Abstract | Importance: Objective: 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.
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Authors | Geoffrey C Cloud, Jeff D Williamson, Le Thi Phuong Thao, Cammie Tran, Charles B Eaton, Rory Wolfe, Mark R Nelson, Christopher M Reid, Anne B Newman, Jessica Lockery, Sharyn M Fitzgerald, Anne M Murray, Raj C Shah, Robyn L Woods, Geoffrey A Donnan, John J McNeil |
Journal | JAMA network open
(JAMA Netw Open)
Vol. 6
Issue 7
Pg. e2325803
(07 03 2023)
ISSN: 2574-3805 [Electronic] United States |
PMID | 37494038
(Publication Type: Randomized Controlled Trial, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Platelet Aggregation Inhibitors
- Aspirin
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Topics |
- Female
- Humans
- Aged
- Platelet Aggregation Inhibitors
(adverse effects)
- Aspirin
(adverse effects)
- Stroke
(epidemiology, prevention & control, drug therapy)
- Cerebral Hemorrhage
(chemically induced, epidemiology, prevention & control)
- Intracranial Hemorrhages
(chemically induced, epidemiology, prevention & control)
- Ischemic Stroke
(drug therapy)
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