Antithrombic Therapy in AF Patients After ACS/PCI

Quick Takes

  • Apixaban is associated with lower rates of bleeding than vitamin K antagonists regardless of baseline bleeding risk in patients with AF and ACS/PCI.
  • Use of aspirin versus placebo is associated with higher rates of death or hospitalization for patients at high stroke risk.
  • The use of apixaban and P2Y12 therapy should be first-line treatment for most patients with AF and ACS/PCI regardless of baseline stroke or bleeding risk.

Study Questions:

What are the safety and efficacy of antithrombotic regimens according to HAS-BLED and CHA2DS2-VASc scores in the AUGUSTUS trial?

Methods:

The authors conducted a secondary analysis of the AUGUSTUS randomized clinical trial comparing apixaban versus vitamin K antagonist (VKA) therapy as well as comparing aspirin versus placebo in patients with comorbid atrial fibrillation (AF) and acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI). The primary outcomes were major or clinically relevant nonmajor bleeding as well as death or hospitalization over 6 months of follow-up. Cox proportional hazards models were used to assess treatment effects by baseline HAS-BLED score (≤2 vs. ≥3) and CHA2DS2-VASc score (≤2 vs. ≥3).

Results:

Among the 4,386 (95.1%) patients with calculable scores, 66.8% had a HAS-BLED score ≥3 and 81.7% had a CHA2DS2-VASc score ≥3. Bleeding rates were lower with apixaban versus VKA in both the low and high HAS-BLED score groups (hazard ratio [HR], 0.57 [0.41-0.78] and 0.72 [0.59-0.88], respectively). Aspirin increased bleeding in both HAS-BLED groups as well (HR, 1.86 [1.36-2.56] and 1.81 [1.47-2.23], respectively). Apixaban was associated with a lower risk of death or hospitalization as compared to VKA among patients with a high CHA2DS2-VASc risk score (HR, 0.82 [0.73-0.94]). The pinteraction for low versus high CHA2DS2-VASc score was not statistically significant for death or hospitalization.

Conclusions:

The authors concluded that the use of apixaban and a P2Y12 inhibitor without aspirin is safe and effective for most patients with AF and ACS/PCI regardless of baseline bleeding or stroke risk.

Perspective:

The AUGUSTUS trial was the largest trial to compare the use of a direct oral anticoagulant to VKA and to explore the safety and efficacy of “double therapy” (anticoagulant + P2Y12) versus “triple therapy” (anticoagulant + P2Y12 + aspirin). This analysis confirms the overall study findings that apixaban was safer than VKA and that aspirin therapy led to increased risks of bleeding. This analysis provides reassurance that baseline bleeding and stroke risk do not meaningfully impact that top-line analysis of the AUGUSTUS trial. Clinical guidelines have now adopted a “dual therapy” approach as first-line treatment for most patients with comorbid AF and ACS/PCI, especially after the first 7-30 days.

Keywords: Acute Coronary Syndrome, Anticoagulants, Arrhythmias, Cardiac, Aspirin, Atrial Fibrillation, Fibrinolytic Agents, Hemorrhage, Percutaneous Coronary Intervention, Risk Factors, Secondary Prevention, Stroke, Vitamin K


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