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SHR Neuro Krebs Kardio Lipid Stoffw Microb

Lopes, RD; Heizer, G; Aronson, R; Vora, AN; Massaro, T; Mehran, R; Goodman, SG; Windecker, S; Darius, H; Li, J; Averkov, O; Bahit, MC; Berwanger, O; Budaj, A; Hijazi, Z; Parkhomenko, A; Sinnaeve, P; Storey, RF; Thiele, H; Vinereanu, D; Granger, CB; Alexander, JH; AUGUSTUS Investigators.
Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation.
N Engl J Med. 2019; 380(16): 1509-1524. Doi: 10.1056/NEJMoa1817083 [OPEN ACCESS]
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Scherr Daniel
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Abstract:
Appropriate antithrombotic regimens for patients with atrial fibrillation who have an acute coronary syndrome or have undergone percutaneous coronary intervention (PCI) are unclear. 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. 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. 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.). Copyright © 2019 Massachusetts Medical Society.
Find related publications in this database (using NLM MeSH Indexing)
Acute Coronary Syndrome - complications
Acute Coronary Syndrome - therapy
Aged -
Aged, 80 and over -
Anticoagulants - adverse effects
Anticoagulants - therapeutic use
Aspirin - adverse effects
Aspirin - therapeutic use
Atrial Fibrillation - complications
Atrial Fibrillation - drug therapy
Double-Blind Method -
Drug Therapy, Combination -
Factor Xa Inhibitors - adverse effects
Factor Xa Inhibitors - therapeutic use
Female -
Hemorrhage - chemically induced
Humans -
Male -
Middle Aged -
Percutaneous Coronary Intervention -
Platelet Aggregation Inhibitors - therapeutic use
Purinergic P2Y Receptor Antagonists - therapeutic use
Pyrazoles - adverse effects
Pyrazoles - therapeutic use
Pyridones - adverse effects
Pyridones - therapeutic use
Vitamin K - antagonists & inhibitors

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