Evaluation of Abbreviated Versus Conventional Course of Dabigatran Etexilate Before Electric Cardioversion in Patients With Atrial Fibrillation (RE-SOUND Study)

Author(s):  
Drugs ◽  
2017 ◽  
Vol 77 (3) ◽  
pp. 331-344 ◽  
Author(s):  
Hannah A. Blair ◽  
Gillian M. Keating

Author(s):  
Eileen Fonseca ◽  
David R Walker ◽  
Gregory P Hess

Background: Warfarin and dabigatran etexilate (DE) are oral anticoagulants (OAC) used to reduce the risk of stroke among patients with nonvalvular atrial fibrillation (AF). However, DE does not require titration and INR monitoring. This study examined whether hospital length of stay (LOS) and total hospital costs differed between the two therapies among treatment-naive, newly-diagnosed AF patients. Methods: LOS and total hospital costs were evaluated for hospitalizations with a primary or secondary discharge diagnosis of atrial fibrillation (AF) between 1/1/2011-3/31/2012, with DE or warfarin administered during hospitalization, and excluding hospitalizations of patients with valvular AF, previously diagnosed with AF, or previously treated with OAC. Hospitalizations were identified from a Charge Detail Masters database containing 397 qualified hospitals. Samples were propensity score matched using nearest neighbor within a caliper of 0.20 standard deviations of the logit, without replacement and a 2:1 match. Differences in LOS and hospital cost were then estimated using generalized linear models, fitted by generalized estimating equations (clustered by hospital) to account for possible correlation between observations. The hospitalization’s charged amount was multiplied by the hospital’s inpatient cost-to-charge ratio to estimate the total hospital cost. Covariates estimating the propensity score, LOS, and costs included patient age, payer type, CHADS 2 and HAS-BLED scores, use of bridging agents, comorbid conditions, and hospital attributes. As a sensitivity analysis, LOS and costs were estimated with the same parameters and covariates among the raw, unbalanced sample. Results: Matched samples included 1,292 warfarin and 646 DE hospitalizations of treatment-naive, newly diagnosed patients out of 4,619 and 715 hospitalizations, respectively. No covariates used in matching had standardized mean differences > 10% after matching. Two comorbidities (thromboembolism, coronary artery disease) had statistically different distributions after matching (DE: 3% vs. warfarin: 8%, p<0.001 and DE: 40% vs. warfarin: 45%, p=0.048); these were included as model covariates. Among the sample, DE had an estimated 0.7 days shorter stay compared to warfarin (DE: 4.8 days vs. warfarin: 5.5 days, p<0.01) and a $2,031 lower estimated total cost (DE: $14,794 vs warfarin: $16,826, p=0.007). Sensitivity analysis confirmed a shorter DE LOS (DE: 5.5 days vs. warfarin: 6.6 days, delta=1.1 days, p<0.01) and a lower DE hospital cost (DE: $18,362 vs. warfarin: $22,602, delta=$4,240, p<0.01). Conclusions: Among hospitalizations of treatment-naive patients newly diagnosed with nonvalvular AF, the hospitalizations during which DE was administered had a shorter LOS and at least a 12% lower total hospital cost compared to hospitalizations where warfarin was administered.


Author(s):  
David R Walker ◽  
Jasmina Ivanova ◽  
Keith A Betts ◽  
Sapna Rao ◽  
Eric Q Wu

Background and Objective: Dabigatran etexilate (DE) and warfarin, both oral anticoagulants used for stroke risk reduction in patients with non-valvular atrial fibrillation (NVAF), have been or are being compared in several comparative effectiveness studies. Understanding patient characteristics of those prescribed DE vs. warfarin are important for interpreting such studies. The objective of this study is to identify the characteristics that differentiate NVAF patients prescribed DE versus warfarin as first-line anticoagulation. Methods: An online survey was administered in October 2012 to an established panel of cardiologists and primary care physicians (PCPs) in the US. Physicians were asked to identify medical charts of their patients diagnosed with NVAF and who had at least one prescription for DE or warfarin between 1/1/2011 and 6/30/2012. Patients were further required to be anticoagulant naïve prior to the first prescription of DE or warfarin. A computer generated random dice was applied to direct the random selection of the patients. Patient characteristics, comorbidities and clinical risk measures were compared between DE and warfarin patients using Chi-square tests for categorical variables and t-tests for continuous variables. A logistic regression model was utilized to evaluate patient characteristics associated with DE vs. warfarin use among anticoagulant naïve NVAF patients. Results: A total of 288 physicians (144 cardiologists and 144 PCPs) completed the survey. 262 medical records for DE patients and 247 for warfarin patients were randomly selected. The mean age of the DE and warfarin patients, respectively were 61.6 and 65.8 years (p < 0.01). The proportion of females was 20.6% and 41.7% in the DE and warfarin patients respectively (p<0.01). 86.3% of DE patients vs. 68.4% of warfarin patients were Caucasian (p<0.01). Other differences between DE and warfarin patients respectively included: previous myocardial infarction (3.8%, 9.3%; p<0.05), previous transient ischemic attack (8.4%, 16.2%; p <0.01), and CHA 2 DS 2 -VASc stroke risk score (2.21, 2.98; p<0.01). The logistic regression model found age (OR = 0.96; p=0.001), female gender (OR=0.46; p = 0.002), Hispanic/Latino (OR = 0.33; p=.007), Black (OR= 0.37; p = 0.006), and > 6 months and < 1 year for time from first NVAF diagnosis to first prescription date (OR = 0.38; p = 0.02) were associated with initiation of DE vs. warfarin. However, CHA 2 DS 2 -VASc was not found to be a significant predictor of anticoagulant prescription. Conclusions: Patients who are younger, male, Caucasian, and recently diagnosed with NVAF were significantly more likely to be initiated by their physician on DE vs. warfarin. These findings should be considered when doing comparative analyses of outcomes between patients on DE vs. warfarin.


Author(s):  
Eileen Fonseca ◽  
David R Walker ◽  
Gregory P Hess

Background: Warfarin and dabigatran etexilate (DE) are oral anticoagulants (OAC) that reduce stroke risk among patients with nonvalvular atrial fibrillation (AF). However, DE does not require titration and INR monitoring. This study examined whether emergency department (ED) rate of admissions differed between the two therapies. Methods: Admission rate was evaluated for hospital encounters initiated in the ED, with a primary or secondary discharge diagnosis of AF between 1/1/2011-3/31/2012, with DE or warfarin administered during the encounter, and excluding encounters of valvular AF patients. Encounters were identified from a hospital Charge Detail Masters database containing 387 eligible hospitals. Samples were propensity score matched using nearest neighbor within a caliper of 0.20 standard deviations of the logit, without replacement, and a 2:1 match. Admission rates were estimated for encounters representing previously-treated patients and those representing treatment-naive patients using binominal generalized linear models, fitted by generalized estimating equations (clustered by hospital). Covariates estimating the propensity score and admission rate included age, payer type, use of bridging agents, AF as primary or secondary diagnosis, CHADS 2 and HAS-BLED scores, comorbid conditions, and hospital attributes. As a sensitivity analysis, admission rate was also estimated from the unmatched sample. Results: Matched samples included 2,688 warfarin and 1,344 DE ED encounters of previously-treated patients out of 15,053 and 1,367 ED encounters, respectively; and 2,578 warfarin and 1,289 DE ED encounters of OAC-treatment-naive patients out of 8,361 and 1,406 ED encounters, respectively. There were too few (n<5) matched encounters where the patient had prior OAC use but were new to the drug administered during the encounter, so these were excluded. No covariates used in matching had standardized mean differences > 10% after matching. Among the previously-treated sample, the estimated admission rate was 3.2% lower for DE compared to warfarin (88.3% vs. 91.5%, p=0.010) with sensitivity analysis confirming a lower admission rate for DE (91.1% vs. 93.8%, delta=2.7%, p=0.001). Among the treatment-naive sample, DE had a 1.2% lower admission rate compared to warfarin (95.2% vs. 96.3%, p=0.048). Sensitivity analysis confirmed a lower admission rate for DE (95.5% vs. 97.0%, delta=1.5%, p=0.001). Conclusions: While the vast majority of AF encounters initiated in the ED result in admission, encounters where patients were treated with DE as continuing or new therapy were less likely to be admitted compared to similar encounters where warfarin was administered.


2011 ◽  
Vol 2011 ◽  
pp. 1-23 ◽  
Author(s):  
M. Àngels Font ◽  
Jerzy Krupinski ◽  
Adrià Arboix

Embolism of cardiac origin accounts for about 20% of ischemic strokes. Nonvalvular atrial fibrillation is the most frequent cause of cardioembolic stroke. Approximately 1% of population is affected by atrial fibrillation, and its prevalence is growing with ageing in the modern world. Strokes due to cardioembolism are in general severe and prone to early recurrence and have a higher long-term risk of recurrence and mortality. Despite its enormous preventive potential, continuous oral anticoagulation is prescribed for less than half of patients with atrial fibrillation who have risk factors for cardioembolism and no contraindications for anticoagulation. Available evidence does not support routine immediate anticoagulation of acute cardioembolic stroke. Anticoagulation therapy's associated risk of hemorrhage and monitoring requirements have encouraged the investigation of alternative therapies for individuals with atrial fibrillation. New anticoagulants being tested for prevention of stroke are low-molecular-weight heparins (LMWH), unfractionated heparin, factor Xa inhibitors, or direct thrombin inhibitors like dabigatran etexilate and rivaroxaban. The later exhibit stable pharmacokinetics obviating the need for coagulation monitoring or dose titration, and they lack clinically significant food or drug interaction. Moreover, they offer another potential that includes fixed dosing, oral administration, and rapid onset of action. There are several concerns regarding potential harm, including an increased risk for hepatotoxicity, clinically significant bleeding, and acute coronary events. Therefore, additional trials and postmarketing surveillance will be needed.


TH Open ◽  
2018 ◽  
Vol 02 (03) ◽  
pp. e280-e290 ◽  
Author(s):  
Willemijn Comuth ◽  
Henrik Lauridsen ◽  
Steen Kristensen ◽  
Anna-Marie Münster

Background The Anti-Clot Treatment Scale (ACTS) is a 17-item, 2-factor (Burdens and Benefits), patient-reported outcome instrument to evaluate patient satisfaction with oral anticoagulant treatment. Objectives This study aimed to translate and culturally adapt the English version of the ACTS into Danish and to subsequently validate the Danish version in a population of patients treated with dabigatran etexilate for atrial fibrillation. Methods The ACTS was translated into Danish and culturally adapted. This prospective phase 4 study included 232 respondents who completed the Danish ACTS after 1 month of treatment with dabigatran etexilate for atrial fibrillation. Psychometric properties were evaluated. For test–retest reliability, the ACTS was measured twice, 2 weeks apart, in a subgroup of 50 stable patients. Results Generally, a high level of treatment satisfaction was found. Confirmatory factor analysis showed a suboptimal fit for the two-factor model of the original version. Using modification indices of confirmatory factor analysis, a four-factor model had the best fit. Cronbach's α for internal consistency was acceptable at 0.78. There was good test–retest reliability with intraclass correlation at 0.80. Smallest detectable changes (SDCs) for individual patients were 5.89 points for the total ACTS, 5.57 for the reverse Burdens, and 3.34 for Benefits scores. Group SDCs were 0.39, 0.37, and 0.22 respectively. Substantial ceiling effects limit the ability to detect improvement at the high end of the scale. Conclusion The Danish version of the ACTS has inadequate structural validity. Reliability was acceptable. Ceiling effects challenge detection of improvement of treatment satisfaction in clinical practice in this patient population.


2001 ◽  
Vol 11 (2) ◽  
pp. 95-99 ◽  
Author(s):  
Darius G. Nabavi ◽  
Achim Allroggen ◽  
Holger Reinecke ◽  
Vendel Kemény ◽  
Dirk W. Droste ◽  
...  

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