急性轻度至中度缺血性卒中患者的早期神经功能恶化与开始双联抗血小板疗法的时间：ATAMIS试验的预设事后分析。

IF 6 1区医学 Q1 CLINICAL NEUROLOGY Journal of Stroke Pub Date : 2024-09-01 Epub Date: 2024-09-30 DOI:10.5853/jos.2024.02250

Yu Cui, Zhi-Guo Yao, Jian Zhang, Hui-Sheng Chen

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引用次数: 0

摘要

背景和目的：本研究是对急性轻度至中度缺血性卒中抗血小板疗法（ATAMIS）试验进行的一项事后分析，旨在确定双重抗血小板疗法与单一疗法相比，在预防早期神经功能恶化（END）方面的效果是否因卒中发生至抗血小板疗法（OTT）的时间而有所不同：在 ATAMIS 试验中，患者被分为两个亚组：方法：在 ATAMIS 试验中，患者被分为两个亚组：0 至 24 小时的 OTT 组（0-24 小时组）和 24 至 48 小时的 OTT 组（24-48 小时组）。我们对连续OTT和分类OTT进行了多变量回归分析，以检测抗血小板治疗的效果。主要结果是7天后的END，即美国国立卫生研究院卒中量表（NIHSS）评分与基线相比增加两分以上。安全性结果为90天内的出血事件和颅内出血：共纳入 2,915 名患者。在7天的END方面，氯吡格雷联合阿司匹林在连续OTT中的比例低于单用阿司匹林（4.8% vs. 6.7%；调整后风险差异，-1.9%；95%置信区间[CI]，-3.6%至-0.2%；P=0.03），在0-24小时组中更低（5.7% vs. 9.2%；调整后风险差异，-3.7%；95%置信区间，-5.5%至-2.0%；PC结论：对于急性轻度至中度缺血性卒中患者，如果在症状出现 24 小时内开始服用氯吡格雷加阿司匹林，7 天后END 的风险低于单独服用阿司匹林。

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Early Neurological Deterioration and Time to Start Dual Antiplatelet Therapy in Patients With Acute Mild-to-Moderate Ischemic Stroke: A Pre-Specified Post Hoc Analysis of the ATAMIS Trial.

Background and purpose: This study comprised a post hoc analysis of the Antiplatelet Therapy in Acute Mild to Moderate Ischemic Stroke (ATAMIS) trial aiming to determine whether the effect of dual antiplatelet therapy compared with that of monotherapy on preventing early neurological deterioration (END) differed according to the time from stroke onset to antiplatelet therapy (OTT).

Methods: In the ATAMIS trial, patients were divided into two subgroups: OTT from 0 to 24 hours (0-24 h group) and OTT from 24 to 48 hours (24-48 h group). We conducted multivariate regression analysis with continuous and categorical OTT to detect the effect of antiplatelet therapy. The primary outcome was END at 7 days, defined as an increase in the National Institutes of Health Stroke Scale (NIHSS) score of more than two points compared with the baseline. The safety outcomes were bleeding events and intracranial hemorrhage within 90 days.

Results: A total of 2,915 patients were included. With respect to END at 7 days, clopidogrel plus aspirin showed a lower proportion than aspirin alone across continuous OTT (4.8% vs. 6.7%; adjusted risk difference, -1.9%; 95% confidence interval [CI], -3.6% to -0.2%; P=0.03), and was lower in the 0-24 hours group (5.7% vs. 9.2%; adjusted risk difference, -3.7%; 95% CI, -5.5% to -2.0%; P<0.01), but similar in the 24-48 hours group (3.5% vs. 2.9%; adjusted risk difference, 0.6%; 95% CI, -0.8% to 2.0%; P=0.40). We identified a significant interaction between the treatment effect and time subgroup with respect to the primary outcome (P=0.03). The occurrence of bleeding events and intracranial hemorrhage was similar in the time subgroup.

Conclusion: For patients with acute mild-to-moderate ischemic stroke, clopidogrel plus aspirin was associated with a lower risk of END at 7 days than aspirin alone when it was started within 24 hours of symptom onset.

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来源期刊

Journal of Stroke CLINICAL NEUROLOGYPERIPHERAL VASCULAR DISE-PERIPHERAL VASCULAR DISEASE

CiteScore

11.00

自引率

3.70%

发文量

审稿时长

12 weeks

期刊介绍： The Journal of Stroke (JoS) is a peer-reviewed publication that focuses on clinical and basic investigation of cerebral circulation and associated diseases in stroke-related fields. Its aim is to enhance patient management, education, clinical or experimental research, and professionalism. The journal covers various areas of stroke research, including pathophysiology, risk factors, symptomatology, imaging, treatment, and rehabilitation. Basic science research is included when it provides clinically relevant information. The JoS is particularly interested in studies that highlight characteristics of stroke in the Asian population, as they are underrepresented in the literature. The JoS had an impact factor of 8.2 in 2022 and aims to provide high-quality research papers to readers while maintaining a strong reputation. It is published three times a year, on the last day of January, May, and September. The online version of the journal is considered the main version as it includes all available content. Supplementary issues are occasionally published. The journal is indexed in various databases, including SCI(E), Pubmed, PubMed Central, Scopus, KoreaMed, Komci, Synapse, Science Central, Google Scholar, and DOI/Crossref. It is also the official journal of the Korean Stroke Society since 1999, with the abbreviated title J Stroke.