BACKGROUND: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. METHODS: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. RESULTS: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction=0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; Pinteraction=0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction=0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=0.710). CONCLUSIONS: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.

Bristol Myers Squibb Lawrenceville NJ

Canadian VIGOUR Center University of Alberta Edmonton Canada

Cardiovascular Clinical Research Institute Lady Davis Carmel Medical Center Haifa Israel

Charles University Prague Czech Republic

Clinical Centre of Serbia Belgrade

Concord Clinical School ANZAC Research Institute University of Sydney Australia

CONEVID School of Medicine Universidad Peruana Cayetano Heredia Lima Peru

Department of Cardiology Inselspital Bern University Hospital University of Bern Switzerland

Duke Clinical Research Institute Duke University School of Medicine Durham NC

EA3920 University of Burgundy Franche Comté Besançon France

German Center for Cardiovascular Research

Hospital Central Dr Ignacio Morones Prieto San Luis Potosi Mexico

Hospital de Santo André Leiria Portugal

Instituto Cardiovascular de Buenos Aires and Sanatorio Anchorena Argentina

Mazankowski Alberta Heart Institute Edmonton Canada

National Institute of Cardiovascular Diseases Bratislava Slovakia

Oslo University Hospital Ulleval University of Oslo Norway

Rigshospital University of Copenhagen Denmark

School of Medicine Belgrade University Serbia

Semmelweis University Heart and Vascular Center Budapest Hungary

Seoul National University Hospital Seoul National University Korea

St John's Medical College and Research Institute Bangalore India

Terrence Donnelly Heart Centre St Michael's Hospital University of Toronto Ontario Canada

University Heart Centre Lübeck University Hospital Schleswig Holstein Germany

University Hospital Jean Minjoz Besançon France

University Hospital St Anna Sofia Bulgaria

University of Zagreb School of Medicine University Hospital Centre Croatia

Vivantes Neukoelln Medical Center Berlin Germany

Wilhelminenhospital and Sigmund Freud University Medical School Vienna Austria

Zena and Michael A Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai and Cardiovascular Research Foundation New York NY

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ClinicalTrials.gov
NCT02415400