Episode 391: 402. Functional disability after clinically significant extracranial bleeding: a secondary analysis of ASPREE

https://www.jthjournal.org/article/S1538-7836(25)00109-6/fulltext
Antithrombotic agents, like aspirin and anticoagulants, are essential for treating many cardiovascular conditions. However, a common side effect is bleeding, with extracranial bleeding—bleeding outside the brain and spinal cord—being quite prevalent. This study, a secondary analysis of the Aspirin in Reducing Events in the Elderly, or ASPREE trial, aimed to explore how clinically significant extracranial bleeding affects the development of functional disability in otherwise healthy older adults.

What did the researchers find?

Summary of Findings:

• Incidence of Bleeding: Out of nearly 19,000 participants, about 2.9%, or 547 individuals, experienced clinically significant extracranial bleeding.
• Functional Independence Impact: Those who experienced such bleeding had a more than two-fold increase in the risk of developing dependence on activities of daily living, or ADLs. Specifically, the hazard ratio for ADL dependence was 2.46, indicating a significant association.
• Types of Bleeding: Both gastrointestinal (GI) bleeding and other non-GI extracranial bleeding showed similar risks, with hazard ratios of 2.29 and 2.68 respectively. Importantly, these associations held true whether participants were on aspirin or a placebo.

Strengths of the Study:

1. Large Sample Size: With nearly 19,000 participants, the study provides robust data.
2. Rigorous Data Collection: Bleeding events were meticulously documented and adjudicated by medical professionals.
3. Comprehensive Analysis: The detailed follow-up and frequent assessments allowed for thorough monitoring of participants' health outcomes over several years.

Weaknesses of the Study:

1. Granular Data Absence: Specific details about hospitalization, such as length of stay or the number of transfusions, were not available.
2. Data Collection Frequency: Bleeding events were assessed continuously, whereas ADL dependence was assessed biannually. This discrepancy could lead to challenges in pinpointing the exact onset of functional dependence relative to bleeding events.