scholarly journals New artificial intelligence prediction model using serial prothrombin time international normalized ratio measurements in atrial fibrillation patients on vitamin K antagonists: GARFIELD-AF

2019 ◽  
Vol 6 (5) ◽  
pp. 301-309 ◽  
Author(s):  
Shinichi Goto ◽  
Shinya Goto ◽  
Karen S Pieper ◽  
Jean-Pierre Bassand ◽  
Alan John Camm ◽  
...  
Keyword(s):  
Neural Network ◽  
Artificial Intelligence ◽  
Atrial Fibrillation ◽  
Prothrombin Time ◽  
Clinical Outcomes ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
International Normalized Ratio ◽  
One Dimensional ◽  
Major Bleed

Abstract Aims Most clinical risk stratification models are based on measurement at a single time-point rather than serial measurements. Artificial intelligence (AI) is able to predict one-dimensional outcomes from multi-dimensional datasets. Using data from Global Anticoagulant Registry in the Field (GARFIELD)-AF registry, a new AI model was developed for predicting clinical outcomes in atrial fibrillation (AF) patients up to 1 year based on sequential measures of prothrombin time international normalized ratio (PT-INR) within 30 days of enrolment. Methods and results Patients with newly diagnosed AF who were treated with vitamin K antagonists (VKAs) and had at least three measurements of PT-INR taken over the first 30 days after prescription were analysed. The AI model was constructed with multilayer neural network including long short-term memory and one-dimensional convolution layers. The neural network was trained using PT-INR measurements within days 0–30 after starting treatment and clinical outcomes over days 31–365 in a derivation cohort (cohorts 1–3; n = 3185). Accuracy of the AI model at predicting major bleed, stroke/systemic embolism (SE), and death was assessed in a validation cohort (cohorts 4–5; n = 1523). The model’s c-statistic for predicting major bleed, stroke/SE, and all-cause death was 0.75, 0.70, and 0.61, respectively. Conclusions Using serial PT-INR values collected within 1 month after starting VKA, the new AI model performed better than time in therapeutic range at predicting clinical outcomes occurring up to 12 months thereafter. Serial PT-INR values contain important information that can be analysed by computer to help predict adverse clinical outcomes.

scholarly journals The international normalized ratio (INR) as seen in a population of patients with atrial fibrillation and cerebral infarction undergoing long-term treatment with vitamin K antagonists

2015 ◽  
Vol 28 (4) ◽  
pp. 269-272
Author(s):  
Anna Szczepańska-Szerej ◽  
Magdalena Wojtan ◽  
Beata Szajnoga
Keyword(s):  
Atrial Fibrillation ◽  
Cerebral Infarction ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
International Normalized Ratio ◽  
Blood Parameters ◽  
Term Treatment ◽  
Adequate Treatment ◽  
Long Term Treatment

Abstract It is estimated that nearly 20% of all cerebral infarctions in the total population are the result of a complication of atrial fibrillation (AF). While oral anticoagulation with vitamin K antagonists (AVKs) substantially reduces this risk, this requires regular monitoring of the international normalized ratio (INR) in order to achieve therapeutic levels (2,0-3,0). The aim of this study was to evaluate a group at high risk of cerebral infarction, among patients with AF undergoing long-term treatment with VKAs, taking into account the significance of therapeutic INR values. The analysed group consisted of 90 acute ischaemic stroke patients with paroxysmal or chronic “non-valvular” AF, receiving treatment with VKAs. As a result of the study, therapeutic INR values (≥ 2) were seen in thirty-five of these individuals (38,8%), while 55 (61,2%) showed non-therapeutic INR values. Moreover, there were no differences in demographics, vascular risk factors, biochemical and morphological blood parameters, mean CHA2DS2-VASc score and TOAST classification between either of the two groups. Furthermore, no additional factor that would increase their risk of cerebral infarction during the adequate treatment with VKAs was found. However, patients with non-therapeutic INR values had a statistically significantly higher frequency of concomitant moderate pathology of the bicuspid valve, p<0.05. Hence, a lack of proper control of INR can proved to be particularly dangerous for this subgroup of patients. Hence, this is a group with an elevated risk of cerebral infarction and therefore requires special oversight of VKA treatment or NOA treatment.

scholarly journals Effectivity of a joint didactic intervention by School for Patients on inappropriate control prothrombin time anticoagulated patients. Protocol for developing a randomized and controlled clinical trial.

2020 ◽  
Author(s):  
Leovigildo Ginel-Mendoza ◽  
Alfonso Hidalgo Hidalgo-Natera ◽  
Rocio Reina-Gonzalez ◽  
Rafael Poyato-Ramos ◽  
Inmaculada Lupianez-Perez ◽  
...  
Keyword(s):  
Social Support ◽  
Clinical Trial ◽  
Prothrombin Time ◽  
Vitamin K ◽  
Oral Anticoagulant ◽  
Vitamin K Antagonists ◽  
International Normalized Ratio ◽  
Control Group ◽  
Therapeutic Level ◽  
Anticoagulated Patients

Abstract Background Oral anticoagulant drugs represent an essential tool in thrombo-embolic events prevention. Most used are vitamin K antagonists, whose plasma level is monitored by measuring prothrombin time using the International Normalized Ratio. If it takes values out of the recommended range, the patient will have a higher risk of suffering from thromboembolic or hemorrhagic complications. Previous research has shown that about 33% of total patients keep values on inappropriate level. The purpose of the study is to improve International Normalized Ratio control figures by a joint didactic intervention based on the Junta de Andalucía School for Patients method that will be implemented by anticoagulated patients themselves. Methods A randomized clinical trial was carried out at primary care centers from one healthcare area in Málaga (Andalusia, Spain). Study population: patients included in an oral anticoagulant therapy program consisting in using vitamin K antagonists. First step detection of patients on oral anticoagulation program with International Normalized Ratio control on therapeutic level during 65% or less over total time. Second step: patients with inappropriate International Normalized Ratio control were included in two groups: Group 1 or Joint Intervention Group: patients were instructed a joint didactic intervention “from peer to peer”, by a previously trained and expert anticoagulated patient. Group 2 or Control Group: Control group performed usual clinical practice: people were schedule by nurses about one time per month, except cases in which controls were inappropriate; in those circumstances patients were schedule before that period expired. In order to built the study group and the control group, 312 individuals were required (156 in each group) to detect differences in INR figures equal or higher than 15% between both groups. Study variables time on therapeutic levels before and after intervention, sociodemographic variables, vital signs, existence of cardiovascular risk factors or accompanying diseases in the clinical records, laboratory test including complete blood count, bleeding time, and prothrombin time or partial thromboplastin time and blood chemistry, other prescribed drugs, and social support. Almost-experimental analytic study with before-after statistical analysis of the intervention were made. Lineal regression models were applied on main variables results (International Normalized Ratio value, time on therapeutic level) inputting sociodemographic variables, accompanying diseases and social support.

scholarly journals Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial

EP Europace ◽  
2020 ◽  
Author(s):  
Stefan H Hohnloser ◽  
A John Camm ◽  
Riccardo Cappato ◽  
Hans-Christoph Diener ◽  
Hein Heidbüchel ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Study Drug ◽  
International Normalized Ratio ◽  
P Value ◽  
Group 14 ◽  
Group 13 ◽  
Post Hoc ◽  
Higher Doses

Abstract Aims  This post hoc analysis of ELIMINATE-AF evaluated requirements of unfractionated heparin (UFH) and procedure-related bleeding in atrial fibrillation (AF) patients undergoing ablation with uninterrupted edoxaban or vitamin K antagonist (VKA) therapy. Methods and results  Patients were randomized 2:1 to once-daily edoxaban 60 mg (or dose-reduced 30 mg) or dose-adjusted VKA (target international normalized ratio: 2.0–3.0). Uninterrupted anticoagulation was mandated for 21–28 days’ pre-ablation and 90 days’ post-ablation. During ablation, UFH administration targeted an activated clotting time (ACT) of 300–400 s. Periprocedural bleeding was differentiated between procedure-related (bleeding at puncture side, cardiac tamponade) and unrelated events. Of 614 randomized patients, 553 received study drug and underwent catheter ablation (edoxaban n = 375; VKA n = 178). The median (Q1–Q3) time from last dose to ablation procedure was 14.8 (13.3–16.5) vs. 16.5 (14.8–19.5) h (edoxaban vs. VKA group, respectively). Mean ACT (SD) ≥300 s was observed in 52% edoxaban- vs. 76% VKA-treated patients, despite a higher mean (SD) UFH dose in the edoxaban vs. VKA group [14 261 (6397) IU vs. 11 473 (4300) IU; exploratory P-value &lt; 0.0001]. In the edoxaban group, 13 patients (3.5%) had procedure-related bleeds of whom 9 had received an UFH dose above the median (13 000 IU). In the VKA arm, 7 patients (3.9%) had procedure-related bleeds of whom 3 had received an UFH dose above the median (10 225 IU). Conclusion  The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.

scholarly journals Should we Test the Prothrombin Time in Anticoagulated Epistaxis Patients?

2013 ◽  
Vol 4 (1) ◽  
pp. ar.2013.4.0049 ◽  
Author(s):  
Michael B. Soyka ◽  
David Holzmann
Keyword(s):  
Prothrombin Time ◽  
Vitamin K ◽  
Oral Anticoagulation ◽  
Vitamin K Antagonists ◽  
International Normalized Ratio ◽  
Increased Risk

Epistaxis is one of the most frequent emergencies in rhinology. Patients using anticoagulative medication are at increased risk for epistaxis. We evaluated the prothrombin time and the international normalized ratio (INR) in anticoagulated epistaxis patients. Patients suffering from epistaxis were prospectively included in a database and results from prothrombin testing were analyzed in the context of anticoagulation. One hundred sixteen of 591 epistaxis cases were identified to be on oral anticoagulation. The INR was found to be above therapeutic levels in 19 (16%) of these cases. We strongly recommend prothrombin time and INR testing in all epistaxis patients taking any sort of vitamin K antagonists.

Use of oral anticoagulants in combination with antiplatelet(s) in atrial fibrillation

Heart ◽  
2017 ◽  
Vol 104 (11) ◽  
pp. 912-920 ◽  
Author(s):  
Caroline Sindet-Pedersen ◽  
Laila Staerk ◽  
Morten Lamberts ◽  
Thomas Alexander Gerds ◽  
Jeffrey S Berger ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Temporal Trends ◽  
Coronary Intervention ◽  
International Normalized Ratio ◽  
Exposure Variable ◽  
History Of ◽  
Study Population

ObjectivesTo investigate temporal trends in the use of non-vitamin K oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) in combination with aspirin and/or clopidogrel in patients with atrial fibrillation (AF) following acute myocardial infarction (MI) and/or percutaneous coronary intervention (PCI).MethodsUsing Danish nationwide registries, all patients with AF who survived 30 days after discharge from MI and/or PCI between 22 August 2011 and 30 September 2016 were identified.ResultsA total of 2946 patients were included in the study population, of whom 1967 (66.8%) patients were treated with VKA in combination with antiplatelet(s) (VKA+aspirin n=477, VKA+clopidogrel n=439, VKA+aspirin+clopidogrel n=1051) and 979 (33.2%) patients were treated with NOAC in combination with antiplatelet(s) (NOAC+aspirin n=252, NOAC+clopidogrel n=218, NOAC+aspirin+clopidogrel n=509). The overall study population had a median age of 76 years [IQR: 69–82] and consisted of 1995 (67.7%) men. Patients with MI as inclusion event accounted for 1613 patients (54.8%). Patients with high CHA2DS2-VASc score(congestive heart failure, hypertension, age ≥75 years (2 points), diabetes mellitus, history of stroke/transient ischemic attack/systemic thromboembolism (2 points), vascular disease, age 65-75 years, and female sex) accounted for 132 2814 (95.5%) of patients, and patients with high HAS-BLED score (hypertension, abnormal renal/liver function, history of stroke, history of bleeding, age >65 years, non-steroidal anti-inflammatory drug usages, or alcohol abuse, leaving out labile international normalized ratio (not available), and use of antiplatelets (exposure variable)) accounted for 934 (31.7%) of patients. There was an increase from 10% in 2011 to 52% in 2016 in the use of NOACs in combination with antiplatelet(s).ConclusionFrom 2011 to 2016, the use of NOAC in combination with antiplatelet(s) increased in patients with AF following MI/PCI and exceeded the use of VKA in combination with antiplatelet(s) by 2016.

High Soluble Thrombomodulin Is Associated with an Increased Risk of Major Bleeding during Treatment with Oral Anticoagulants: A Case–Cohort Study

2020 ◽  
Author(s):  
Myrthe M. A. Toorop ◽  
Nienke van Rein ◽  
Suzanne C. Cannegieter ◽  
Felix J. M. van der Meer ◽  
Pieter H. Reitsma ◽  
...  
Keyword(s):  
Cohort Study ◽  
Vitamin K ◽  
Major Bleeding ◽  
Cox Regression ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
International Normalized Ratio ◽  
Soluble Thrombomodulin ◽  
Major Bleed ◽  
Increased Risk

Abstract Background Major bleeding occurs in 1 to 3% of patients treated with oral anticoagulants per year. Biomarkers may help to identify high-risk patients. A proposed marker for major bleeding while using anticoagulants is soluble thrombomodulin (sTM). Methods Plasma was available from 16,570 patients of the BLEEDS cohort that consisted of patients who started treatment with vitamin K antagonists between 2012 and 2014. A case–cohort study was performed including all patients with a major bleed (n = 326) during follow-up and a random sample of individuals selected at baseline (n = 652). Plasma sTM levels were measured and stratified by percentiles. Patients were also categorized by international normalized ratio (INR). Adjusted hazard ratios (for age, sex, hypertension, and diabetes) with 95% confidence intervals (CIs) were estimated by means of Cox regression. Results Plasma sTM levels were available for 263 patients with a major bleed and 538 control subjects. sTM levels were dose-dependently associated with risk of major bleeding, with a 1.9-fold increased risk (95% CI: 1.1–3.1) for levels above the 85th percentile versus the <25th percentile. A high INR (≥4) in the presence of high (≥70th percentile) sTM levels was associated with a 7.1-fold (95% CI: 4.1–12.3) increased risk of major bleeding, corresponding with a bleeding rate of 14.1 per 100 patient-years. Conclusion High sTM levels at the start of treatment are associated with major bleeding during vitamin K antagonist treatment, particularly in the presence of a high INR.

A new index to predict quality of anticoagulation control in patients on vitamin K antagonists: the DAFNE score

2020 ◽  
Author(s):  
Vivencio Barrios ◽  
Carlos Escobar ◽  
Luis Prieto ◽  
Jose Polo ◽  
Javier Muñiz ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Cardiovascular Disease ◽  
High Risk ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Clinical Score ◽  
International Normalized Ratio ◽  
Concomitant Treatment ◽  
Anticoagulation Control

Aim: To derive a new clinical score to improve the prediction of those at risk of poor International Normalized Ratio control among patients with atrial fibrillation taking vitamin K antagonists. Materials & methods: The score was calculated using PAULA database and validated in the FANTASIIA population. Results: The DAFNE score (cardiovascular Disease, concomitant treatment with Amiodarone, Food/dietary transgression and taking ≥7 pills daily, fEemale sex) score was related to a higher probability of poor International Normalized Ratio control. C-indexes were 0.611 and 0.576 (De Long test, p = 0.007) for the DAFNE and SAMe-TT2R2 scores, respectively. Conclusion: The DAFNE score is a new clinical score which may potentially help determine those patients with atrial fibrillation who are at high risk of poor anticoagulation control with vitamin K antagonists.

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