Favorable safety results for Eliquis versus Vitamin K in NVAF

18 March 2019

Bristol-Myers Squibb (NYSE: BMY) and alliance partner Pfizer (NYSE: PFE) on Sunday announced positive 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), at the American College of Cardiology’s (ACC) 68th Annual Scientific Session 2019 in New Orleans.

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; hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.58-0.81; p-superiority<0.001).

AUGUSTUS, which evaluated 4,614 patients, is an open-label, prospective, randomized clinical trial designed to assess two independent hypotheses:

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