MedicalResearch.com Interview with:
Renato D. Lopes MD, MHS, PhD
Professor of Medicine
Division of Cardiology
Duke University Medical Center
Duke Clinical Research Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In patients with acute coronary syndromes (ACS), approximately 20% to 30% of those with nonvalvular atrial fibrillation (NVAF) have concomitant coronary artery disease (CAD), and 5 to 10% of patients who undergo PCI have NVAF. These patients often receive both antiplatelet therapy and oral anticoagulants; and how best to combine these agents to minimize bleeding risk without compromising protection against thrombosis is an important unanswered question.
Analysis of results for bleeding indicated no significant interaction between the two randomization factors permitting independent analysis of results for the two key comparisons. The first showed that apixaban was both non-inferior and significantly superior to VKA for the primary outcome with a 31% reduction in the relative risk for bleeding. Aspirin significantly increased the relative risk for bleeding versus placebo by 89%.
Results for the composite of death and hospitalization showed that apixaban resulted in a relative risk reduction of 17%, primarily driven by a reduction in all cause hospitalization. There was no significant difference between results for aspirin versus placebo for this outcome.
Analysis of the composite of death and ischemic events indicated no significant differences in results for apixaban versus VKA or aspirin versus placebo.
MedicalResearch.com: What should readers take away from your report?
Response: These results from AUGUSTUS showed that in patients with NVAF and recent ACS or PCI treated with a P2Y12 inhibitor, an antithrombotic regimen that included apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in ischemic events versus regimens that included a VKA, aspirin, or both.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future studies looking at different durations of antithrombotic regimens might further refine the treatment of this high risk group of patients.
MedicalResearch.com: Is there anything else you would like to add?
Response: For the majority of patients, if you look at the totality of data, one lesion learned that is now confirmed by AUGUSTUS is that less is more. … If we use a P2Y12 inhibitor with one of the NOACS at the right dose for stroke prevention in atrial fibrillation— in this case, apixaban 5mg twice daily— you have the safest strategy and you don’t seem to pay a high cost on ischemic events for omitting aspirin.
My disclosures are in the manuscript.
Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation
Renato D. Lopes, M.D., Ph.D., Gretchen Heizer, M.S., Ronald Aronson, M.D., Amit N. Vora, M.D., M.P.H., Tyler Massaro, Ph.D., Roxana Mehran, M.D., Shaun G. Goodman, M.D., Stephan Windecker, M.D., Harald Darius, M.D., Jia Li, Ph.D., Oleg Averkov, M.D., Ph.D., M. Cecilia Bahit, M.D., et al., for the AUGUSTUS Investigators*
March 17, 2019
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