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BACKGROUND: Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear.
METHODS: In an international trial with a two-by-two factorial design, we randomly assigned patients with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y12 inhibitor to receive apixaban or a vitamin K antagonist and to receive aspirin or matching placebo for 6 months. The primary outcome was major or clinically relevant nonmajor bleeding. Secondary outcomes included death or hospitalization and a composite of ischemic events.
RESULTS: Enrollment included 4614 patients from 33 countries. There were no significant interactions between the two randomization factors on the primary or secondary outcomes. Major or clinically relevant nonmajor bleeding was noted in 10.5% of the patients receiving apixaban, as compared with 14.7% of those receiving a vitamin K antagonist (hazard ratio, 0.69; 95% confidence interval [CI], 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% of the patients receiving aspirin, as compared with 9.0% of those receiving placebo (hazard ratio, 1.89; 95% CI, 1.59 to 2.24; P<0.001). 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%; hazard ratio, 0.83; 95% CI, 0.74 to 0.93; P = 0.002) and a similar incidence of ischemic events. Patients in the aspirin group had an incidence of death or hospitalization and of ischemic events that was similar to that in the placebo group.
CONCLUSIONS: In patients with atrial fibrillation and a recent acute coronary syndrome 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 the incidence of ischemic events than regimens that included a vitamin K antagonist, aspirin, or both. (Funded by Bristol-Myers Squibb and Pfizer; AUGUSTUS ClinicalTrials.gov number, NCT02415400.).
|Family Medicine (FM)/General Practice (GP)|
|General Internal Medicine-Primary Care(US)|
The AUGUSTUS trial demonstrated that patients with atrial fibrillation who had needed treatment with P2Y12 inhibitors for a recent acute coronary syndrome and/or PCI, treatment with apixaban without aspirin resulted in lower incidence of major or clinically relevant non-major bleeding than regimens that included vitamin K antagonist, aspirin, or both. However, the trial was not powered to draw a conclusion regarding the observed higher number of coronary ischemic events among patients who did not receive aspirin compared with those who did. Overall, combined with previous trials, it provides compelling data favoring the routine use of direct oral anticoagulants without aspirin among patients with atrial fibrillation who also need treatment with a P2Y12 inhibitor for a recent acute coronary syndrome and/or PCI. However, this approach should be weighed against a potential increased risk for ischemic events with the omission of aspirin. Shared decision-making should guide clinical practice.
May be of more interest to cardiologists, but this trial is very helpful for how to manage CAD patients post-stent who also have afib, which is not uncommon.
This is an elegant study of anticoagulation in the setting of afib and ACS or PCI, a common and unresolved clinical question. The trial is of a two-by-two factorial design to receive apixaban OR a vitamin K antagonist with aspirin or placebo for 6 months. "Apixaban, without aspirin, resulted in less bleeding and fewer hospitalizations without significant differences in the incidence of ischemic events." This has immediate application to clinical practice.
This well done industry-funded study clarifies the approach to take after PCI or ACS in patients with afib: apixiban plus clopidogrel. Less bleeding and no difference in ischemic end points when compared with a VKA with or without aspirin.
Adds to the evidence that DOACs are preferable to warfarin, and that "triple" therapy is unnecessarily toxic.
Another useful contribution to the very active question about which cardiovascular patients benefit from aspirin, particularly to the uncertainties surrounding aspirin for patients with an indication (recent CV event), AND already on NOACs for a sound reason. Unfortunately, the warfarin arm must be mostly rejected from contemplation because, once again (as with EINSTEIN, RELY, HOKUSAI), the warfarin "comparison" was POORLY DONE, using warfarin instead of optimal warfarin (TTR well below what can be achieved at a robust modern anticoagulation clinic, and therefore not the meaningful "real world" comparison the authors claim it to be). On balance, another in an emerging list of when to likely NOT use aspirin, a reversal of decades of received wisdom.