1. Apixaban vs Aspirin According to CHA 2 DS 2 -VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA.
- Author
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Lopes RD, Granger CB, Wojdyla DM, McIntyre WF, Alings M, Mani T, Ramasundarahettige C, Rivard L, Atar D, Birnie DH, Boriani G, Amit G, Leong-Sit P, Rinne C, Duray GZ, Gold MR, Hohnloser SH, Kutyifa V, Benezet-Mazuecos J, Cosedis Nielsen J, Sticherling C, Benz AP, Linde C, Kautzner J, Mabo P, Mairesse GH, Connolly SJ, and Healey JS
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Risk Assessment methods, Hemorrhage chemically induced, Hemorrhage epidemiology, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Pyrazoles therapeutic use, Pyridones therapeutic use, Pyridones adverse effects, Pyridones administration & dosage, Aspirin therapeutic use, Stroke prevention & control, Stroke etiology, Stroke epidemiology, Factor Xa Inhibitors therapeutic use
- 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 DS2 -VASc score., Methods: We performed a subgroup analysis according to baseline CHA2 DS2 -VASc score and assessed both the relative and absolute differences in stroke/SE and major bleeding., Results: Baseline CHA2 DS2 -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 CHA2 DS2 -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 CHA2 DS2 -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 CHA2 DS2 -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 CHA2 DS2 -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 CHA2 DS2 -VASc score <4. A substantial intermediate group (CHA2 DS2 -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)., Competing Interests: Funding Support and Author Disclosures The ARTESiA study was funded by grants from the Canadian Institutes of Health Research (201610PTJ-378238), the Bristol Myers Squibb–Pfizer Alliance, the Heart and Stroke Foundation of Canada, the Canadian Stroke Prevention Intervention Network, Hamilton Health Sciences, the Accelerating Clinical Trials Network, the Population Health Research Institute, and Medtronic. The sponsors had no role in data analysis, interpretation, or publication. Dr Lopes has received research grants from Amgen, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Medtronic, Novo Nordisk, Pfizer, and Sanofi US Services Inc; and has served as a consultant to Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo Company, GlaxoSmithKline, Medtronic, Merck, Novo Nordisk, Pfizer, Portola Pharmaceuticals, and Sanofi US Services Inc. Dr Granger has received research grants from Bayer and Boehringer Ingelheim; and has served as a consultant to Anthos, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific Corporation, Bristol Myers Squibb, Cadrenal, Daiichi-Sankyo Company, Janssen Global Services, LLC, Merck, Pfizer Inc, and Tenac.io. Dr McIntyre has served as a consultant to Servier Pharmaceuticals LLC. Dr Rivard has received research grants from Bayer Inc, Heart and Stroke Foundation, Canadian Institutes of Health Research (CIHR), and FRQS (Fonds de Recherche Quebec-Sante). Dr Atar has received speaker fees from Amgen, Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Philips, Roche Diagnostics, Sanofi, Takeda, and Vifor; and has received institutional grant support from Bristol Myers Squibb/Pfizer, Medtronic, Bayer, and Roche Diagnostics. Dr Boriani has received speaker fees from Bayer, Boston Scientific, Boehringer Ingelheim, Daiichi-Sankyo, Janssen, and Sanofi. Dr Duray has served as a consultant to Medtronic and Biotronik. Dr Gold has received institutional research support from Abbott, Boston Scientific, and Medtronic; and has received consulting fees from Boston Scientific and Medtronic. Dr Hohnloser has served as a consultant to Pfizer, Bristol Myers Squibb, Boehringer Ingelheim, and Sanofi. Dr Kutyifa has received research grants from Boston Scientific, ZOLL, National Institutes of Health, and Spire Inc; has received speaker fees from Medtronic, Abbott, and Biotronik; and has received consultant fees from Biotronik. Dr Sticherling has served as a consultant to Medtronic, Boston Scientific, and Biotronik. Dr Benz has received lecture fees from Bristol Myers Squibb and AstraZeneca; and has participated in an educational program supported by Boston Scientific (“Fellowship Herzrhythmus”). Dr Linde has received research support from the Swedish Heart Lung Foundation, Swedish Royal Society of Science, and Stockholm County Council; has received consulting fees from AstraZeneca and Roche Diagnostics; has received speaker honoraria from Novartis, AstraZeneca, Bayer, Vifor Pharma, Medtronic, and Impulse Dynamics; and has served on advisory boards for Astra Zeneca. Dr Kautzner has served as a consultant for Abbott Vascular, Biotronik, Boston Scientific Corporation, GE Healthcare, and Medtronic, Inc. Dr Mairesse has received consultant or speaker fees from Abbott, Biotronik, Microport, Bristol Myers Squibb/Pfizer, and Daiichi-Sankyo. Dr Connolly has received research grants from Pfizer Inc; and has served as a consultant for Bayer, Bristol Myers Squibb, Daiichi-Sankyo Company, and Javelin Ventures. Dr Healey has received research grants from Boston Scientific Corporation, Bristol Myers Squibb, Medtronic, and Pfizer; has served as a consultant for Bayer, Boston Scientific Corporation, Medtronic, Novartis, and Servier Affaires Medicales; and has served as an expert witness for Bayer., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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