AUGUSTUS: Less Bleeding, Fewer Events With Apixaban and No Aspirin in Patients With AFib and ACS

Patients with both atrial fibrillation (AFib) and acute coronary syndrome (ACS) had a significantly reduced risk of bleeding when treated with apixaban vs. a vitamin K antagonist (VKA) and when taking placebo vs. aspirin, according to results of the AUGUSTUS trial presented at ACC.19 in New Orleans. The results were also published simultaneously in the New England Journal of Medicine.

A total of 4,614 patients (median age, 70.7 years; 29 percent women) were enrolled and randomized within 14 days (mean, 6.6 days) of an ACS episode or stent insertion to apixaban (5 mg twice daily) or VKA and to either a daily baby aspirin or matching placebo. All patients were required to be taking clopidogrel (90 percent did) or another P2Y12 inhibitor during the trial. The primary endpoint was major or clinically relevant nonmajor bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) definition. Secondary endpoints included a composite of death or hospitalization and a composite of death or stroke, heart attack, stent thrombosis or urgent revascularization.

After six months, the bleeding risk was reduced by 31 percent among patients taking apixaban vs. warfarin (p<0.001) and by 47 percent among patients taking placebo vs. aspirin. The highest bleeding rates were reported among patients treated with VKA and aspirin (18.7 percent) and the lowest rates occurred among those taking clopidogrel, apixaban and placebo (7.3 percent).

A primary endpoint event occurred in 10.5 percent of patients taking apixaban vs. 14.7 percent taking a VKA (p<0.001 for noninferiority and superiority). This event rate was 16.1 percent with aspirin and 9 percent with placebo (hazard ratio, 1.89; p<0.001). The number needed to treat to avoid one primary event was 24 with apixaban vs. VKA.

Deaths and hospitalizations were highest in patients taking VKA and aspirin (27.5 percent) and lowest for those taking apixaban and placebo (22.0 percent). Patients in the apixaban group had a 50 percent lower risk of stroke compared with those taking VKA.

“We have shown that when it comes to treating this high-risk patient population, less may be more,” said lead author Renato D. Lopes, MD, PhD, FACC. “Our findings show that the combination of apixaban and a drug such as clopidogrel – without aspirin – is the safest treatment regimen for this difficult-to-treat group of patients, without significantly increasing ischemic events such as heart attacks, strokes and blood clots.”

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention, Anticoagulation Management and ACS, Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Interventions and ACS

Keywords: ACC19, ACC Annual Scientific Session, Atrial Fibrillation, Aspirin, Acute Coronary Syndrome, Anticoagulants, Percutaneous Coronary Intervention, Vitamin K, Pyridones, Pyrazoles, Arrhythmias, Cardiac

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