Afib after ACS, PCI: less bleeding with apixaban

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.