Daily low-dose ASA increases intracranial bleeding risk by 38% in healthy older adults

A secondary analysis of the Aspirin in Reducing Events in the Elderly (ASPREE) trial has provided valuable information about the occurrence of ischemic stroke and intracranial bleeding among healthy older adults receiving long-term daily low-dose acetylsalicylic acid (ASA).1 The randomized, double-blind, placebo-controlled trial included community-dwelling older adults living in Australia or the United States, who were relatively healthy and free of symptomatic cardiovascular disease or cerebrovascular disease. Patients were randomized to receive enteric-coated ASA 100 mg daily or matching placebo. Study participants were followed up for a median of 4.7 years.1 Stroke occurrence and stroke etiology were the main study outcomes.1 Results showed the following: The study included 19,114 older adults (56.4% female; median age, 74 years); 9,525 individuals received ASA and 9,589 individuals received placebo. ASA did not produce a statistically significant reduction in the incidence of ischemic stroke (hazard ratio [HR], 0.89; 95% CI, 0.71–1.11). A statistically significant increase in intracranial bleeding was seen in individuals receiving ASA (108 individuals [1.1%]) compared with those receiving placebo (79 individuals [0.8%]; HR, 1.38; 95% CI, 1.03–1.84). The observed increase in intracranial bleeding was related to an increase in a combination of subdural, extradural and subarachnoid bleeding with ASA compared with placebo (59 individuals [0.6%] vs 41 individuals [0.4%]; HR, 1.45; 95% CI, 0.98–2.16). Hemorrhagic stroke occurred in 49 individuals (0.5%) in the ASA group compared with 37 individuals (0.4%) in the placebo group (HR, 1.33; 95% CI, 0.87–2.04).1 The authors conclude that in this clinical trial of healthy older adults, daily low-dose ASA resulted in a significant increase in intracranial bleeding, but had no significant benefit in preventing stroke.1 These data support recent recommendations not to routinely initiate low-dose ASA for primary prevention of cardiovascular disease in healthy older adults.2,3 The authors point out that their findings may be particularly relevant to older individuals prone to developing intracranial bleeding after head trauma (e.g., after a fall or other accident). Intracranial hemorrhage is typically less treatable than an ischemic event and more frequently fatal or disabling. Their results also suggest caution regarding the inclusion of ASA in a “polypill” to prevent cardiovascular disease.1 References 1. Cloud GC, Williamson JD, Thao LTP, et al. Low-dose aspirin and the risk of stroke and intracerebral bleeding in healthy older people. Secondary analysis of a randomized clinical trial. JAMA Network Open 2023;6(7):e2325803. (accessed July 27, 2023). 2. US Preventive Services Task Force. US Preventive Services Task Force recommendation statement. Aspirin use to prevent cardiovascular disease, April 26, 2022. JAMA 2022;327:1577-84.(accessed July 27, 2023). 3. Prinsloo M. Geriatric Issues. Is low-dose ASA a good choice for all older adults? Canadian Healthcare Network; December 4, 2022. (accessed July 27, 2023).

Daily low-dose ASA increases intracranial bleeding risk by 38% in healthy older adults

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