Gastrointestinal bleeding risk may be higher than thought in primary CVD prevention
In a new cohort study, compared with estimates by the U.S. Preventive Services Task Force, risk for fatal or nonfatal gastrointestinal bleeding was higher in people without CVD not receiving antiplatelet therapy.
The data may inform whether aspirin is appropriate as a primary CVD prevention strategy.
“This study presents age- and sex-specific data, which could support the development of population-level guidelines,” the researchers wrote. “However, validated risk algorithms are required to take into account multiple risk factors at the same time, as with CVD itself, among people without CVD, to optimize the individualized assessment of the balance of absolute benefits and harms of aspirin for primary prevention of CVD.”
Vanessa Selak, PhD, senior lecturer in the section of epidemiology and biostatistics at University of Auckland School of Population Health Sciences in New Zealand, and colleagues estimated the annual risk for major bleeding events and nonfatal major bleeding in 359,166 participants who underwent CVD risk assessment with their primary care physician or nurse between Aug. 27, 2002, and June 30, 2015, in New Zealand.
Information considered in the CVD risk assessment included CV risk factors, history and medication use. Other data assessed in the study included demographic data, publicly funded hospitalizations, deaths and subsidized pharmaceutical dispensing.
Participants were censored at the earliest date of death, first major bleeding event or baseline cohort exclusion criteria, including the dispensing of antiplatelet, aspirin or anticoagulant medication.
Researchers also analyzed the cohort after censoring for patients with conditions associated with elevated bleeding (n = 305,057) and for patients taking medications that increased bleeding risk (n = 240,254).
The primary outcome was a first major bleeding event, which included hospitalization or death that was associated with bleeding.
The mean age for participants was 54 years, and 44% were women. Participants were followed up for a median of 2.8 years.
During 1,281,896 person-years of follow-up, 1.1% of the baseline cohort had a major bleeding event, 73% of which was gastrointestinal bleeding. Fatal bleeding events occurred in 7% of the baseline cohort, and 56% of those events were intracerebral.
Participants in the baseline cohort had an increased risk for nonfatal gastrointestinal bleeding event (2.19 per 1,000 person-years; 95% CI, 2.11-2.27) compared with the non-high-risk cohort (1.77 per 1,000 person-years; 95% CI, 1.69-1.85) and the nonmedication cohort (1.61 per 1,000 person-years; 95% CI, 1.52-1.69).
Case fatality associated with gastrointestinal bleeding was 3.4% in the baseline cohort (95% CI, 2.8-4.1), 4% for the non-high-risk cohort (95% CI, 3.2-5.1) and 4.6% in the nonmedication cohort (95% CI, 3.6-6). – by Darlene Dobkowski
Disclosure s : Selak reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.