Results from the phase 4 AUGUSTUS trial, evaluating apixaban vs vitamin K antagonists (VKAs) in patients with nonvalvular atrial fibrillation (NVAF) and recent acute coronary syndrome (ACS) and/or undergoing percutaneous coronary intervention (PCI), were announced at the American College of Cardiology (ACC) 68th Annual Scientific Sessions 2019 in New Orleans, LA.

The AUGUSTUS study was an international, randomized controlled trial that included 4614 patients receiving P2Y12 inhibitor therapy for at least 6 months. Patients were randomized to receive open-label apixaban or a VKA and to receive double-blind aspirin or matching placebo for 6 months. The primary outcome was the composite of major or clinically relevant non-major (CRNM) bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH); secondary endpoints included the composite of death or hospitalization and the composite of death or ischemic events.

Findings from the study showed that the proportion of patients with major or CRNM bleeding was significantly lower in the apixaban group compared with the VKA group (10.5% vs 14.7%, respectively; hazard ratio [HR] 0.69, 95% CI, 0.58–0.81; P <.001). Moreover, treatment with apixaban led to a lower incidence of death or hospitalization (23.5% vs 27.4%, respectively; HR 0.83, 95% CI, 0.74–0.93; P =.002) and a similar overall incidence of death or ischemic events (6.7% vs 7.1%, respectively; HR 0.93, 95% CI, 0.75–1.16; P =NS) when compared with VKA treatment.

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In addition, the study showed that among patients who received P2Y12 inhibitor therapy and an anticoagulant, significantly more patients receiving aspirin had major or CRNM bleeding compared with those receiving placebo (16.1% vs 9.0%, respectively; HR 1.89, 95% CI, 1.59–2.24; P <.001). Similar rates of death or hospitalization (26.2% vs 24.7%, respectively; HR 1.08, 95% CI, 0.96–1.21; P =NS) and death or ischemic events (6.5% vs 7.3%, respectively; HR 0.89, 95% CI, 0.71–1.11) were noted between the aspirin and placebo groups.

“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, MHS, PhD, Director, Clinical Events Classification, Duke Clinical Research Institute and Principal Investigator of AUGUSTUS. “Results from this study provide additional information for physicians treating these high-risk patients.”

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