Stroke Risk and Treatment in Patients with Atrial Fibrillation and Low CHA2DS2-VASc Scores: Findings From the ORBIT-AF I and II Registries.
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2018-08
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Background Current American College of Cardiology/American Heart Association guidelines suggest that for patients with atrial fibrillation who are at low risk for stroke (CHA2DS2VASc=1) (or women with CHA2DS2VASc=2) a variety of treatment strategies may be considered. However, in clinical practice, patterns of treatment in these "low-risk" patients are not well described. The objective of this analysis is to define thromboembolic event rates and to describe treatment patterns in patients with low-risk CHA2DS2VASc scores. Methods and Results We compared characteristics, treatment strategies, and outcomes among patients with a CHA2DS2VASc=0, CHA2DS2VASc=1, females with a CHA2DS2VASc=2, and CHA2DS2VASc ≥2 in ORBIT-AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) I & II. Compared with CHA2DS2VASc ≥2 patients (84.2%), those with a CHA2DS2VASc=0 (60.3%), 1 (69.9%), and females with a CHA2DS2VASc score=2 (72.4%) were significantly less often treated with oral anticoagulation ( P<0.0001). Stroke rates were low overall and ranged from 0 per 100 patient-years in those with CHA2DS2VASc=0, 0.8 (95% confidence interval [CI] [0.5-1.2]) in those with CHA2DS2VASc=1, 0.8 (95% CI [0.4-1.6]) in females with a CHA2DS2VASc score=2, and 1.7 (95% CI [1.6-1.9]) in CHA2DS2VASc ≥2. All-cause mortality (per 100 patient-years) was highest in females with a CHA2DS2VASc score=2 (1.4) (95% CI [0.8-2.3]), compared with patients with a CHA2DS2VASc=0 (0.2) (95% CI [0.1-1.0]), and CHA2DS2VASc=1 (1.0) (95% CI [0.7-1.4]), but lower than patients with a CHA2DS2VASc ≥2 (5.7) (95% CI [5.4-6.0]). Conclusion The majority of CHA2DS2VASc=0-1 patients are treated with oral anticoagulation. In addition, the absolute risks of death and stroke/transient ischemic attack were low among both male and females CHA2DS2VASc=0-1 as well as among females with a CHA2DS2VASc score=2. Clinical Trial Registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT01701817.
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Jackson, Larry R, Sunghee Kim, Gregg C Fonarow, James V Freeman, Bernard J Gersh, Alan S Go, Elaine M Hylek, Peter R Kowey, et al. (2018). Stroke Risk and Treatment in Patients with Atrial Fibrillation and Low CHA2DS2-VASc Scores: Findings From the ORBIT-AF I and II Registries. Journal of the American Heart Association, 7(16). p. e008764. 10.1161/jaha.118.008764 Retrieved from https://hdl.handle.net/10161/17832.
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Larry Ronald Jackson
Dr. Jackson is a physician-scientist with clinical expertise in adult clinical cardiac electrophysiology. His research focuses on identifying determinants of racial/ethnic differences in arrhythmia care and the development and implementation of patient-centered interventions aimed at facilitating shared decision-making in populations that have been systemically disadvantaged with abnormal heart rhythm conditions. Dr. Jackson has an advanced degree (MHSc) in clinical and qualitative research methodology and is a member of the Duke Clinical Research Institute. His research skills, obtained during his time at the Duke Clinical Research Institute Research Fellowship, include formal training in large database analysis, clinical trial operations, scientific writing, clinical trial adjudication and statistical analysis. Dr. Jackson’s research funding consists of two career development awards: 1) National Institute of Health/National Heart, Lung, and Blood Institute-K01 focused on racial and ethnic differences in oral anticoagulation use in patients with atrial fibrillation and 2) AHA career development award focused on analyzing racial and ethnic differences in the use of rhythm control strategies in patients with atrial fibrillation. Dr. Jackson’s long-term, overarching goal as a physician-scientist is to decrease racial and ethnic disparities in arrhythmia care for patients with abnormal heart rhythm conditions.
Laine Elliott Thomas
Laine Thomas, PhD, joined the Department of Biostatistics and Bioinformatics and DCRI in 2009. She serves as Associate Chair for Equity, Diversity and Inclusion within the Department of Biostatistics and Bioinformatics and Deputy Director of Data Science and Biostatistics at the Duke Clinical Research Institute. She is a leader in study design and development of methods for observational and pragmatic studies, with over 240 peer reviewed clinical and methodological publications arising from scientific collaboration in the therapeutic areas of cardiovascular disease, diabetes, uterine fibroids and SARS-CoV-2 virus. She led the statistical teams on the HERO COVID-19, ORBIT-AF I & II, ACTION-CMS, CHAMP-HF, and COMPARE-UF clinical registries and secondary analyses of the NAVIGATOR and ARISTOTLE clinical trials. She has served as a primary investigator and co-investigator on numerous methodological studies with funding from NIH, AHRQ, PCORI and Burroughs Wellcome Fund, addressing observational treatment comparisons, time-varying treatments, heterogeneity of treatment effects, and randomized trials augmented by synthetic controls from real world data.
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