Evidence map›Paper›PMID 32747412›Full record

Trial reportGut2021

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

Suzanne E Mahady, Karen L Margolis, Andrew Chan, Galina Polekhina, Robyn L Woods, Rory Wolfe, Mark R Nelson, Jessica E Lockery, Erica M Wood, Christopher Reid and 4 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01038583 (Aspirin in Reducing Events in the Elderly), which is not on this map. Cited by 62 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 5 pooled it
10.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01038583 unknown statusnot on this map

Aspirin in Reducing Events in the Elderly

TypeobservationalSponsorHennepin Healthcare Research InstituteRan2010 to 2024Enrolled19,114ConditionsFunctional Disability, Dementia, Heart Disease, StrokeArms100 mg enteric-coated aspirin, Placebo
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 5 syntheses or guidelines pooled it, 130 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Management of Peptic Ulcer Disease in Patients Taking Antithrombotic Agents.The Korean journal of helicobacter and upper gastrointestinal research · 2026
    Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Gastro-Esophageal Disorders of the Geriatric Population.The American journal of gastroenterology · 2025
    Article
  20. Review

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 2 countries.

Suzanne E MahadySchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia suzanne.mahady@monash.edu.ORCID 0000-0002-6788-2250
Karen L MargolisHealthPartners Institute, Minneapolis, Minnesota, USA.
Andrew ChanClinical and Translational Epidemiology Unit, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
Galina PolekhinaSchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
Robyn L WoodsSchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
Rory WolfeSchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
Mark R NelsonMenzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.
Jessica E LockerySchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
Erica M WoodSchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
Christopher ReidSchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
Michael E ErnstDepartment of Pharmacy Practice and Science, College of Pharmacy, The University of Iowa, Iowa City, Iowa, USA.
Anne MurrayDivision of Geriatrics, Department of Medicine, Hennepin Healthcare, University of Minnesota, Minneapolis, Minnesota, USA.
Ltp ThaoSchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
John J McNeilSchool of Public Health & Preventive Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Melbourne, Victoria, Australia.
Monash University · AUCurtin University · AUHealthPartners · USMassachusetts General Hospital · USMonash Health · AUUniversity of Iowa · USUniversity of Minnesota · USUniversity of Tasmania · AU

Funding

ASPirin in Reducing Events in the ElderlyU01AG029824 · NIA · HENNEPIN HEALTHCARE RESEARCH INSTITUTE · PI MCNEIL, JOHN JAMES, MURRAY, ANNE M · 2009 to 2018
$64.6M
Main Administrative CoreU19AG062682 · NIA · HENNEPIN HEALTHCARE RESEARCH INSTITUTE · PI WOODS, ROBYN LORRAINE · 2019 to 2023
$42.9M
Research Education CoreP30AG024824 · NIA · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Neil Alexander · 2004 to 2026
$29.2M
Precision Prevention Research ProgramR35CA253185 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI Andrew T Chan · 2020 to 2026
$6.9M
NCI NIH HHS R35 CA253185NIA NIH HHS P30 AG024824NIA NIH HHS U01 AG029824NIA NIH HHS U19 AG062682
6 · The paper itself

Abstract

objectiveThere 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.

designData 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.

resultsOver 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.

conclusionAspirin 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.

Indexed as

AgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalAspirinAustraliaDouble-Blind MethodFemaleGastrointestinal HemorrhageHumansIncidenceIndependent LivingMalePrimary PreventionRisk FactorsUnited StatesAnti-Inflammatory Agents, Non-SteroidalAspirinaspirinclinical trialselderlyepidemiologygastrointestinal bleeding

Identifiers

PMID32747412
PMCPMC7957959
OpenAlexW3047450016

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.