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吲哚布芬与阿司匹林用于老年急性冠状动脉综合征患者经皮冠状动脉介入治疗后的比较

Indobufen versus aspirin after percutaneous coronary intervention in elderly patients with acute coronary syndrome.

作者信息

Dai Wenbo, Mu Guanyu, Ren Jiayi, Hu Sutao, Guo Rongxin, Gu Tian-Shu, Che Jingjin, Ma Xianghong, Liu Tong, Wu Xue, Zhang Jing-Kun, Tse Gary, Wang Yajie, Zhou Jian-Mei, Rha Seung-Woon, Chen Kangyin

机构信息

Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, No. 23 Pingjiang Road, Hexi District, Tianjin, 300211, People's Republic of China.

Institute for Global Health Sciences, University of California, San Francisco, CA, USA.

出版信息

BMC Cardiovasc Disord. 2025 Jul 7;25(1):495. doi: 10.1186/s12872-025-04843-0.

Abstract

BACKGROUND

Antiplatelet therapy is pivotal in managing elderly patients with Acute Coronary Syndrome (ACS) following Percutaneous Coronary Intervention (PCI). While aspirin remains a cornerstone of this therapy, its use is sometimes limited by the risk of gastrointestinal (GI) complications or allergic reactions in certain patients.

PURPOSE

This study aims to assess the safety and efficacy of Indobufen as an alternative to aspirin when used in combination with clopidogrel in elderly ACS patients post-PCI.

METHODS

This is a single-center, retrospective study employing propensity score matching. Elderly ACS patients who underwent PCI between January 2019 and May 2022 were enrolled. Participant were categorized into two groups based on their medication regimen: the aspirin DAPT group and the indobufen DAPT group. The primary endpoint was the Net Adverse Clinical Event (NACE) at 1 year, which included all-cause mortality, stroke, myocardial infarction (MI), target lesion revascularisation, and bleeding events classified under the Bleeding Academic Research Consortium (BARC) criteria type 2, 3, or 5.

RESULTS

A total of 2087 patients were enrolled in this study. Based on their medication regimen, 348 patients were assigned to indobufen DAPT group, while 1739 individuals were assigned to aspirin DAPT group. After applying 1:1 propensity score matching, 306 patients were included in each group. During the 1-year follow-up, the NACE occurred in 59 patients (19.9%) of the Indobufen DAPT group and 58 patients (18.6%) in the aspirin DAPT group, with no significant difference between the groups (HR 1.029, 95% CI 0.714-1.484, P = 0.876). Additionally, there were no significant difference in Patient-Oriented Composite Endpoint (POCE) and BARC 2, 3, or 5 bleeding events between the groups at 1, 3, or 6 months of follow-up. However, the indobufen DAPT group experienced a lower incidence of upper GI symptoms compared to the aspirin DAPT group.

CONCLUSION

Indobufen, as an alternative to aspirin, demonstrates comparable efficacy and safety in elderly ACS patients after PCI, with a potential reduction in gastrointestinal symptoms. These findings support the use of indobufen as a viable alternative for elderly ACS patients who are intolerant to aspirin.

CLINICAL TRIAL NUMBER

Not applicable.

摘要

背景

抗血小板治疗在经皮冠状动脉介入治疗(PCI)后老年急性冠状动脉综合征(ACS)患者的管理中至关重要。虽然阿司匹林仍然是这种治疗的基石,但其使用有时会受到某些患者胃肠道(GI)并发症或过敏反应风险的限制。

目的

本研究旨在评估吲哚布芬在老年PCI术后ACS患者中与氯吡格雷联合使用时作为阿司匹林替代品的安全性和有效性。

方法

这是一项采用倾向评分匹配的单中心回顾性研究。纳入2019年1月至2022年5月期间接受PCI的老年ACS患者。根据用药方案将参与者分为两组:阿司匹林双联抗血小板治疗(DAPT)组和吲哚布芬DAPT组。主要终点是1年时的净不良临床事件(NACE),包括全因死亡率、中风、心肌梗死(MI)、靶病变血运重建以及根据出血学术研究联盟(BARC)标准分类为2、3或5型的出血事件。

结果

本研究共纳入2087例患者。根据用药方案,348例患者被分配到吲哚布芬DAPT组,1739例患者被分配到阿司匹林DAPT组。应用1:1倾向评分匹配后,每组纳入306例患者。在1年的随访期间,吲哚布芬DAPT组有59例患者(19.9%)发生NACE,阿司匹林DAPT组有58例患者(18.6%)发生NACE,两组之间无显著差异(风险比1.029,95%置信区间0.714 - 1.484,P = 0.876)。此外,在随访1、3或6个月时,两组在以患者为导向的复合终点(POCE)和BARC 2、3或5型出血事件方面也无显著差异。然而,吲哚布芬DAPT组上消化道症状的发生率低于阿司匹林DAPT组。

结论

吲哚布芬作为阿司匹林的替代品,在老年PCI术后ACS患者中显示出相当的疗效和安全性,且胃肠道症状可能减少。这些发现支持将吲哚布芬作为对阿司匹林不耐受的老年ACS患者的可行替代药物。

临床试验编号

不适用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0305/12232649/7575c167af4b/12872_2025_4843_Fig1_HTML.jpg

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