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Augustus loop license4/24/2023 Choice was hard because people with AF plus ACS “have been mainly excluded from trials as they are very high risk, they bleed a lot, and have a lot of ischaemic events.” Because of this, “guidelines have been largely driven by observational studies, consensus documents, and professional opinions the level of evidence is not high with a low level of certainty of suggestions.” Prof Lopes explained that there are potentially 2.8 million treatment options for people with AF and ACS and/or PCI. People did what they thought was best but without Conversely, for ACS, guidelines recommend dual antiplatelet therapy, but this isn’t as good as an OAC for reducing overall stroke risk.” Dr Vora discussed how triple antithrombotic therapy (VKA, P2Y 12i, and aspirin) has been the mainstay therapy for over 20 years, “despite data suggesting that bleeding risk is very high in these patients.” However, he said: “There was no good, meaningful way to study trade-offs. “The cornerstone of treatment for AF is to reduce risk of stroke with OAC therapy, but this is not sufficient to prevent recurrent ischaemic events in those with ACS or PCI. HOW HAVE GUIDELINES TRADITIONALLY ADDRESSED TREATMENT FOR THESE PATIENTS?Īs there are separate guidelines for those with AF and those with ACS, “this is a difficult population to treat,” explained Dr Vora. Prof Renato Lopes and Dr Amit Vora, clinical researchers involved in the trial, spoke with EMJ about how findings from AUGUSTUS are changing the landscape of prescribing for people with AF and ACS or/and PCI. 1 AUGUSTUS was the only major trial of its type to include ‘medically managed’ ACS patients, who did not receive a stent, as well as those undergoing PCI. In a 2×2 factorial design, participants received either the DOAC apixaban (n=2,306) or a VKA (n=2,308), and either aspirin (n=2,307) or a placebo (n=2,307), on background P2Y 12i therapy. Balancing therapy requirements can be difficult and has historically been little investigated.ĪUGUSTUS is, to date, the largest trial of treatment of nonvalvular AF with ACS and/or PCI. However, what if someone with AF also experiences ACS and/or needs PCI? Management of ACS and/or PCI typically requires antiplatelet therapy, such as with aspirin and a P2Y 12 inhibitor (P2Y 12i). The findings of AUGUSTUS, in combination with previous studies, are set to change guidelines and practice regarding the best treatment regimen for someone with AF with ACS and/or PCI.ĪF can increase stroke risk and is generally treated with OAC therapy, such as with a VKA or a direct OAC (DOAC). For those undergoing PCI, AUGUSTUS showed that aspirin may be useful in the first 30 days only. The main results of AUGUSTUS showed that the apixaban-based regimen was superior to a VKA-based strategy in terms of fewer hospitalisations and that, for many, as shown in earlier studies, addition of aspirin was unnecessary and potentially harmful, as evidenced by a lower number of bleeding incidents in the placebo aspirin group. Prof Renato Lopes and Dr Amit Vora, clinical researchers involved in AUGUSTUS, discuss here how findings from the trial are changing the landscape of prescribing for people with AF and ACS or/and PCI. The inclusion in the trial of those who were ‘medically managed,’ without PCI was another unique factor that helped tease out how real-world patients with AF may be treated if they have ACS. AUGUSTUS was the largest trial to date to investigate treatment of AF in those with ACS/PCI and was run with a unique 2×2 factorial design whereby participants were separately randomised to either the direct OAC medication apixaban or a vitamin K antagonist (VKA) and either aspirin or an aspirin placebo, all with a P2Y12 inhibitor. For someone with nonvalvular atrial fibrillation (AF), co-occurrence of acute coronary syndrome (ACS), or need for percutaneous coronary intervention (PCI) can bring treatment dilemmas due to the need for both oral anticoagulation (OAC) therapy for AF and antiplatelet therapy for ACS/PCI.
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