scholarly journals Effectiveness and Safety of Standard-Dose Nonvitamin K Antagonist Oral Anticoagulants and Warfarin Among Patients With Atrial Fibrillation With a Single Stroke Risk Factor

2017 ◽  
Vol 2 (8) ◽  
pp. 872 ◽  
Author(s):  
Gregory Y. H. Lip ◽  
Flemming Skjøth ◽  
Peter Brønnum Nielsen ◽  
Jette Nordstrøm Kjældgaard ◽  
Torben Bjerregaard Larsen
2018 ◽  
Vol 5 (2) ◽  
pp. 64-69 ◽  
Author(s):  
Craig I Coleman ◽  
Alexander G G Turpie ◽  
Thomas J Bunz ◽  
Daniel Eriksson ◽  
Nitesh A Sood ◽  
...  

Abstract Aims To compare the effectiveness and safety of standard-dose rivaroxaban (20 mg o.d.) and warfarin in non-valvular atrial fibrillation (NVAF) patients with a non-sex-related CHA2DS2-VASc score of 1. Methods and results Analysis of United States Truven MarketScan claims from November 2011 to December 2016 for anticoagulant-naïve NVAF patients with a single non-sex-related stroke risk factor assigned 1-point in the CHA2DS2-VASc score and ≥12-months of continuous medical/prescription insurance coverage prior to the qualifying oral anticoagulant dispensing. Standard-dose rivaroxaban users were 1:1 propensity score-matched to warfarin users. Patients were followed until outcome occurrence, insurance disenrollment, or end of data availability. Primary outcomes included stroke or systemic embolism and major bleeding and were compared using Cox regression and reported as hazard ratios (HRs) with 95% confidence intervals (CIs). In all, 3319 rivaroxaban users were 1:1 propensity score-matched to 3319 warfarin users. Median (interquartile range) duration of follow-up was 1.6 (0.7, 2) years and the most common qualifying stroke risk factor was hypertension (n = 4532, 68.3%). Rivaroxaban was associated with a significant reduction in the 1-year stroke or systemic embolism vs. warfarin (HR 0.41, 95% CI 0.17–0.98), with no significant difference in overall major bleeding (HR 0.74, 95% CI 0.44–1.26) or major bleeding subtypes (HR ranging from 0.33 to 0.78, P > 0.05 for all). Similar results were seen after extending follow-up to 2 years. Conclusions Rivaroxaban may lower the rate of stroke or systemic embolism vs. warfarin in NVAF patients with a non-sex-related CHA2DS2-VASc score of 1 without impacting major bleeding.


Open Heart ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e001465
Author(s):  
Maxim Grymonprez ◽  
Stephane Steurbaut ◽  
An De Sutter ◽  
Lies Lahousse

AimsOral anticoagulants (OACs) are crucial for treating atrial fibrillation (AF) patients at high thromboembolic risk. However, in AF patients at intermediate thromboembolic risk with a single non-sex-related stroke risk factor (CHA2DS2-VASc score 1 in men, 2 in women), guidelines advise to consider starting anticoagulation, which may result in OAC non-initiation due to underestimation of the thromboembolic risk of a single stroke risk factor and overestimation of the OAC-related bleeding risk. A critical appraisal of the role of OACs and the benefit–risk profile of non-vitamin K antagonist oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) in this patient subgroup are needed.Methods and resultsThis systematic review provides an overview of literature on the effectiveness and safety of OACs in AF patients with a single non-sex-related stroke risk factor after searching Medline and Embase. Differences between individual stroke risk factors regarding the ischaemic stroke risk in non-anticoagulated AF patients are identified in a meta-analysis, demonstrating the highest increased risk in patients aged 65–74 years old or with diabetes mellitus, followed by heart failure, hypertension and vascular disease. Furthermore, meta-analysis results favour NOACs over VKAs, given their equal effectiveness and superior safety in AF patients at intermediate thromboembolic risk (HR 0.93, 95% CI 0.65 to 1.34 for stroke or systemic embolism; HR 0.60, 95% CI 0.45 to 0.80 for major bleeding; HR 0.48, 95% CI 0.14 to 1.59 for intracranial bleeding; HR 0.58, 95% CI 0.47 to 0.71 for mortality).ConclusionOur systematic review with meta-analysis favours the use of anticoagulation in AF patients with a single non-sex-related stroke risk factor, especially when age ≥65 years or diabetes mellitus is present, with a preference for NOACs over VKAs.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Mariacarla Gallù ◽  
Giulia Marrone ◽  
Jacopo Maria Legramante ◽  
Antonino De Lorenzo ◽  
Nicola Di Daniele ◽  
...  

Sex-specific differences have been definitively demonstrated in cardiovascular (CV) diseases. These differences can also impact on the effects of CV therapies. Female sex is recognized as an independent predictor of thromboembolic risk, particularly in older patients. Most of strokes are due to atrial fibrillation (AF). Women affected by AF have higher stroke risk compared to men. The introduction of novel oral anticoagulants (NOACs) for long-term anticoagulation completely changed the anticoagulant therapeutic approach and follow-up of patients affected by nonvalvular atrial fibrillation (NVAF). CHA2DS2-VASc stroke risk scoring in use in the current international guidelines attributes 1 point to “female sex”. Besides, no anticoagulation is indicated for AF female patients without other risk factors. Interestingly, NOACs seem to normalize the differences between males and females both in terms of safety and efficacy, whereas residual higher stroke risk and systemic embolism persist in AF women treated with vitamin K antagonist anticoagulants VKA with optimal time in therapeutic range. Based on the CHA2DS2-VASc score, NOACs represent the preferred choice in NVAF patients. Moreover, complete evaluation of apparently lower risk factor along with concomitant clinical conditions in AF patients appears mandatory, particularly for female patients, in order to achieve the most appropriate anticoagulant treatment, either in male or in female patients. The present review was performed to review sex differences in AF-related thromboembolic risk reported in the literature and possibly highlight current knowledge gaps in prevention and management that need further research.


Heart ◽  
2019 ◽  
Vol 106 (7) ◽  
pp. 534-540 ◽  
Author(s):  
Victor Chien-Chia Wu ◽  
Michael Wu ◽  
Victor Aboyans ◽  
Shang-Hung Chang ◽  
Shao-Wei Chen ◽  
...  

ObjectivesFemale sex is an inconsistent ischaemic stroke risk factor in patients with atrial fibrillation (AF). We hypothesised that the ischaemic stroke risk varies with age among women compared with men.MethodsWe retrieved the patients with newly diagnosed AF during 2001–2013 from Taiwan’s National Health Insurance Research Database. Patients with missing information, age <20 years, history of valvular heart disease and surgery, rheumatic heart disease, hyperthyroidism or anticoagulation and/or antiplatelet use were excluded. Propensity score matching (PSM) included patient comorbidities, medications and index date stratified by age and sex groups. Primary outcome was defined as ischaemic stroke at follow-up.ResultsAfter exclusion criteria, 87 369 men and 71 853 women remained for analysis (aged 73.1±14.4 years). After 1:1 PSM, we included 59 583 men (aged 73.5±13.7 years) and 59 583 women (aged 73.4±13.8 years) for analysis. We also stratified patients by age. The ischaemic stroke risk varied with age in women compared with men: lower in the ≤55 years (subdistribution HR (SHR)=0.75, 95% CI 0.62 to 0.90) and 56–65 years (SHR=0.87, 95% CI 0.78 to 0.98) groups, neutral in the 66–75 years group (SHR=1.01, 95% CI 0.94 to 1.08) and adverse in the >75 years group (SHR=1.14, 95% CI 1.09 to 1.19).ConclusionsThe female/male ischaemic stroke risk ratio varied with age. Only women aged >75 years had a higher risk, whereas women aged <65 years had a lower risk compared with men. These findings challenge the ‘sex category’ component of the CHA2DS2-VASc score, used to make decision regarding anticoagulation treatment in AF patients.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Stephanie Paolini ◽  
Roxanne D Poole ◽  
Kelly Hawsey ◽  
Blease C Graham ◽  
Souvik Sen

Introduction: In acute ischemic stroke (AIS), intravenous tissue plasminogen activator (IV TPA), if administered appropriately can be beneficial; however, with stroke misdiagnosis, it can expose patients to unnecessary bleeding risks. Thus, accurate diagnosis is critical. Brain Magnetic Resonance Imaging (MRI) is sensitive to detect AIS; however, a complete exam may consume 30-45 minutes. At the University of South Carolina Palmetto Health Richland Stroke Center, an ultra-rapid, 10 minute MRI called the Brain Attack Team MRI (BAT MRI) was designed to accurately and expeditiously diagnose AIS. Hypothesis: BAT MRI is a useful clinical tool to select or exclude patients for IV TPA who present acutely with stroke-like symptoms. Clinical correlates are not an effective substitution for BAT MRI to confirm AIS. Methods: In an ongoing study, conducted in 2010-11, 31 consecutive patients were identified who presented <4.5 hours from symptom onset and received a BAT MRI. They were 43-90 years in age; 48.4% White, 48.4% African American, and 3.2% unknown. BAT MRIs included diffusion weighted imaging, T2 gradient echo, T2 axial, and FLAIR sequences. The algorithm for BAT MRI use is shown in Figure 1. BAT MRIs were evaluated for ischemia, hemorrhage and other central nervous system (CNS) pathologies. Stroke risk factor correlates of abnormal BAT MRIs were assessed using t-test for continuous variables and Fisher's Exact Test for categorical variables. Results: Of the 31 BAT MRIs, 13 were read as abnormal (11-acute ischemia, 1-hemorrhage, 1-ischemia with hemorrhage). The hemorrhage was in the pons on BAT MRI and was not detected by CT. This finding excluded using IV TPA in this patient. Two cases where BAT MRI demonstrated AIS met NINDS/ECASS-III criteria and received IV TPA. Of the 18, in whom BAT MRI was read as normal, 9 had a discharge diagnosis of TIA, 2 MRI negative strokes, 3 conversion disorders, 1 CNS neoplasm, 1 respiratory failure and 1 peripheral vertigo. Stroke risk factor analysis yielded no significant correlation between BAT MRI findings and gender, race, prior stroke/TIA, coronary artery disease, diabetes, hyperlipidemia, hypertension, or smoking. Patients with AIS on BAT MRI were older (68.2 ± 17.5) than those without (58.6 ± 9.7); although, it bordered statistical significance (p=0.08). Atrial fibrillation correlated with AIS on BAT MRI (p=0.02). Conclusion: In patients with AIS-like symptoms, BAT MRI may be used to confirm AIS, exclude stroke mimics and assess candidacy for IV TPA. Atrial fibrillation correlated with AIS on BAT MRI; therefore, these patients may be more likely to be IV TPA candidates.


2014 ◽  
Vol 111 (03) ◽  
pp. 385-391 ◽  
Author(s):  
Christine Albert ◽  
Felicita Andreotti ◽  
Lina Badimon ◽  
Isabelle Van Gelder ◽  
Elaine Hylek ◽  
...  

SummaryAtrial fibrillation (AF) is an independent risk factor for thromboembolism and stroke. Women with AF are at a higher overall risk for thromboembolic stroke when compared to men with AF. Recent evidence suggests that female sex, after adjusting for stroke risk profile and sex differences in utilisation of anticoagulation, is an independent stroke risk factor in AF. The inclusion of female sex has improved the accuracy of the CHADS2 stroke risk stratification schema (Congestive heart failure, Hypertension, Age 75 years or greater, Diabetes mellitus, and prior Stroke or TIA). The newly revised and validated schema, CHA2DS2-VASc, dichotomises age and incorporates female sex and vascular disease history. The pathophysiological mechanisms to explain this increased risk in women are not well understood. According to Virchow’s triad, thrombosis that leads to stroke in AF should arise from three co-existing phenomena: structural abnormalities, blood stasis, and a hypercoagulable state. Herein, we explore the sex differences in the biological processes that lead to thrombus formation as applied to Virchow’s Triad. The objective of this review is to describe the potential mechanisms behind the increased risk of stroke in AF associated with female sex.


2020 ◽  
Vol 29 (1) ◽  
pp. 86-93 ◽  
Author(s):  
Varun Malik ◽  
Anand N. Ganesan ◽  
Joseph B. Selvanayagam ◽  
Derek P. Chew ◽  
Andrew D. McGavigan

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