Afib after ACS, PCI: less bleeding with apixaban

  • Lopes RD & al.
  • N Engl J Med
  • 18 Apr 2019

  • International Clinical Digest
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Takeaway

  • After acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), patients with Afib have the fewest bleeding events and hospitalizations with apixaban (Eliquis; Pfizer and Bristol-Myers Squibb)+P2Y12 inhibitor. 
  • Editorial : 
    • Recommends routine direct oral anticoagulant (DOAC) for this population. 
    • Key unknown: whether coronary ischemia incidence rises without aspirin (for patients taking DOAC+clopidogrel [Plavix; Bristol-Myers Squibb]). 

Why this matters

  • Optimal antithrombotic regimen for these patients has been unclear, with competing risks among bleeding, cardioembolic stroke, and coronary ischemia.

Key results

  • Apixaban vs vitamin K antagonists (VKAs):
    • Primary outcome: 10.5% vs 14.7%.
    • HR, 0.69 (95% CI, 0.58-0.81; P<.001 noninferiority and superiority>
  • Aspirin vs placebo:
    • Primary outcome, 16.1% vs 9.0%.
    • HR, 1.89 (95% CI, 1.59-2.24; P<.001>
  • Highest bleeding rate (18.7%) with VKA/aspirin.
  • Lowest bleeding rate (7.3%) with apixaban/placebo. 
  • Lower death/hospitalization rate with apixaban, driven by fewer hospitalizations vs VKA.
  • Similar death/hospitalization, ischemia rates with aspirin vs placebo.

Study design

  • Randomized controlled multinational AUGUSTUS (N=4614), involving adults with Afib who were post-ACS and/or PCI.
  • Researchers randomly allocated participants to 6 months of:
    • apixaban vs VKA, or
    • aspirin vs placebo.
  • All took P2Y12 inhibitor.
  • Outcome: major or clinically relevant nonmajor bleeding events per 100 patient-years.
  • Funding: Bristol-Myers Squibb; Pfizer.

Limitations

  • Ischemia outcome exploratory.