Prof Renato D. Lopes (Duke University Medical Center, Durham, NC, US) discusses AUGUSTUS – an open-label, 2×2 factorial, RCT to evaluate the safety of apixaban versus VKA and aspirin versus placebo in patients with AF and ACS and/or PCI
You so the regimens of antibiotic therapy around patients who had a atrial fibrillation and acute coronary syndrome or undergo pci is a challenge because we need to combine anticoagulation therapy with antiplatelet therapy and there is a need to better understand those regimens so the august’s trial was designed to try to answer two questions one was a picc seban
Better than vk a vitamin k antagonist for these patients and two what is the row of aspirin is aspirin needed as part of the regimens in a patient population that is already using a pitch y12 enabler as a background like clopidogrel for example again to answer two questions in a single trial you have to do a 2×2 factorial design and that’s what we did so patients
With atrial fibrillation where oranga coagulation therapy was indicated and i also patient acute coronary syndrome or pci where a p12 anymore was indicated for at least six months so that’s our trial population we first randomized them to apixaban five milligrams twice daily which is they approved those for stroke prevention versus vk a vitamin k antagonist with a
Target inr between two and three so that was our first part of the trial you know first randomization factor this piece was open label but because was a 2×2 factorial design we also randomized patients to a spring or placebo in a double-blind fashion our primary endpoint was bleeding at six months so let’s start with the apixaban comparison we found that a picture
Been reduced the risk of bleeding by 31% highly statistically significant with a four point two percent relative risk reduction apixaban also reduced the risk of death or hospitalization by 17% highly statistically significant also primarily driven by all by a reduction in all cause hospitalization and when you look at death or ischemic events we do not find any
Difference between a pizza pan and vka although we did find a lower rate of stroke and hospitalization among patients treated with a fixed burn compared to patients receiving vka for the aspirin part of the trial will show that as we increase the risk of bleeding by 89% highly statistically significant an absolute increased risk of 7.1% compared to placebo when
We look at that or hospitalization we do not find any difference between a spree and placebo for death or hospitalization and we also did not find any significant difference on death or ischemic events between a spring and placebo and this was also the case for all the components of these chemic endpoints where we did not find any significant difference between
Placebo and aspirin so those were the key findings from the two comparisons that we did in our 2×2 factorial design trial there are several differences in the trial design the drugs are different the doses are different so is difficult to make a comparison but i think i will trial in a very robust way can i answer the question about a pixel ban and can answer the
Question about safety of aspirin in a very robust way and give us an additional piece a very important piece to this complex puzzle which is the antibiotic therapy combinations for patients with afib and acs and i think the message the main message or the main lesson learn is that in this clinical setting less might be more therefore an mg coagulant that is better
Than vka such as a pixel ban plus a pitch y12 a neighbor like clopidogrel might be enough for the majority of patients that had afib and acs or pci in in other words less is more we might not need asking for the majority of patients and then of course if you’re gonna have to use as before some specific reason we also learned and using a spring plus clopidogrel
With a noack in this case a pixel ban was better than using with a vka
Transcribed from video
ACC 2019: AUGUSTUS – Prof Renato D. Lopes By Radcliffe
