AUGUSTUS trial demonstrates favourable safety results

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The Bristol-Myers Squibb-Pfizer Alliance has announced results from the Phase 4 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.

These data are featured as a late-breaking oral presentation at the American College of Cardiology’s (ACC) 68th Annual Scientific Session 2019 in New Orleans, LA (Abstract 405-08) and simultaneously published in the New England Journal of Medicine.

AUGUSTUS, which evaluated 4614 patients, is an open-label, prospective, randomised clinical trial designed to assess two independent hypotheses:

  • Whether or not Eliquis 5mg* twice daily is non-inferior or superior to VKAs for the outcome of major or CRNM bleeding, as defined by the International Society on Thrombosis and Haemostasis (ISTH), in patients with NVAF and recent ACS and/or undergoing PCI with planned concomitant antiplatelet therapy (a P2Y12 inhibitor with or without low-dose aspirin).
  • Whether or not single antiplatelet therapy with a P2Y12 inhibitor is superior to dual antiplatelet therapy with a P2Y12 inhibitor and low-dose aspirin for the outcome of ISTH major or CRNM bleeding in patients with NVAF and recent ACS and/or undergoing PCI and planned concomitant anticoagulant therapy (either Eliquis 5mg* twice daily or VKA).
    *2.5mg twice daily if patients met two or more of the following dose-reduction criteria: age ≥ 80 years, weight ≤ 60 kg or creatinine ≥ 1.5mg/dL (133 micromol/L).

Independent of the Eliquis versus VKA comparison, 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.

Eliquis increases the risk of bleeding compared with placebo and can cause serious, potentially fatal, bleeding. Dr Renato D. Lopes, M.H.S, Ph.D., Director, Clinical Events Classification, Duke Clinical Research Institute and Principal Investigator of AUGUSTUS, said: “Due to concern for major bleeding, there have been ongoing questions about treating non-valvular atrial fibrillation patients with acute coronary syndrome and/or undergoing percutaneous coronary intervention.

“Results from this study provide additional information for physicians treating these high-risk patients.”

Dr Christoph Koenen, Head of Cardiovascular Development, Bristol-Myers Squibb, said: “The AUGUSTUS trial represents our ongoing commitment to understanding anticoagulation among higher-risk patients.”