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Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial

Mahady, SE, Margolis, KL, Chan, A, Polekhina, G, Woods, RL, Wolfe, R, Nelson, MR ORCID: 0000-0001-9941-7161, Lockery, JE, Wood, EM, Reid, C, Ernst, ME, Murray, A, Thao, LTP and McNeil, JJ 2020 , 'Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial' , Gut , pp. 1-8 , doi: 10.1136/gutjnl-2020-321585.

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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 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.

Item Type: Article
Authors/Creators:Mahady, SE and Margolis, KL and Chan, A and Polekhina, G and Woods, RL and Wolfe, R and Nelson, MR and Lockery, JE and Wood, EM and Reid, C and Ernst, ME and Murray, A and Thao, LTP and McNeil, JJ
Keywords: aspirin, clinical trials, elderly, epidemiology, gastrointestinal bleeding
Journal or Publication Title: Gut
Publisher: B M J Publishing Group
ISSN: 0017-5749
DOI / ID Number: 10.1136/gutjnl-2020-321585
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Copyright 2020 Author(s) (or their employer(s))

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