For patients with atrial fibrillation and a recent acute coronary syndrome or percutaneous coronary intervention (PCI) treated with a P2Y12 inhibitor, a regimen including apixaban without aspirin can reduce bleeding and hospitalizations, according to results published in the New England Journal of Medicine. The results indicated that the incidence of ischemic events for this regimen was not significantly different compared with regimens that included a vitamin K agonist, aspirin, or both.
This international trial with a two-by-two factorial design included 4614 participants with atrial fibrillation who had an acute coronary syndrome or had undergone PCI and were planning to take a P2Y12 inhibitor (ClinicalTrials.gov identifier: NCT02415400). Participants were randomly assigned to apixaban or a vitamin K agonist and to aspirin or matching placebo for 6 months. The primary outcome was major or clinically-relevant nonmajor bleeding. Secondary outcomes were death or hospitalization and a composite of ischemic events.
Among participants receiving apixaban, 10.5% (241 of 2290) experienced major or clinically relevant nonmajor bleeding compared with 14.7% (332 of 2259) of those receiving a vitamin K antagonist (hazard ratio [HR], 0.69; 95% CI, 0.58-0.81; P <.001). Among participants receiving aspirin, 16.1% (367 of 2277) experienced bleeding compared with 9.0% (204 of 2279) of those receiving placebo (HR, 1.89; 95% CI, 1.59-2.24; P <.001).
The incidence of death or hospitalization among participants receiving apixaban was 23.5% (541 of 2306) compared with 27.4% (632 of 2308) for those in the vitamin K antagonist group (HR, 0.83; 95% CI, 0.74-0.93; P =.002). Both groups had similar rates of ischemic events.
The incidence of death or hospitalization and of ischemic events was similar among participants receiving aspirin and those receiving placebo.
“A regimen of clopidogrel plus apixaban, at the dose labeled for stroke prevention, without aspirin was not associated with excess adverse events and appeared to be effective in this high-risk group of patients,” wrote the researchers.
Disclosure: Bristol-Myers Squibb and Pfizer funded this study.
Lopes RD, Heizer G, Aronson R, et al; AUGUSTUS Investigators. Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation. N Engl J Med. 2019;380(16):1509-1524.