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比伐卢定与肝素对经皮冠状动脉介入治疗的老年中国患者的净不良临床事件、主要不良心脑血管事件和出血的影响。

Bivalirudin versus Heparin on Net Adverse Clinical Events, Major Adverse Cardiac and Cerebral Events, and Bleeding in Elderly Chinese Patients Treated with Percutaneous Coronary Intervention.

机构信息

Department of Pharmacy, The Affiliated Hospital, Southwest Medical University.

Department of Critical Care Medicine, The Affiliated Hospital, Southwest Medical University.

出版信息

Tohoku J Exp Med. 2024 Mar 6;262(2):115-124. doi: 10.1620/tjem.2023.J085. Epub 2023 Oct 12.

Abstract

Bivalirudin as an anticoagulant reduces bleeding after percutaneous coronary intervention (PCI), while its impact in elderly Chinese patients treated with PCI needs more evidence. This study aimed to compare the clinical outcomes between bivalirudin and heparin in elderly Chinese patients treated with PCI. This cohort study retrieved data of 1,286 elderly patients treated with PCI who used bivalirudin (bivalirudin group, N = 493) or heparin (heparin group, N = 793) as anticoagulants. Net adverse clinical events (NACEs) (primary endpoint), major adverse cardiac and cerebral events (MACCEs), bleeding, and major bleeding within 30 days after PCI treatment were recorded for analysis. Our study illustrated that NACEs (12.4% vs. 17.4%, P = 0.015), bleeding (6.7% vs. 12.1%, P = 0.002), and major bleeding (2.2% vs. 6.6%, P < 0.001) were fewer in bivalirudin group compared to heparin group. No difference was found in MACCEs (7.5% vs. 9.6%,P = 0.200), and incidences of all-cause mortality (P = 0.257), cardiac mortality (P = 0.504), recurrent myocardial infarction (P = 0.423), ischemia-driven revascularization (P = 0.509), and stroke (P = 0.467), between bivalirudin group and heparin group. According to univariate logistic regression analyses, bivalirudin (vs. heparin) correlated with fewer NACEs (P = 0.016), bleeding (P = 0.002), and major bleeding (P = 0.001) in elderly patients treated with PCI, but not MACCEs (P = 0.202). After adjustment, bivalirudin (vs. heparin) was an independent factor for fewer NACEs [odds ratio (OR): 0.619, P = 0.009], bleeding (OR: 0.499, P = 0.003), and major bleeding (OR: 0.342, P = 0.003) in these patients. In summary, bivalirudin achieves fewer NACEs, bleeding, and major bleeding, but not MACCEs, versus heparin in elderly patients treated with PCI, which is verified in the multivariate model.

摘要

比伐卢定作为抗凝剂可减少经皮冠状动脉介入治疗(PCI)后的出血,但其在接受 PCI 治疗的老年中国患者中的影响需要更多证据。本研究旨在比较比伐卢定和肝素在接受 PCI 治疗的老年中国患者中的临床结局。这项队列研究检索了 1286 名接受 PCI 治疗且使用比伐卢定(比伐卢定组,N=493)或肝素(肝素组,N=793)作为抗凝剂的老年患者的数据。记录了 30 天内的净不良临床事件(NACEs)(主要终点)、主要不良心脑血管事件(MACCEs)、出血和主要出血情况以进行分析。我们的研究表明,比伐卢定组的 NACEs(12.4%比 17.4%,P=0.015)、出血(6.7%比 12.1%,P=0.002)和主要出血(2.2%比 6.6%,P<0.001)均少于肝素组。两组 MACCEs(7.5%比 9.6%,P=0.200)、全因死亡率(P=0.257)、心源性死亡率(P=0.504)、复发性心肌梗死(P=0.423)、缺血驱动的血运重建(P=0.509)和卒中(P=0.467)发生率无差异。根据单因素逻辑回归分析,与肝素相比,比伐卢定(vs.肝素)与 PCI 治疗老年患者的 NACEs 减少(P=0.016)、出血(P=0.002)和主要出血(P=0.001)相关,但与 MACCEs 无关(P=0.202)。调整后,与肝素相比,比伐卢定(vs.肝素)是 PCI 治疗老年患者 NACEs [比值比(OR):0.619,P=0.009]、出血(OR:0.499,P=0.003)和主要出血(OR:0.342,P=0.003)减少的独立因素。总之,比伐卢定与肝素相比,在接受 PCI 治疗的老年患者中可减少 NACEs、出血和主要出血,但不减少 MACCEs,这在多变量模型中得到验证。

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