title: Development and validation of cardiovascular risk scores for haemodialysis patients.
abstract: BACKGROUND
  A simple clinical tool to predict cardiovascular disease risk does not exist for haemodialysis patients. The long-term coronary risk Framingham Heart Study Risk score (FRS), although used in this population, may be inadequate. Therefore, we developed separate risk-scores for cardiovascular mortality (CVM) and cardiovascular morbidity & mortality (CVMM) in a Fresenius Medical Care-based haemodialysis patient cohort (AROii).
  
  
  METHODS
  Applying a modified FRS approach, we derived and internally validated two-year risk-scores in incident European adult patients randomly assigned to a development (N=4831) or a validation (N=4796) dataset. External validation was conducted in the third Dialysis Outcomes and Practice Patterns Study (DOPPS III) cohort. Additional discrimination comparing to the FRS was performed.
  
  
  RESULTS
  The overall two-year CVM and CVMM event rates were 5.0 and 22.6 per 100 person-years respectively. Common risk predictors included increasing age, cardiovascular disease history, primary diabetic nephropathy, low blood pressure, and inflammation. The CVM score was more predictive in AROii (c-statistic 0.72) and in DOPPS III (c-statistic 0.73-0.74) than the CVMM score (c-statistic 0.66-0.67 & 0.63 respectively). The FRS was not predictive of either CVM (c-statistic 0.54) or CVMM (c-statistic 0.56) in AROii.
  
  
  CONCLUSIONS
  We describe novel, easy-to-apply and interpret CV risk-scores for haemodialysis patients. Our improved cardiovascular prediction performance over traditional (FRS) scores reflected its tailored development and validation in haemodialysis populations, and the integration of non-classical cardiovascular risk factors. The lower expected versus observed CVM and CVMM risk suggests the existence of novel cardiovascular risk factors in this patient population not measured in this study.
authors.affiliation: Innovative Clinical Trials, Department of Cardiology & Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany.
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.affiliation: Center for Observational Research (CfOR), Amgen Ltd., Uxbridge, United Kingdom.
authors.forename: Iain A
authors.initials: IA
authors.lastname: Gillespie
authors.affiliation: Nephrology and Hypertension, University of Erlangen-Nuremberg, Germany.
authors.forename: Kai-Uwe
authors.initials: KU
authors.lastname: Eckardt
authors.affiliation: Division of Genetic Epidemiology, Department of Medical Genetics, Molecular and Clinical Pharmacology, Medical University of Innsbruck, Innsbruck, Austria.
authors.forename: Florian
authors.initials: F
authors.lastname: Kronenberg
authors.affiliation: Global Biostatistics, Amgen Ltd., Uxbridge, United Kingdom.
authors.forename: Sharon
authors.initials: S
authors.lastname: Richards
authors.affiliation: Inserm U 1018, Paul Brousse Hospital, Paris Sud University, Villejuif, France.
authors.forename: Tilman B
authors.initials: TB
authors.lastname: Drueke
authors.affiliation: Department of Renal Medicine, Karolinska University Hospital Huddinge, Stockholm, Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Stenvinkel
authors.affiliation: Arbor Research Collaborative for Health, Ann Arbor, MI, United States.
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Pisoni
authors.affiliation: Arbor Research Collaborative for Health, Ann Arbor, MI, United States.
authors.forename: Bruce M
authors.initials: BM
authors.lastname: Robinson
authors.affiliation: EMEALA Medical Board, Fresenius Medical Care, Bad Homburg, Germany and Danube University, Krems, Austria.
authors.forename: Daniele
authors.initials: D
authors.lastname: Marcelli
authors.affiliation: International Development Nephrology, Amgen Europe GmbH, Zug, Switzerland;
authors.forename: Marc
authors.initials: M
authors.lastname: Froissart
authors.affiliation: Nephrology, RWTH University of Aachen, Aachen, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Floege
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000401:mortality; D015331:Cohort Studies; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D006435:Renal Dialysis / Q000009:adverse effects / Q000401:mortality*; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D044465:White People / Q000706:statistics & numerical data
keywords: Cardiovascular disease; Framingham; Nephrology; Risk prediction; Validation