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Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled
Suzanne E Mahady1,2, Karen L Margolis3, Andrew Chan4
1School of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia suzanne.mahady@monash.edu.
Insights
Low-dose aspirin increases gastrointestinal bleeding risk by 60% in older adults. However, the absolute 5-year risk of serious bleeding remains modest for younger, healthier individuals, aiding informed aspirin use decisions.
Area of Science:
- Gerontology
- Gastroenterology
- Clinical Pharmacology
Background:
- Significant gastrointestinal bleeding data in older adults using aspirin is limited.
- Aspirin's prophylactic use in primary prevention requires careful risk-benefit assessment, especially in the elderly.
Purpose of the Study:
- To determine the incidence, risk factors, and absolute risk of major gastrointestinal bleeding in elderly individuals receiving aspirin for primary prevention.
- To provide data for informed decision-making regarding prophylactic aspirin use in older populations.
Main Methods:
- Utilized data from the ASPirin in Reducing Events in the Elderly (ASPREE) randomized controlled trial (n=19,114) involving community-dwelling individuals aged 70 years and older.
- Major gastrointestinal bleeding was defined as events requiring transfusion, hospitalization, surgery, or death, and independently adjudicated.
- Follow-up occurred over a median of 4.7 years, with clinical characteristics collected at baseline and annually.
Main Results:
- Aspirin use was associated with a 60% increase in overall gastrointestinal bleeding risk (Hazard Ratio 1.87 for upper GI bleeds, p<0.01).
- Multivariable analyses identified age, smoking, hypertension, chronic kidney disease, and obesity as risk factors for increased bleeding.
- The absolute 5-year risk of bleeding ranged from 0.25% in a 70-year-old not on aspirin to 5.03% in an 80-year-old on aspirin with additional risk factors.
Conclusions:
- Aspirin significantly increases overall gastrointestinal bleeding risk in older adults.
- Despite the increased relative risk, the absolute 5-year risk of serious bleeding is modest in younger, healthier elderly individuals.
- These findings support shared decision-making between patients and clinicians regarding the prophylactic use of aspirin.
Objective:
There is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.
Design:
Data were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010-2017 ('ASPirin in Reducing Events in the Elderly (ASPREE)', n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.
Results:
Over a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.
Conclusion:
Aspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.
Trial Registration Number:
ASPREE. NCT01038583.
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