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Original Investigation
June 26, 2018

Annual Risk of Major Bleeding Among Persons Without Cardiovascular Disease Not Receiving Antiplatelet Therapy

Author Affiliations
  • 1Section of Epidemiology and Biostatistics, University of Auckland, Auckland, New Zealand
  • 2Middlemore Hospital, Auckland, New Zealand
  • 3Te Kupenga Hauora Māori, University of Auckland, Auckland, New Zealand
JAMA. 2018;319(24):2507-2520. doi:10.1001/jama.2018.8194
Key Points

Question  What is the risk of major bleeding among persons without cardiovascular disease who are not receiving antiplatelet therapy?

Findings  In this prospective cohort study of 359 166 people without cardiovascular disease who were not receiving antiplatelet therapy, the risk of a nonfatal major bleeding event per 1000 person-years ranged from 1.8 in men aged 30 to 39 years to 6.4 in men aged 70 to 79 years and from 1.5 in women aged 30 to 39 years to 5.0 in women aged 70 to 79 years.

Meaning  These findings provide baseline bleeding risk estimates that could inform decision making for prevention of cardiovascular disease.

Abstract

Importance  A decision to initiate aspirin therapy for primary prevention of cardiovascular disease (CVD) requires consideration of both treatment benefits and harms. The most significant harm associated with aspirin is major bleeding, yet there is a paucity of data on bleeding risk in suitable community populations.

Objective  To determine the risk of major bleeding among people without CVD who are not receiving antiplatelet therapy.

Design, Setting, and Participants  Prospective cohort study of 359 166 individuals aged 30 to 79 years receiving primary care in New Zealand who had CVD risk assessment between 2002 and 2015. Participants were censored at the earliest date on which they had a first major bleeding event, died, or met any baseline cohort exclusion criteria or the study end date of December 31, 2015. Analyses were repeated after excluding people with medical conditions associated with increased bleeding risk (non–high-risk cohort; n=305 057) and after further excluding people receiving other medications associated with increased bleeding risk (nonmedication cohort; n=240 254).

Exposures  Sex and age group in 10-year bands from 30 to 79 years.

Main Outcomes and Measures  Risk of a major bleeding event (hospitalization or death associated with bleeding); nonfatal gastrointestinal tract bleeding; and gastrointestinal tract bleeding–related case fatality.

Results  Mean participant age was 54 years (SD, 10 years), 44% were women, and 57% were European. Among the 359 166 individuals in the baseline cohort, 3976 had a major bleeding event during 1 281 896 person-years of follow-up. Most had gastrointestinal (GI) bleeding (n=2910 [73%]). There were 274 fatal bleeding events (7%), of which 153 were intracerebral. The risk of a nonfatal GI bleeding event per 1000 person-years was 2.19 (95% CI, 2.11-2.27), 1.77 (95% CI, 1.69-1.85) and 1.61 (95% CI, 1.52-1.69), in the baseline, non–high-risk, and nonmedication cohorts, respectively. Case fatality associated with GI bleeding was 3.4% (95% CI, 2.2%-4.1%), 4.0% (95% CI, 3.2%-5.1%), and 4.6% (95% CI, 3.6%-6.0%) in the baseline, non–high-risk, and nonmedication cohorts, respectively.

Conclusions and Relevance  In a population not receiving antiplatelet therapy, the annual risk of major bleeding events and nonfatal major bleeding was estimated. These findings could inform population-level guidelines for primary prevention of CVD.

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