Stroke/TIA: major bleeds rare but higher with clopidogrel + aspirin

  • Tillman H & al.
  • JAMA Neurol
  • 29 Apr 2019

  • International Clinical Digest
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Takeaway

  • Among patients with transient ischemic attack (TIA) or minor acute ischemic stroke, short-term risk for major hemorrhage with antiplatelet therapy was low overall, but higher when clopidogrel (Plavix, others) was added to aspirin.

Why this matters

  • TIA and minor acute ischemic stroke carry elevated risk for new ischemic stroke, especially in early period.
  • Aspirin is current standard of care.

Key results

  • Incidence of major hemorrhage: 0.9% with clopidogrel plus aspirin, 0.2% with placebo plus aspirin (HR, 3.57; P=.003).
  • Number needed to harm: 159.
  • 4 fatal hemorrhages (0.1%):
    • 3 with clopidogrel plus aspirin (0.1%),
    • 1 with placebo plus aspirin (0.1%).
  • 7 intracranial hemorrhages (0.1%):
    • 5 with clopidogrel plus aspirin (0.2%),
    • 2 with placebo plus aspirin (0.1%).
  • Most common major hemorrhage location: gastrointestinal tract.

Study design

  • Secondary analysis of POINT multinational randomized controlled trial among 4881 patients with high-risk TIA or minor acute ischemic stroke, all given open-label aspirin (50-325 mg/day).
  • Randomization within 12 hours of symptom onset: clopidogrel (600-mg loading dose on day 1, then 75 mg daily for days 2-90) vs placebo.
  • Main outcome: major hemorrhage during mean 90-day follow-up.
  • Funding: National Institute of Neurological Disorders and Stroke; Sanofi.

Limitations

  • Small number of major hemorrhages.
  • Longer-term outcomes unclear.