比伐卢定与肝素在急性冠脉综合征患者经皮冠状动脉介入治疗中的比较：一项荟萃分析。
完整摘要 · 中文译文
背景：比伐芦定和肝素是急性冠脉综合征（ACS）患者接受经皮冠状动脉介入治疗（PCI）时常用的抗凝药物。本荟萃分析旨在比较比伐芦定与肝素在接受 PCI 的 ACS 患者中的安全性和有效性。 方法：我们系统检索了 PubMed、Embase、Web of Science 和 Cochrane 图书馆，纳入比较比伐芦定与肝素在接受 PCI 的 ACS 患者中应用的随机对照试验（RCT）和队列研究。结局指标包括全因死亡率、心血管死亡率、大出血、主要不良心血管事件（MACEs）、净不良临床事件、心肌梗死（MI）、支架内血栓形成（ST）和卒中。 结果：本研究纳入 11 项 RCT 和 17 项队列研究，共涵盖 584,249 例患者。在院内结局中，与肝素相比，比伐芦定显著降低全因死亡率（相对风险 [RR] = 0.86，95% 置信区间 [CI]：0.84–0.88，P < .001，I² = 0%）和大出血发生率（RR = 0.74，95% CI：0.62–0.88，P < .001，I² = 51%），而 MACEs、MI、ST 和卒中的发生率无显著差异。在 30 天随访结局中，比伐芦定显著降低全因死亡率（RR = 0.85，95% CI：0.76–0.95，P = .006，I² = 24%）、心血管死亡率（RR = 0.81，95% CI：0.70–0.94，P = .004，I² = 1%）、大出血发生率（RR = 0.59，95% CI：0.49–0.72，P < .001，I² = 67%）和净不良临床事件发生率（RR = 0.79，95% CI：0.70–0.89，P < .001，I² = 55%）——与肝素相比。 与肝素相比，而在主要不良心血管事件、心肌梗死、支架内血栓形成和卒中方面无显著差异。 结论：这项荟萃分析提示，在接受经皮冠状动脉介入治疗的急性冠脉综合征患者中，比伐卢定在降低院内和30天死亡率及大出血方面可能优于肝素，而在主要不良心血管事件、心肌梗死、支架内血栓形成或卒中等缺血性结局方面无显著差异。这些发现提示，在特定患者中比伐卢定可能是肝素的合理替代选择，但需要更多大规模、长期随机对照试验来证实这些结果。
完整摘要 · 英文原文
BACKGROUND: Bivalirudin and heparin are commonly employed anticoagulants in percutaneous coronary intervention (PCI) for patients diagnosed with acute coronary syndrome (ACS). This meta-analysis aimed to compare the safety and efficacy of bivalirudin and heparin in patients with ACS undergoing PCI. METHODS: We systematically searched PubMed, Embase, Web of Science, and the Cochrane Library for randomized controlled trials (RCTs) and cohort studies comparing bivalirudin with heparin in patients with ACS undergoing PCI. The outcomes included all-cause mortality, cardiovascular mortality, major bleeding, major adverse cardiovascular events (MACEs), net adverse clinical events, myocardial infarction (MI), stent thrombosis (ST), and stroke. RESULTS: This study included 11 RCTs and 17 cohort studies, encompassing 584,249 patients. Among in-hospital outcomes, bivalirudin was found to significantly reduce the incidence of all-cause mortality (relative risk [RR] = 0.86, 95% confidence interval [CI]: 0.84-0.88, P < .001, I2 = 0%) and major bleeding (RR = 0.74, 95% CI: 0.62-0.88, P < .001, I2 = 51%) compared with heparin, while there were no significant differences in MACEs, MI, ST, and stroke. Among 30-day follow-up outcomes, bivalirudin was found to significantly reduce the incidence of all-cause mortality (RR = 0.85, 95% CI: 0.76-0.95, P = .006, I2 = 24%), cardiovascular mortality (RR = 0.81, 95% CI: 0.70-0.94, P = .004, I2 = 1%), major bleeding (RR = 0.59, 95% CI: 0.49-0.72, P < .001, I2 = 67%), and net adverse clinical events (RR = 0.79, 95% CI: 0.70-0.89, P < .001, I2 = 55%) compared with heparin, while there were no significant differences in MACEs, MI, ST, and stroke. CONCLUSION: This meta-analysis suggests that bivalirudin may offer advantages over heparin in reducing in-hospital and 30-day mortality and major bleeding in patients with ACS undergoing PCI, with no significant differences in ischemic outcomes such as MACEs, MI, ST, or stroke. These findings suggest that bivalirudin may be a reasonable alternative to heparin in selected patients, but more large-scale, long-term RCTs are needed to confirm these results.