A Study of Cardiovascular Events in Diabetes - ASCEND Aspirin

Contribution To Literature:

The ASCEND Aspirin trial showed that the absolute reduction in cardiovascular events from aspirin was offset by a similar absolute increase in major bleeding. 

Description:

The goal of the trial was to evaluate aspirin compared with placebo among diabetics with no known cardiovascular disease (CVD).


Study Design

  • Randomized
  • Parallel
  • Factorial

Patients with diabetes and no known CVD were randomized to aspirin 100 mg daily (n = 7,740) versus placebo (n = 7,740).

  • Total number of enrollees: 15,480
  • Duration of follow-up: mean 7.4 years
  • Mean patient age: 63 years
  • Percentage female: 37%

Inclusion criteria:

  • Diabetic patients ≥40 years of age without known CVD

Exclusion criteria:

  • Clear indication or contraindication to aspirin

Principal Findings:

The primary efficacy outcome, major adverse cardiovascular events (vascular death, myocardial infarction, or stroke/transient ischemic attack), occurred in 8.5% of the aspirin group compared with 9.6% of the placebo group (p = 0.01).

The primary safety outcome, major bleeding (intracranial hemorrhage, gastrointestinal [GI] hemorrhage, or sight-threatening eye bleeding), occurred in 4.1% of the aspirin group compared with 3.2% of the placebo group (p = 0.003).

The reduction in adverse events or increase in bleeding events was similar among different categories of baseline risk.

Secondary outcomes:

  • Nonfatal myocardial infarction: 2.5% with aspirin vs. 2.5% with placebo (p = not significant [NS])
  • Intracranial hemorrhage: 0.7% with aspirin vs. 0.6% with placebo (p = NS)
  • GI hemorrhage: 1.8% with aspirin vs. 1.3% with placebo (p < 0.05)
  • GI cancer: 2.0% with aspirin vs. 2.0% with placebo (p = NS)

Interpretation:

Among diabetic patients with no known CVD, aspirin was associated with a 12% relative reduction in major adverse cardiovascular events compared with placebo. Aspirin was associated with a 29% relative increase in major bleeding events compared with placebo. The increase in bleeding was mainly due to GI hemorrhage. The absolute risk reduction for major adverse cardiovascular events was 1.1%, while the absolute risk increase for major bleeding was 0.9%. There was no reduction in GI cancer from the use of aspirin. The use of aspirin among diabetics with no known CVD needs to be individualized.

References:

The ASCEND Study Collaborative Group. Effects of Aspirin for Primary Prevention in Persons With Diabetes Mellitus. N Engl J Med 2018;379:1529-39.

Editorial: Ridker PM. Should Aspirin Be Used for Primary Prevention in the Post-Statin Era? N Engl J Med 2018;379:1572-4.

Presented by Dr. Jane Armitage at the European Society of Cardiology Congress, Munich, Germany, August 26, 2018.

Clinical Topics: Anticoagulation Management, Diabetes and Cardiometabolic Disease, Prevention

Keywords: ESC Congress, ESC18, Anticoagulants, Aspirin, Diabetes Mellitus, Hemorrhage, Intracranial Hemorrhages, Ischemic Attack, Transient, Metabolic Syndrome X, Myocardial Infarction, Neoplasms, Primary Prevention, Stroke, Vascular Diseases


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