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Mahady SE, Margolis KL, Chan A, et al. Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial. Gut. 2020 Aug 3. pii: gutjnl-2020-321585. doi: 10.1136/gutjnl-2020-321585. (Original study)

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.


Discipline Area Score
Family Medicine (FM)/General Practice (GP) 6 / 7
General Internal Medicine-Primary Care(US) 6 / 7
Hemostasis and Thrombosis 6 / 7
Geriatrics 6 / 7
Public Health 6 / 7
Comments from MORE raters

Geriatrics rater

Very nice to have some (reasonably) solid numbers to begin a conversation with patients.

Geriatrics rater

Using data from the ASPREE trial, this study quantities the 5-year risk for GI bleeding associated with 100 mg daily of ASA for primary prevention of CVD in adults = age 70. These results support previous research (Lancet 2017; 390:490) regarding the age-related increase in GI bleeding associated with ASA. Mahady et al demonstrate that the 5-yr risk of GI bleeding increases up to two-fold with ASA use at age 70 , but increases up to 10-fold with ASA at age 80. Published results from the ASPREE trial have already shown that among older adults, ASA is no better than placebo in preventing CVD, and is no better than placebo in preventing a composite endpoint of death, disability, or dementia. The Mahady analysis provides the latest evidence-based nail-sealing-the-coffin of ASA use for primary prevention: it's ineffective for adults = age 70, plus it increases the risk for GI bleeding, especially in the presence of other bleeding risk factors. There now should be little doubt that primary prevention of CVD with ASA in contraindicated in adults = age 70.

Hemostasis and Thrombosis rater

There are increasingly frequent situations where clinicians are weighing the risks and benefits of ASA vs anticoagulant therapy. These data will be quite helpful in quantifying the impact of ASA on GI bleed risk.

Hemostasis and Thrombosis rater

Large rigorous study that confirms bleeding risk factors (age, NSAIDS, CKD, smoking) and provides data that can help quantify bleeding risk when considering benefits/risks of ASA in primary prevention.

Hemostasis and Thrombosis rater

Good data from an RCT to judge the risk for GI with ASA.

Public Health rater

The balance of benefits and risks with aspirin for primary prevention have been subject to much debate. This paper is helpful in that it presents absolute risks for bleeding by a number of risk factors. Clinicians can use this information to tailor their recommendations to their patients.
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