety (major bleeding) outcomes.
关于比伐卢定用于ST段抬高型心肌梗死（STEMI）患者的随机试验结果不一。
我们的目的是评估四种抗凝血酶方案——普通肝素（UFH）、比伐卢定（经皮冠状动脉介入治疗[PCI]后很快停用）、延长使用比伐卢定（PCI后持续使用数小时）以及联合使用UFH和糖蛋白IIb/IIIa抑制剂（GPI）——在STEMI患者中的疗效和安全性。
检索PubMed、EMBASE和clinicaltrials.gov数据库，查找上述抗凝血酶用于STEMI患者的随机临床试验（RCT）。主要结局是净不良心血管事件（NACE）。主要缺血终点是主要不良心血管事件（MACE），主要安全终点是大出血，其他终点包括全因死亡率和支架血栓形成。主要分析采用混合治疗比较荟萃分析，比较这些抗凝血酶方案相对于UFH的效果。
在评估25415例STEMI患者的14项RCT中，与UFH单药治疗相比，延长使用比伐卢定降低了NACE（比值比[OR]=0.71，95%置信区间[CI]：0.53 - 0.96；中等置信水平），这是由于大出血显著减少（OR=0.42，95%CI：0.26 - 0.68；高置信水平），而MACE或全因死亡率无显著差异。与UFH单药治疗相比，UFH + GPI降低了MACE风险（OR=0.76，95%CI：0.60 - 0.97；高置信水平），但代价是大出血增加（OR=1.48，95%CI：1.11 - 1.98；高置信水平），NACE或全因死亡率无差异。对于大出血，延长使用比伐卢定输注排名第1，比伐卢定排名第2，UFH单药治疗排名第3，联合使用UFH和GPI排名第4。对于NACE，延长使用比伐卢定输注排名第1，比伐卢定排名第2，联合使用UFH和GPI排名第3，UFH单药治疗排名第4。MACE和大出血的聚类图显示，延长使用比伐卢定在疗效和安全性方面具有最佳平衡。
在接受PCI治疗的STEMI患者中，延长使用比伐卢定在主要缺血（MACE）和安全性（大出血）结局方面提供了最佳平衡。
