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Dr. Marc Ferrini
What is the risk/benefit ratio of the association of an oral anticoagulation (OAC) with a double antiplatelet therapy (DAPT)? AUGUSTUS (presented at the ACC Congress on March, 18, 2019) brings new data.
AUGUSTUS was a prospective, multicenter, two-by-two factorial, randomized clinical trial, supported by the pharmaceutic industry, including 4614 patients with atrial fibrillation who had a recent acute coronary syndrome (ACS) and/or underwent PCI with stent, all of them on a P2Y12 inhibitor (Clopidogrel in most of the cases) with a 6 months follow up. (1)
The primary “safety” outcome was major or clinically relevant non major (CNRM) bleeding on International Society on Thrombosis and Haemostasis (ISTH) criteria.
Secondary outcomes included death or hospitalization and a composite of ischemic events.
The protocol allowed two independent hypothesis to be investigated:
Patients in the apixaban group had a lower incidence of death or hospitalization than those in the vitamin K antagonist group: 23.5% vs. 27.4% (HR 0.83; 95% CI, 0.74 to 0.93; P = 0.002), essentially driven by less hospitalisations. No difference in death or hospitalization at 6 months was noted between patients receiving aspirin and those receiving placebo.
At 6 months, there was no difference with regards to death or ischemic events (myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization) in the different groups: 154 events versus 163 in the apixaban as compared with the vitamin K antagonist group; 149 events versus 168 in the aspirin as compared with the placebo group.
The event rate per 100 patient-years for stroke was lower among patients receiving apixaban than among those receiving a vitamin K antagonist (hazard ratio, 0.50; 95% CI, 0.26 to 0.97)
Although the trial was not adequately powered to assess differences in individual ischemic outcomes, a greater number of coronary ischemic events among patients who did not take aspirin than among those who did was observed (stent thrombosis: 21 vs 11, myocardial infarction 84 vs 68, urgent revascularization 47 vs 37).
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