Document Detail

The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy).
MedLine Citation:
PMID:  24076487     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The goal of this study was to analyze the impact of dabigatran plasma concentrations, patient demographics, and aspirin (ASA) use on frequencies of ischemic strokes/systemic emboli and major bleeds in atrial fibrillation patients.
BACKGROUND: The efficacy and safety of dabigatran etexilate were demonstrated in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial, but a therapeutic concentration range has not been defined.
METHODS: In a pre-specified analysis of RE-LY, plasma concentrations of dabigatran were determined in patients treated with dabigatran etexilate 110 mg twice daily (bid) or 150 mg bid and correlated with the clinical outcomes of ischemic stroke/systemic embolism and major bleeding using univariate and multivariate logistic regression and Cox regression models. Patient demographics and ASA use were assessed descriptively and as covariates.
RESULTS: Plasma concentrations were obtained from 9,183 patients, with 112 ischemic strokes/systemic emboli (1.3%) and 323 major bleeds (3.8%) recorded. Dabigatran levels were dependent on renal function, age, weight, and female sex, but not ethnicity, geographic region, ASA use, or clopidogrel use. A multiple logistic regression model (c-statistic 0.657, 95% confidence interval [CI]: 0.61 to 0.71) showed that the risk of ischemic events was inversely related to trough dabigatran concentrations (p = 0.045), with age and previous stroke (both p < 0.0001) as significant covariates. Multiple logistic regression (c-statistic 0.715, 95% CI: 0.69 to 0.74) showed major bleeding risk increased with dabigatran exposure (p < 0.0001), age (p < 0.0001), ASA use (p < 0.0003), and diabetes (p = 0.018) as significant covariates.
CONCLUSIONS: Ischemic stroke and bleeding outcomes were correlated with dabigatran plasma concentrations. Age was the most important covariate. Individual benefit-risk might be improved by tailoring dabigatran dose after considering selected patient characteristics. (Randomized Evaluation of Long Term Anticoagulant Therapy [RE-LY] With Dabigatran Etexilate; NCT00262600).
Paul A Reilly; Thorsten Lehr; Sebastian Haertter; Stuart J Connolly; Salim Yusuf; John W Eikelboom; Michael D Ezekowitz; Gerhard Nehmiz; Susan Wang; Lars Wallentin;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial     Date:  2013-09-27
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  63     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2014 Feb 
Date Detail:
Created Date:  2014-01-31     Completed Date:  2014-03-26     Revised Date:  2014-10-05    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  321-8     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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MeSH Terms
Age Factors
Antithrombins / administration & dosage,  adverse effects,  blood*
Aspirin / therapeutic use
Atrial Fibrillation / blood,  drug therapy
Benzimidazoles / administration & dosage,  adverse effects,  blood*
Diabetes Mellitus / epidemiology
Embolism / prevention & control
Hemorrhage / epidemiology*
Multivariate Analysis
Platelet Aggregation Inhibitors / therapeutic use
Pyridines / administration & dosage,  adverse effects,  blood*
Risk Assessment
Stroke / epidemiology*,  prevention & control
Reg. No./Substance:
0/Antithrombins; 0/Benzimidazoles; 0/Platelet Aggregation Inhibitors; 0/Pyridines; 2E18WX195X/dabigatran etexilate; R16CO5Y76E/Aspirin
Comment In:
J Am Coll Cardiol. 2014 Jun 24;63(24):2746-7   [PMID:  24681150 ]
J Am Coll Cardiol. 2014 Aug 26;64(8):847-8   [PMID:  25145533 ]
J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2885   [PMID:  24814491 ]
J Am Coll Cardiol. 2014 Jul 1;63(25 Pt A):2885-6   [PMID:  24814492 ]

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