Document Detail


Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48.
MedLine Citation:
PMID:  24947287     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND AND PURPOSE: The once-daily oral factor Xa inhibitor, edoxaban, is as effective as warfarin in preventing stroke and systemic embolism while decreasing bleeding in a phase III trial of patients with atrial fibrillation at moderate-high stroke risk. Limited data regarding cerebrovascular events with edoxaban were reported previously.
METHODS: We analyzed the subtypes of cerebrovascular events in 21 105 patients participating in Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) comparing outcomes among patients randomized to warfarin versus 2 edoxaban regimens (high dose, low dose). The primary end point for this prespecified analysis of cerebrovascular events was all stroke (ischemic plus hemorrhagic), defined as an abrupt onset of focal neurological deficit because of infarction or bleeding with symptoms lasting ≥24 hours or fatal in <24 hours. Independent stroke neurologists unaware of treatment adjudicated all cerebrovascular events.
RESULTS: Patients randomized to high-dose edoxaban had fewer strokes on-treatment (hazard ratio, 0.80; 95% confidence interval, 0.65-0.98) than warfarin (median time-in-therapeutic range, 68.4%); patients in the low-dose edoxaban group had similar rates (hazard ratio, 1.10 versus warfarin; 95% confidence interval, 0.91-1.32). Rates of ischemic stroke or transient ischemic attack were similar with high-dose edoxaban (1.76% per year) and warfarin (1.73% per year; P=0.81), but more frequent with low-dose edoxaban (2.48% per year; P<0.001). Both edoxaban regimens significantly reduced hemorrhagic stroke and other subtypes of intracranial bleeds.
CONCLUSIONS: In patients with atrial fibrillation, once-daily edoxaban was as effective as warfarin in preventing all strokes, with significant reductions in various subtypes of intracranial bleeding. Ischemic cerebrovascular event rates were similar with high-dose edoxaban and warfarin, whereas low-dose edoxaban was less effective than warfarin.
CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00781391.
Authors:
Robert P Giugliano; Christian T Ruff; Natalia S Rost; Scott Silverman; Stephen D Wiviott; Cheryl Lowe; Naveen Deenadayalu; Sabina A Murphy; Laura T Grip; Joshua M Betcher; Anil Duggal; Jay Dave; Minggao Shi; Michele Mercuri; Elliott M Antman; Eugene Braunwald;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2014-06-19
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  45     ISSN:  1524-4628     ISO Abbreviation:  Stroke     Publication Date:  2014 Aug 
Date Detail:
Created Date:  2014-07-29     Completed Date:  2014-10-09     Revised Date:  2014-11-13    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2372-8     Citation Subset:  IM    
Copyright Information:
© 2014 American Heart Association, Inc.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00781391
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MeSH Terms
Descriptor/Qualifier:
Aged
Anticoagulants / administration & dosage,  adverse effects,  therapeutic use*
Atrial Fibrillation / drug therapy*
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Male
Middle Aged
Pyridines / administration & dosage,  adverse effects,  therapeutic use*
Stroke / chemically induced*
Thiazoles / administration & dosage,  adverse effects,  therapeutic use*
Treatment Outcome
Warfarin / administration & dosage,  adverse effects,  therapeutic use*
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Pyridines; 0/Thiazoles; 480449-70-5/edoxaban; 5Q7ZVV76EI/Warfarin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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