Bleeding risk, protective effects of aspirin for primary CVD prevention must be weighed
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The current literature does not support the use of aspirin for primary prevention in patients with diabetes, and physicians must balance the benefits of prevention with the increased risk for major bleeding, according to a speaker.
At the virtual Heart in Diabetes Conference, Richard C. Becker, MD, FAHA, professor of medicine and director of the Heart, Lung and Vascular Institute at the University of Cincinnati College of Medicine, discussed current research on the use of aspirin for primary prevention in atherosclerotic CVD and in patients with diabetes.
“We have to find the happy medium. We have to find the balance and decide who is at greatest likelihood of benefit while minimizing risk. This is part of a continuum. This is not a one-time assessment that would hold true for months or years to follow,” Becker said during the presentation. “We, as clinicians, need to continue to assess our patients for their risk of an atherosclerotic cardiovascular disease-related event and the risk for bleeding. The efficacy/safety balance will change over time and our recommendations should change accordingly. This is what our patients expect.”
Current research in aspirin for prevention
In his presentation, Becker cited recent trials that evaluated the efficacy and safety of aspirin for patients of varying age and comorbidities.
The ARRIVE trial included a cohort of patients at moderate risk for ASCVD randomly assigned to aspirin 100 mg daily or placebo. For this trial, researchers excluded those with diabetes and found no difference for the cumulative incidence of CV events between aspirin and placebo, but observed a twofold increase in risk for major bleeding, Becker said.
The ASPREE trial evaluated healthy patients older than 70 years with no known CVD who were randomly assigned to daily aspirin or placebo. For this trial, researchers also observed no difference in risk for CVD-related events, including ischemic stroke, between the aspirin and control groups. However, there was a 38% increase in risk for major bleeding among patients on daily aspirin, he said.
Lastly, the ASCEND trial, which exclusively enrolled patients with diabetes (mostly type 2) and no prior CVD, evaluated the efficacy and safety of aspirin compared with placebo. There was a decrease in risk for CV events (number needed to treat = 91), but this association was offset by a 29% increase in risk for significant bleeding (number needed to harm = 111), Becker said.
Current guidance on aspirin use
Becker cited the following as key points from the 2019 American College of Cardiology/American Heart Association guideline on primary prevention:
- In recent trials of aspirin for primary prevention, the estimated risk for ASCVD generally exceeded the actual risk observed during follow-up.
- ASCVD risk generally tracks with bleeding risk.
- There was insufficient evidence to recommend a specific risk threshold as an inclusion criterion for aspirin.
- Clinicians should consider the totality of evidence for ASCVD risk and tailor decisions about prophylactic aspirin to patient and clinician preferences.
“The cardiology community, myself included, has looked at a risk calculator to make a decision,” Becker said during the presentation. “This was a group recommendation, the [ACC/AHA] and other large governing bodies, to make clear that in recent cohort studies and trials the estimated atherosclerotic cardiovascular disease risk exceeded the actual risks observed during follow-up; meaning that we all overestimated what the risk of an atherosclerotic event might be.
“The committee felt that there was insufficient evidence to recommend a specific risk threshold as an inclusion criterion for aspirin,” Becker said in the presentation. “That makes it challenging because we would like to use scores and we would like to use the evidence, but the conclusion from this combined statement was that clinicians should consider the totality of evidence, where appropriate, of risk-enhancing factors such as family history of premature MI, inability to achieve control of lipids or control of blood sugar targets and elevation of calcium scores, and tailor the prophylactic use of aspirin to achieve benefit and minimize risk. This is a challenge.”
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Becker RC. Antithrombotic Therapy in Diabetes Mellitus. Presented at: Heart in Diabetes CME Conference; Aug. 21-24, 2020 (virtual meeting).
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