A study has found that bleeding in patients with nonvalvular atrial fibrillation (NVAF) and recent acute coronary syndrome (ACS) was reduced in patients receiving apixaban (Eliquis) versus vitamin K antagonists (VKAs).
Results from the Phase 4 AUGUSTUS trial were presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in March. The study, by the Bristol-Myers Squibb-Pfizer Alliance, was also published in the April 18 issue of the New England Journal of Medicine.
The researchers found that, in patients receiving antiplatelet therapies of a P2Y12 inhibitor with or without aspirin, the proportion of patients with major or clinically relevant nonmajor (CRNM) bleeding at six months was significantly lower for those treated with apixaban compared to those treated with a VKA (10.5% versus 14.7%, respectively).
“Due to concern for major bleeding, there have been ongoing questions about treating nonvalvular atrial fibrillation patients with acute coronary syndrome and/or undergoing percutaneous coronary intervention,” said Renato D. Lopes, MD, PhD, director of Clinical Events Classification at Duke Clinical Research Institute and principal investigator of AUGUSTUS. “Results from this study provide additional information for physicians treating these high-risk patients.”
The AUGUSTUS trial evaluated 4,614 patients in 33 countries.
Researchers also found 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% versus 9%, respectively).
In addition, at six months, patients receiving a P2Y12 inhibitor with or without aspirin who were treated with apixaban had lower rates of death or hospitalization (23.5% versus 27.4%, respectively) and similar rates of death or ischemic events (6.7% versus 7.1%) 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% versus 24.7%, respectively) and similar rates of death or ischemic events (6.5% versus 7.3%, respectively) compared to those assigned to placebo.
“Advancing care for patients at risk for stroke due to nonvalvular atrial fibrillation is a key focus of the BMS-Pfizer Alliance,” said Christoph Koenen, MD, head of cardiovascular development at Bristol-Myers Squibb. “The AUGUSTUS trial represents our ongoing commitment to understanding anticoagulation among higher-risk patients.”