Document Detail


Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts.
MedLine Citation:
PMID:  23212720     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: We sought to define the factors associated with the occurrence of stroke and systemic embolism in a large, international atrial fibrillation (AF) trial.
METHODS AND RESULTS: In ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation), 14 264 patients with nonvalvular AF and creatinine clearance ≥30 mL/min were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards modeling was used to identify factors at randomization independently associated with the occurrence of stroke or non-central nervous system embolism based on intention-to-treat analysis. A risk score was developed in ROCKET AF and validated in ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation), an independent AF patient cohort. Over a median follow-up of 1.94 years, 575 patients (4.0%) experienced primary end-point events. Reduced creatinine clearance was a strong, independent predictor of stroke and systemic embolism, second only to prior stroke or transient ischemic attack. Additional factors associated with stroke and systemic embolism included elevated diastolic blood pressure and heart rate, as well as vascular disease of the heart and limbs (C-index 0.635). A model that included creatinine clearance (R(2)CHADS(2)) improved net reclassification index by 6.2% compared with CHA(2)DS(2)VASc (C statistic=0.578) and by 8.2% compared with CHADS(2) (C statistic=0.575). The inclusion of creatinine clearance <60 mL/min and prior stroke or transient ischemic attack in a model with no other covariates led to a C statistic of 0.590.Validation of R(2)CHADS(2) in an external, separate population improved net reclassification index by 17.4% (95% confidence interval, 12.1%-22.5%) relative to CHADS(2).
CONCLUSIONS: In patients with nonvalvular AF at moderate to high risk of stroke, impaired renal function is a potent predictor of stroke and systemic embolism. Stroke risk stratification in patients with AF should include renal function.
CLINICAL TRIAL REGISTRATION: URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00403767.
Authors:
Jonathan P Piccini; Susanna R Stevens; YuChiao Chang; Daniel E Singer; Yuliya Lokhnygina; Alan S Go; Manesh R Patel; Kenneth W Mahaffey; Jonathan L Halperin; Günter Breithardt; Graeme J Hankey; Werner Hacke; Richard C Becker; Christopher C Nessel; Keith A A Fox; Robert M Califf;
Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-12-03
Journal Detail:
Title:  Circulation     Volume:  127     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-01-15     Completed Date:  2013-03-12     Revised Date:  2013-10-22    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  224-32     Citation Subset:  AIM; IM    
Affiliation:
Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27710, USA. jonathan.piccini@duke.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00403767
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Aged
Anticoagulants / administration & dosage
Atrial Fibrillation / drug therapy*,  epidemiology
Double-Blind Method
Embolism / epidemiology,  prevention & control*
Factor Xa / adverse effects*
Female
Follow-Up Studies
Humans
Incidence
Male
Morpholines / administration & dosage*
Predictive Value of Tests
Reproducibility of Results
Risk Factors
Stroke / epidemiology,  prevention & control*
Thiophenes / administration & dosage*
Treatment Outcome
Vitamin K / antagonists & inhibitors*
Warfarin / administration & dosage
Chemical
Reg. No./Substance:
0/Anticoagulants; 0/Morpholines; 0/Thiophenes; 0/rivaroxaban; 12001-79-5/Vitamin K; 81-81-2/Warfarin; EC 3.4.21.6/Factor Xa
Comments/Corrections
Comment In:
Circulation. 2013 Jan 15;127(2):169-71   [PMID:  23319810 ]
Circulation. 2013 Sep 10;128(11):e171   [PMID:  24019451 ]
Ann Intern Med. 2013 Apr 16;158(8):JC13   [PMID:  23588766 ]
Circulation. 2013 Sep 10;128(11):e172-3   [PMID:  24019452 ]

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


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