BACKGROUND: ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation) demonstrated that apixaban, compared with aspirin, significantly reduced stroke and systemic embolism (SE) but increased major bleeding in patients with subclinical atrial fibrillation. OBJECTIVES: To help inform decision making, the authors evaluated the efficacy and safety of apixaban according to baseline CHA2DS2-VASc score. METHODS: We performed a subgroup analysis according to baseline CHA2DS2-VASc score and assessed both the relative and absolute differences in stroke/SE and major bleeding. RESULTS: Baseline CHA2DS2-VASc scores were <4 in 1,578 (39.4%) patients, 4 in 1,349 (33.6%), and >4 in 1,085 (27.0%). For patients with CHA2DS2-VASc >4, the rate of stroke was 0.98%/year with apixaban and 2.25%/year with aspirin; compared with aspirin, apixaban prevented 1.28 (95% CI: 0.43-2.12) strokes/SE per 100 patient-years and caused 0.68 (95% CI: -0.23 to 1.57) major bleeds. For CHA2DS2-VASc <4, the stroke/SE rate was 0.85%/year with apixaban and 0.97%/year with aspirin. Apixaban prevented 0.12 (95% CI: -0.38 to 0.62) strokes/SE per 100 patient-years and caused 0.33 (95% CI: -0.27 to 0.92) major bleeds. For patients with CHA2DS2-VASc =4, apixaban prevented 0.32 (95% CI: -0.16 to 0.79) strokes/SE per 100 patient-years and caused 0.28 (95% CI: -0.30 to 0.86) major bleeds. CONCLUSIONS: One in 4 patients in ARTESiA with subclinical atrial fibrillation had a CHA2DS2-VASc score >4 and a stroke/SE risk of 2.2% per year. For these patients, the benefits of treatment with apixaban in preventing stroke/SE are greater than the risks. The opposite is true for patients with CHA2DS2-VASc score <4. A substantial intermediate group (CHA2DS2-VASc =4) exists in which patient preferences will inform treatment decisions. (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; NCT01938248).

Amphia Ziekenhuis Breda the Netherlands

Cardiology and Vascular Disease Division Rennes University Health Centre Rennes France

Cardiology Department Hospital Universitario La Luz Madrid Spain

Cardiology Division Department of Biomedical Metabolic and Neural Sciences University of Modena and Reggio Emilia Policlinico di Modena Modena Italy

Cliniques du Sud Luxembourg Department of Cardiology Arlon Belgium

Department of Cardiology Central Hospital of Northern Pest Military Hospital and Heart and Vascular Center Semmelweis University Budapest Hungary

Department of Cardiology Montreal Heart Institute Université de Montréal Montreal Quebec Canada

Department of Cardiology University Hospital Basel University of Basel Basel Switzerland

Department of Cardiology Western University London Ontario Canada

Department of Clinical Medicine Aarhus University and Department of Cardiology Aarhus University Hospital Aarhus Denmark

Department of Medicine Medical University of South Carolina Charleston South Carolina USA

Division of Cardiology Oslo University Hospital Ulleval and Institute of Clinical Medicine University of Oslo Oslo Norway

Duke Clinical Research Institute Duke University School of Medicine Durham North Carolina USA

Institute for Clinical and Experimental Medicine Prague Czech Republic

J W Goethe University Frankfurt Germany

Karolinska Institutet Stockholm Sweden

McMaster University Hamilton Health Sciences Hamilton Ontario Canada

Population Health Research Institute McMaster University Hamilton Ontario Canada

Population Health Research Institute McMaster University Hamilton Ontario Canada; Department of Cardiology University Medical Center Mainz Johannes Gutenberg University Mainz Germany

School of Medicine and Dentistry University of Rochester Rochester New York USA

St Mary's Regional Cardiac Center Kitchener Ontario Canada

University of Ottawa Heart Institute Ottawa Ontario Canada

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ClinicalTrials.gov
NCT01938248