Year: 2024
Type: article
Abstract: 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 CHA 2 DS 2 -VASc score. Methods We performed a subgroup analysis according to baseline CHA 2 DS 2 -VASc score and assessed both the relative and absolute differences in stroke/SE and major bleeding. Results Baseline CHA 2 DS 2 -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 CHA 2 DS 2 -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 CHA 2 DS 2 -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 CHA 2 DS 2 -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 CHA 2 DS 2 -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 CHA 2 DS 2 -VASc score <4. A substantial intermediate group (CHA 2 DS 2 -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 )
Authors: Renato D. Lopes, Christopher B. Granger, Daniel M. Wojdyla, William F. McIntyre, Marco Alings, Thenmozhi Mani, Chinthanie Ramasundarahettige, Lena Rivard, Dan Atar, David H. Birnie, Giuseppe Boriani, Guy Amit, Peter Leong-Sit, Claus Rinne, Gabor Z. Duray, Michael R. Gold, Stefan H. Hohnloser, Valentina Kutyifa, Juan Benezet-Mazuecos, Jens Cosedis Nielsen, Christian Sticherling, Alexander P. Benz, Cecilia Linde, Joseph Kautzner, Philippe Mabo, Georges H. Mairesse, Stuart J. Connolly, Jeff S. Healey
Institutions: Duke University, Duke Clinical Research Institute, Population Health Research Institute, McMaster University, Amphia Ziekenhuis, Montreal Heart Institute, Université de Montréal, Oslo University Hospital, University of Oslo, University of Ottawa, Ottawa Heart Institute, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria di Modena, Hamilton Health Sciences, Western University, Semmelweis University, Medical University of South Carolina, Goethe University Frankfurt, University of Rochester Medicine, University of Rochester, Hospital La Luz, Aarhus University, Aarhus University Hospital, University of Basel, University Hospital of Basel, Johannes Gutenberg University Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Karolinska Institutet, Institute of Clinical and Experimental Medicine, Laboratoire Traitement du Signal et de l'Image, Hôpital Pontchaillou, Centre Hospitalier Universitaire de Rennes, Cliniques du Sud Luxembourg
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: Amgen, Bristol-Myers Squibb, Pfizer, AstraZeneca, GlaxoSmithKline, Sanofi, Heart and Stroke Foundation of Canada, Hamilton Health Sciences, Boston Scientific Corporation, Amarin Corporation, ZOLL Medical Corporation, Impulse Dynamics, Daiichi-Sankyo, Novo Nordisk, Stockholms Läns Landsting, Vifor Pharma, National Institutes of Health, Bayer Canada, Canadian Institutes of Health Research, Fonds de Recherche du Québec - Santé, Daiichi Sankyo Company, Daiichi Sankyo Europe
OpenAlex ID: W4397289079