Phase IV AUGUSTUS trial of Eliquis shows superiority in non-valvular atrial fibrillation

Bristol-Myers Squibb/Pfizer announced results from the Phase IV AUGUSTUS trial evaluating Eliquis (apixaban) versus vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) and recent acute coronary syndrome (ACS) and/or undergoing percutaneous coronary intervention (PCI). Results show that in patients receiving a P2Y12 inhibitor with or without aspirin (antiplatelet therapies), the proportion of patients with major or clinically relevant non-major (CRNM) bleeding at six months was significantly lower for those treated with Eliquis compared to those treated with a VKA (10.5% vs. 14.7%, respectively).

Results also showed that in patients receiving a P2Y12 inhibitor and an anticoagulant, the proportion of patients with major or CRNM bleeding at six months was significantly higher for those receiving aspirin compared to those receiving placebo (16.1% vs. 9.0%, respectively. The investigators also analyzed the pre-defined secondary composite outcomes of death or hospitalization and death or ischemic events (including myocardial infarction, stroke, definite or probable stent thrombosis or urgent revascularization).

At six months, patients receiving a P2Y12 inhibitor with or without aspirin who were treated with Eliquis had lower rates of death or hospitalization (23.5% vs. 27.4%, respectively) and similar rates of death or ischemic events (6.7% vs. 7.1%, respectively) compared to those assigned to VKA. Patients receiving a P2Y12 inhibitor and an anticoagulant who were treated with aspirin had similar rates of death or hospitalization (26.2% vs. 24.7%, respectively) and similar rates of death or ischemic events (6.5% vs. 7.3%, respectively) compared to those assigned to placebo. These data are featured at the American College of Cardiology’s (ACC) 68th Annual Scientific Session 2019 and simultaneously published in the New England Journal of Medicine.

See: "Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation" Renato D. Lopes et al. NEJM March 17, 2019 DOI: 10.1056/NEJMoa1817083