Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Australia.
Sticht Center for Healthy Aging and Alzheimer's Prevention, Department of Internal Medicine, Section on Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
JAMA Netw Open. 2023 Jul 3;6(7):e2325803. doi: 10.1001/jamanetworkopen.2023.25803.
IMPORTANCE: Low-dose aspirin has been widely used for primary and secondary prevention of stroke. The balance between potential reduction of ischemic stroke events and increased intracranial bleeding has not been established in older individuals. OBJECTIVE: To establish the risks of ischemic stroke and intracranial bleeding among healthy older people receiving daily low-dose aspirin. DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) randomized, double-blind, placebo-controlled trial of daily low-dose aspirin was conducted among community-dwelling people living in Australia or the US. Participants were older adults free of symptomatic cardiovascular disease. Recruitment took place between 2010 and 2014, and participants were followed up for a median (IQR) of 4.7 (3.6-5.7) years. This analysis was completed from August 2021 to March 2023. INTERVENTIONS: Daily 100-mg enteric-coated aspirin or matching placebo. MAIN OUTCOMES AND MEASURES: Stroke and stroke etiology were predetermined secondary outcomes and are presented with a focus on prevention of initial stroke or intracranial bleeding event. Outcomes were assessed by review of medical records. RESULTS: Among 19 114 older adults (10 782 females [56.4%]; median [IQR] age, 74 [71.6-77.7] years), 9525 individuals received aspirin and 9589 individuals received placebo. Aspirin did not produce a statistically significant reduction in the incidence of ischemic stroke (hazard ratio [HR], 0.89; 95% CI, 0.71-1.11). However, a statistically significant increase in intracranial bleeding was observed among individuals assigned to aspirin (108 individuals [1.1%]) compared with those receiving placebo (79 individuals [0.8%]; HR, 1.38; 95% CI, 1.03-1.84). This occurred by an increase in a combination of subdural, extradural, and subarachnoid bleeding with aspirin compared with placebo (59 individuals [0.6%] vs 41 individuals [0.4%]; HR, 1.45; 95% CI, 0.98-2.16). Hemorrhagic stroke was recorded in 49 individuals (0.5%) assigned to aspirin compared with 37 individuals (0.4%) in the placebo group (HR, 1.33; 95% CI, 0.87-2.04). CONCLUSIONS AND RELEVANCE: This study found a significant increase in intracranial bleeding with daily low-dose aspirin but no significant reduction of ischemic stroke. These findings may have particular relevance to older individuals prone to developing intracranial bleeding after head trauma. TRIAL REGISTRATION: ISRCTN.org Identifier: ISRCTN83772183.
重要性：小剂量阿司匹林已广泛用于中风的一级和二级预防。在老年人中，尚未确定潜在的缺血性中风事件减少与颅内出血增加之间的平衡。
目的：确定接受每日低剂量阿司匹林的健康老年人中缺血性中风和颅内出血的风险。
设计、地点和参与者：这是阿司匹林减少老年人事件（ASPREE）随机、双盲、安慰剂对照试验的二次分析，该试验在澳大利亚或美国的社区居住者中进行。参与者为无症状心血管疾病的老年人。招募工作于 2010 年至 2014 年进行，参与者的中位（IQR）随访时间为 4.7（3.6-5.7）年。这项分析于 2021 年 8 月至 2023 年 3 月完成。
干预措施：每日 100mg 肠溶阿司匹林或匹配的安慰剂。
主要结果和测量：中风和中风病因是预先确定的次要结果，并重点关注预防初始中风或颅内出血事件。结果通过审查病历进行评估。
结果：在 19114 名老年人（10782 名女性[56.4%]；中位数[IQR]年龄，74[71.6-77.7]岁）中，9525 名接受阿司匹林治疗，9589 名接受安慰剂治疗。阿司匹林并未显著降低缺血性中风的发生率（风险比[HR]，0.89；95%置信区间，0.71-1.11）。然而，与安慰剂组（79 例[0.8%]）相比，接受阿司匹林治疗的患者颅内出血发生率显著升高（108 例[1.1%]；HR，1.38；95%置信区间，1.03-1.84）。这是由于与安慰剂相比，阿司匹林组硬膜下、硬膜外和蛛网膜下腔出血的组合增加（59 例[0.6%]与 41 例[0.4%]；HR，1.45；95%置信区间，0.98-2.16）。与安慰剂组（49 例[0.5%]）相比，阿司匹林组记录到 49 例（0.5%）出血性中风（HR，1.33；95%置信区间，0.87-2.04）。
结论和相关性：本研究发现每日低剂量阿司匹林可显著增加颅内出血，但缺血性中风无显著减少。这些发现可能与易发生颅内出血的老年人在头部外伤后颅内出血的风险增加有关。
试验注册：ISRCTN.org 标识符：ISRCTN83772183。
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