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Published on: March 15, 2022
Risk of bleeding after hospitalization for a serious coronary event: a retrospective cohort study with nested
Antonio González-Pérez1,2, María E Sáez1,2, Saga Johansson3
1Spanish Centre for Pharmacoepidemiologic Research (CEIFE), Madrid, Spain.
Insights
Serious coronary event patients using combined antithrombotic therapy faced higher hemorrhagic stroke risk. Combined antiplatelet therapy increased upper gastrointestinal bleeding risk, while clopidogrel use raised lower gastrointestinal bleeding risk.
Area of Science:
- Cardiology
- Pharmacology
- Epidemiology
Background:
- Bleeding events are a known risk associated with antiplatelet agent use.
- This study investigates bleeding event incidence in patients with prior serious coronary events.
Purpose of the Study:
- To estimate bleeding event incidence in patients hospitalized for serious coronary events.
- To determine bleeding risks associated with acetylsalicylic acid (ASA) and/or clopidogrel use.
Main Methods:
- Utilized a UK primary care database to identify 27,707 patients aged 50-84 hospitalized for serious coronary events (2000-2007).
- Followed patients until an endpoint (hemorrhagic stroke, upper/lower GI bleeding), death, or study end (June 2011).
- Employed a nested case-control analysis to identify bleeding risk factors.
Main Results:
- Incidences per 10,000 person-years: hemorrhagic stroke (5.0), upper GI bleeding (UGIB) (11.9), and lower GI bleeding (LGIB) (25.5), increasing with age.
- Combined antithrombotic therapy (warfarin + antiplatelets) increased hemorrhagic stroke risk (OR, 6.36).
- Combined antiplatelet therapy (clopidogrel + ASA) increased UGIB risk (OR, 2.42), and clopidogrel use increased LGIB risk (OR, 1.86).
Conclusions:
- Combined antithrombotic therapy is linked to increased hemorrhagic stroke risk.
- Combined antiplatelet therapy is associated with a higher risk of UGIB.
- ASA use was not significantly associated with increased bleeding risk; non-use was rare.
Background:
Bleeding events have been associated with the use of antiplatelet agents. This study estimated the incidence of bleeding events in patients previously hospitalized for a serious coronary event and determined the risks of bleeding associated with the use of acetylsalicylic acid (ASA) and/or clopidogrel.
Methods:
A UK primary care database was used to identify 27,707 patients aged 50 to 84 years, hospitalized for a serious coronary event during 2000 to 2007 and who were alive 30 days later (start date). Patients were followed up until they reached an endpoint (hemorrhagic stroke, upper or lower gastrointestinal bleeding [UGIB/LGIB]), death or end of study [June 30, 2011]) or met an exclusion criterion. Risk factors for bleeding were determined in a nested case-control analysis.
Results:
Incidences of hemorrhagic stroke, UGIB, and LGIB were 5.0, 11.9, and 25.5 events per 10,000 person-years, respectively, and increased with age. UGIB and LGIB led to hospitalization in 73 and 23 % of patients, respectively. Non-users of ASA, who were mostly discontinuers, and current users of ASA had similar risks of hemorrhagic stroke, UGIB, and LGIB. Users of combined antithrombotic therapy (warfarin and antiplatelets) experienced an increased risk of hemorrhagic stroke (odds ratio [OR], 6.36; 95 % confidence interval [CI], 1.34-30.16), whereas users of combined antiplatelet therapy (clopidogrel and ASA) experienced an increased risk of UGIB (OR, 2.42; 95 % CI, 1.09-5.36). An increased risk of LGIB (OR, 1.86; 95 % CI, 1.34-2.57) was also observed in users of clopidogrel.
Conclusions:
In patients previously hospitalized for a serious coronary event, combined antithrombotic therapy was associated with an increased risk of hemorrhagic stroke, whereas combined antiplatelet therapy was associated with an increased risk of UGIB.Non-use of ASA was rare in this population and use of ASA was not associated with a significantly increased risk of hemorrhagic stroke, UGIB, or LGIB.
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