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SHR Neuro Cancer Cardio Lipid Metab Microb

Connolly, SJ; Eikelboom, J; Joyner, C; Diener, HC; Hart, R; Golitsyn, S; Flaker, G; Avezum, A; Hohnloser, SH; Diaz, R; Talajic, M; Zhu, J; Pais, P; Budaj, A; Parkhomenko, A; Jansky, P; Commerford, P; Tan, RS; Sim, KH; Lewis, BS; Van Mieghem, W; Lip, GY; Kim, JH; Lanas-Zanetti, F; Gonzalez-Hermosillo, A; Dans, AL; Munawar, M; O'Donnell, M; Lawrence, J; Lewis, G; Afzal, R; Yusuf, S; AVERROES Steering Committee and Investigators.
Apixaban in patients with atrial fibrillation.
N Engl J Med. 2011; 364(9):806-817 Doi: 10.1056/NEJMoa1007432 [OPEN ACCESS]
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Study Group Members Med Uni Graz:: Heinzel Frank
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Abstract:: BACKGROUND: Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients. METHODS: In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mg per day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism. RESULTS: Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI], 0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P=0.07). There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P=0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups. CONCLUSIONS: In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00496769.).
Find related publications in this database (using NLM MeSH Indexing): Aged -; Aged, 80 and over -; Aspirin - adverse effects Aspirin - therapeutic use; Atrial Fibrillation - complications Atrial Fibrillation - drug therapy; Double-Blind Method -; Embolism - epidemiology Embolism - prevention and control; Factor Xa - antagonists and inhibitors; Female -; Fibrinolytic Agents - adverse effects Fibrinolytic Agents - therapeutic use; Hemorrhage - chemically induced; Humans -; Male -; Middle Aged -; Proportional Hazards Models -; Pyrazoles - adverse effects Pyrazoles - therapeutic use; Pyridones - adverse effects Pyridones - therapeutic use; Risk Factors -; Stroke - epidemiology Stroke - prevention and control