Mitchell S.V. Elkind, M.D., is American Heart Association president-elect, chair of the Advisory Committee of the American Stroke Association — a division of the American Heart Association and professor of neurology and epidemiology at Columbia University New York. 

copyright American Heart Association

"The AUGUSTUS Trial was a study that looked at a complicated group of patients. These are patients who have Atrial Fibrillation as well as either Acute Coronary Syndrome, like a heart attack, or undergo a Percutaneous Coronary Intervention, or PCI. These are challenging patients because they often require anticoagulation for the Atrial Fibrillation as well as antiplatelet agents for the coronary intervention, the recent heart attacks, then perhaps the displaced coronary artery. And so, the question has always been: How many blood thinners should these patients be on? 

Potentially, they could be on three different agents: anticoagulant for the AFIB, and dual antiplatelets, two antiplatelet agents for the coronary procedure that's done, and we know that all of those things together pretty dramatically increase the risk of bleeding. And, so the AUGUSTUS Trial itself tested whether in that setting, right, AFIB and a coronary event, using Warfarin, or one of the newer oral anticoagulants, what are called the Direct Acting Oral Anticoagulants, or DOAC, in this case, Apixiban, which of those was better to use in this setting, both safer and potentially more effective, and in a factorial design, they also tested the addition of Aspirin or a placebo to another antiplatelet agent. Right. So they wanted to see whether patients needed to be on Asprin as well as typically Clopidogrel or another agent that we'd use for a patient with a stint. 

This analysis is a sub-study analysis of the overall AUGUSTUS Trial, in which they looked at a sub-group of patients who had a history of stroke, TIA, or systemic Thromboembolism to see whether the results that we're seeing in the overall trial also held through for patients with history of Cerebrovascular disease. And essentially, what they found was that Apixiban was more effective than Warfarin, and had a lower risk of bleeding than Warfarin for patients with a history of Cerebrovascular disease, just as it was in those without. There were about 15% of the patients in the overall AUGUSTUS Trial who had either Cerebrovascular disease or systemic Thromboembolism. So, this was a small sub-group from the overall trial. The trial itself was large, so it's a significant number of patients who met this criteria. So, overall the results confirmed that even in a group of patients who may be considered at high-risk because they have a prior history of Cerebrovascular disease. 

Number one: The use of Apixiban instead of Warfarin seemed to be safer and that those patients did not need to be on Aspirin as well as their other antiplatelet agent. Patients with a history of stroke, in fact, had a lower risk of bleeding than the other patients in this trial. And, so, one could argue that they should be on an agent like Apixiban, as well as an alternate antiplatelet agent, like Clopidogrel, for example, without the addition of Aspirin. There's no clear reason to add Aspirin as well."