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#Grand Rounds

Does Low-Dose Aspirin Reduce Risk of First Cardiovascular Events in Individuals at Moderate Risk?

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BACKGROUND AND PURPOSE:

  • There is evidence that low-dose aspirin is beneficial to those individuals who have acute coronary syndromes or previous myocardial infarction, stroke or TIA
  • The use of low-dose aspirin in those at moderate risk to prevent a first cardiovascular event is controversial
  • There is evidence that aspirin may prevent colon cancer
  • Gaziano et al. (The Lancet, 2018) assessed the efficacy and safety of aspirin in patients with moderate estimated risk of a first cardiovascular event

METHODS:

  • Randomized, double-blind, placebo-controlled, multicenter study (RCT)
    • Patients at moderate risk of cardiovascular disease (CD)
    • Moderate risk: 10-year risk of coronary heart disease of 10-20%
  • Risk Factors
    • High cholesterol
      • Men: Total cholesterol >200 mg/dL (5.180 mmol/L) or LDL >130 mg/dL (3.367 mmol/L)
      • Women: Total cholesterol >240 mg/dL (6.126 mmol/L) or LDL >160 mg/dL (4.144 mmol/L)
    • Current smoking: Any cigarette smoking in the past 12 months
    • Low HDL cholesterol: <40 mg/dL
    • High blood pressure: Systolic BP >140 mm Hg
    • Receiving medication to treat high blood pressure
    • Positive family history of CVD
  • Patients
    • Men: ≥55 years | 2 to 4 risk factors
    • Women: ≥60 years | ≥3 risk factors
  • Patients were randomly assigned to receive either
    • Enteric-coated aspirin tablets (100 mg)
    • Placebo tablets
  • Median follow up was 60 months
  • Primary outcome: Composite outcome of
    • Time to first occurrence of cardiovascular death | Myocardial infarction | Unstable angina | Stroke | TIA
  • Safety endpoints
    • Hemorrhagic events
    • Incidence of other adverse events

RESULTS:

  • 12,546 patients were enrolled and randomized
    • Aspirin 6270 | Placebo 6276
  • Fatal or non-fatal myocardial infarction was similar between groups (p=0.2325)
    • 1.52% patients in the aspirin group
    • 1.78% patients in the placebo group
    • Hazard ratio (HR) 0.85; 95% CI, 0.64–1.11
  • Composite cardiovascular outcome was similar between the 2 groups (p=0·6038)
    • 269 (4.29%) patients in the aspirin group
    • 281 (4.48%) patients in the placebo group
    • HR 0.96; 95% CI, 0.81–1.13
  • There was no significant difference in myocardial infarction in the intention-to-treat group, although this was significant in the ‘in-protocol’ group
  • Gastrointestinal bleeding events (mostly mild) occurred more commonly in the aspirin group (p=0·0007)
    • 61 (0.97%) patients in the aspirin group
    • 29 (0.46%) in the placebo group
    • HR 2.11; 95% CI, 1.36–3.28
  • The overall incidence of adverse events was similar in both treatment groups
  • Overall incidence of treatment-related adverse events was more common in the aspirin group (p<0.0001)
    • 16.75% patients in the aspirin group
    • 13.54% in the placebo group
  • There were 321 documented deaths and were similar in both groups
    • 2.55% in the aspirin group vs 2.57% in the placebo group

CONCLUSION:

  • The event rate was lower than predicted and therefore reflects a low-risk rather than moderate-risk population (reflective of improved medical management)
  • The study, therefore, does not address moderate-risk individuals
  • In low risk patients, there needs to be a balance between low prevention impact and high bleeding risk of low-risk aspirin for those at low-risk CD populations

Learn More – Primary Sources:

Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease: a randomized, double-blind, placebo-controlled trial

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Related ObG Topics:

Low Dose Aspirin and Breast Cancer Prevention – Results from the CTS Cohort
Patient with Stable CVD: Rivaroxaban, Aspirin or Both to Prevent Recurrent Events?

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