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Annual risk of major bleeding among persons without cardiovascular disease not receiving antiplatelet therapy

JAMA Jul 05, 2018

Selak V, et al. - In this prospective cohort study, researchers assessed the risk of major bleeding in individuals without cardiovascular disease (CVD) who were not receiving antiplatelet therapy. Data revealed the annual risk of major bleeding events and nonfatal major bleeding estimated in a population not receiving antiplatelet therapy, and those estimates are below for the different groups assessed by researchers. The results obtained from the study could inform population-level guidelines for primary prevention of CVD.

Methods

  • Between 2002 and 2015, 359,166 people aged 30 to 79 years receiving primary care in New Zealand who had CVD risk assessment were involved.
  • After that, members 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.
  • After excluding individuals with medical conditions linked with increased bleeding risk (non-high-risk cohort; n=305,057) and after excluding individuals receiving other medications associated with increased bleeding risk (nonmedication cohort; n=240,254), researchers repeated their analyses.
  • Risk of a major bleeding event (hospitalization or death associated with bleeding), nonfatal gastrointestinal tract bleeding, and gastrointestinal tract bleeding-related case fatality were the main outcomes and measures.

Results

  • According to the data, mean participant age was 54 years (SD, 10 years), 44% were women, and 57% were European.
  • The study results showed that among the 359,166 people in the baseline cohort, 3,976 had a major bleeding event during 1,281,896 person-years of follow-up.
  • It was observed that most had gastrointestinal (GI) bleeding (n=2,910 [73%]).
  • Two hundred seventy-four fatal bleeding events (7%) were noted, of which 153 were intracerebral.
  • Data reported that the risk of a nonfatal GI bleeding event per 1,000 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.
  • It was found that case fatality related to 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.
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