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50毫克/天和100毫克/天阿司匹林用于中国老年人心血管疾病预防和管理的相关结局:一项多中心、前瞻性、观察性研究的单中心中期分析

Outcomes Associated with 50 mg/d and 100 mg/d Aspirin for the Prevention and Management of Cardiovascular Disease in Chinese Elderly: Single-Center Interim Analysis of a Multicenter, Prospective, Observational Study.

作者信息

Wang Xiting, Wang Hao, Zheng Qin, Geng Hui, Zhang Jing, Fan Yan, Feng Xueru, Chen Xiahuan, Liu Meilin

机构信息

Department of Geriatrics, Peking University First Hospital, Beijing, People's Republic of China.

出版信息

Int J Gen Med. 2022 Sep 6;15:7089-7100. doi: 10.2147/IJGM.S384375. eCollection 2022.

DOI:10.2147/IJGM.S384375
PMID:36097566
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9464038/
Abstract

PURPOSE

Although aspirin can effectively reduce the occurrence of atherothrombosis, it is significantly associated with increased bleeding, with elderly individuals being at increased risk of cardiovascular diseases (CVD) and hemorrhage. This study aims to evaluate the efficacy and safety of aspirin 50 mg/d and 100 mg/d for the prevention and management of CVD in Chinese elderly.

PATIENTS AND METHODS

The Low-dose Aspirin for Primary and Secondary Prevention of Cardiovascular Disease in the Elderly Study (LAPIS) is a multicenter, prospective, observational cohort study, this study was a single-center interim analysis of LAPIS. Patients aged ≥60 and required long-term aspirin for primary and secondary prevention of CVD were eligible. From Apr 1, 2019 to Feb 28, 2022, 165 patients who received 50 mg/d aspirin and 261 patients who received 100 mg/d aspirin were included in the study. The incidence of major cardiovascular events (MACEs), bleeding events, and gastrointestinal adverse events were compared between two groups.

RESULTS

After adjusting for patient characteristics using propensity score matching, aspirin 100 mg/d was associated with increased incidence rates of total bleeding events (28.34 vs.17.25 events/100 patient-years, HR 1.671, 95% CI 1.024-2.712, P = 0.040) and minor bleeding events (27.63 vs.15.92 events/100 patient-years, HR 1.738, 95% CI 1.056-2.861, P = 0.031), whereas the incidence of MACE (6.35 vs 6.65 events/100 patient-years, HR 0.921, 95% CI 0.399-2.127, P = 0.848) and gastrointestinal adverse events (12.73 vs.10.42 events/100 patient-years, HR 1.206, 95% CI 0.623-2.337, P = 0.578) were similar between the two groups. Multivariate Cox analysis identified that aspirin dose (100 mg/d vs. 50 mg/d, HR 1.918, 95% CI 1.137-3.235, P = 0.015), concomitant use of other antiplatelets (HR 1.748, 95% CI 1.009-3.028, P = 0.046) and anticoagulants (HR 2.501, 95% CI 1.287-4.862, P = 0.007) were independently associated with bleeding events.

CONCLUSION

50 mg/d aspirin may be preferred to balance the safety and effectiveness in Chinese individuals over 60 years of age who need long-term aspirin for the prevention and management of CVD.

TRIAL REGISTRATION

ChiCTR1900021980 (chictr.org.cn). Registered on 19 March 2019.

摘要

目的

尽管阿司匹林可有效降低动脉粥样硬化血栓形成的发生率,但它与出血风险增加显著相关,老年人患心血管疾病(CVD)和出血的风险更高。本研究旨在评估50mg/d和100mg/d阿司匹林在中国老年人群中预防和管理CVD的疗效和安全性。

患者与方法

老年人心血管疾病一级和二级预防低剂量阿司匹林研究(LAPIS)是一项多中心、前瞻性观察队列研究,本研究是LAPIS的单中心中期分析。年龄≥60岁且需要长期服用阿司匹林进行CVD一级和二级预防的患者符合入选标准。2019年4月1日至2022年2月28日,本研究纳入了165例接受50mg/d阿司匹林治疗的患者和261例接受100mg/d阿司匹林治疗的患者。比较两组主要心血管事件(MACE)、出血事件和胃肠道不良事件的发生率。

结果

采用倾向评分匹配法调整患者特征后,100mg/d阿司匹林组的总出血事件发生率(28.34对17.25事件/100患者年,HR 1.671,95%CI 1.024 - 2.712,P = 0.040)和轻微出血事件发生率(27.63对15.92事件/100患者年,HR 1.738,95%CI 1.056 - 2.861,P = 0.031)均有所增加,而两组的MACE发生率(6.35对6.65事件/100患者年,HR 0.921,95%CI 0.399 - 2.127,P = 0.848)和胃肠道不良事件发生率(12.73对10.42事件/100患者年,HR 1.206,95%CI 0.623 - 2.337,P = 0.578)相似。多因素Cox分析确定,阿司匹林剂量(100mg/d对50mg/d,HR 1.918,95%CI 1.137 - 3.235,P = 0.015)、同时使用其他抗血小板药物(HR 1.748,95%CI 1.009 - 3.028,P = 0.046)和抗凝剂(HR 2.501,95%CI 1.287 - 4.862,P = 0.007)与出血事件独立相关。

结论

对于60岁以上需要长期服用阿司匹林预防和管理CVD的中国人群,50mg/d阿司匹林可能更有利于平衡安全性和有效性。

试验注册

ChiCTR1900021980(chictr.org.cn)。于2019年3月19日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b71/9464038/a00a755f6549/IJGM-15-7089-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b71/9464038/60916575fc91/IJGM-15-7089-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b71/9464038/a00a755f6549/IJGM-15-7089-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b71/9464038/60916575fc91/IJGM-15-7089-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5b71/9464038/a00a755f6549/IJGM-15-7089-g0002.jpg

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