title: Evaluation of SAMe-TT2R2 score and other clinical factors influencing the quality of anticoagulation therapy in non-valvular atrial fibrillation: a nationwide study in Spain.
abstract: To assess the major clinical factors affecting the quality of anticoagulation and evaluate the predictive value of the SAMe-TT2R2 score to identify patients who will achieve a high average time in therapeutic range (T.T.R.) with vitamin K antagonist (V.K.A.) treatment.
  
  
  
  This observational, cross-sectional, retrospective and nationwide multicenter study included 1524 patients from the primary care setting with non-valvular atrial fibrillation receiving V.K.A. (≥12 months). We performed a bivariate analysis to identify factors individually associated with the T.T.R. and a multiple regression analysis to identify the independent predictive factors. For the validation of the SAMe-TT2R2 score, the receiver operating characteristic (R.O.C.) curve was calculated and the Hosmer-Lemeshow test was used to test calibration.
  
  
  
  A total of 94.8% of patients received acenocumarol (4.8% warfarin). A progressive decrease in mean T.T.R. was found when the SAMe-TT2R2 score increased from 0 points (72.1 ± 17.1%) to 4 points (64.1 ± 23.2%), p < 0.001. Other risk scores (CHADS2 and CHA2DS2-VASc, HAS-BLED) were also associated with the mean T.T.R. We found a significant association between low T.T.R. and the following clinical factors: female sex, three or more comorbidities, amiodarone treatment, dietary habits, bleeding history and the intake of ≥7 tablets per day besides V.K.A. (p < 0.01). Regarding SAMe-TT2R2 score validation, the R.O.C. curve showed significant capability, although not high, of discriminating good anticoagulation control (T.T.R. ≥65%) with an area under the curve of 0.562 (95% C.I. 0.533-0.592, p < 0.001) which increased, remaining modest, to 0.594 (95% C.I. 0.564-0.624, p < 0.001) when the factors not included in SAMe-TT2R2 score were added.
  
  
  
  In this cohort, the SAMe-TT2R2 score had a significant, although modest, ability to assess the likelihood of good international normalized ration (I.N.R.) control, and its predictive value might slightly improve by adding other simple clinical factors. Further research is needed to refine the predictive scales.
authors.affiliation: a Jazmin Primary Care Health Center, East Area Primary Care , Madrid , Spain ;
authors.forename: José M
authors.initials: JM
authors.lastname: Lobos-Bejarano
authors.affiliation: b Cardiology Department , University Hospital Ramon y Cajal , Madrid , Spain ;
authors.forename: Vivencio
authors.initials: V
authors.lastname: Barrios
authors.affiliation: c Primary Care Health Center Casar de Cáceres , Cáceres , Spain ;
authors.forename: José
authors.initials: J
authors.lastname: Polo-García
authors.affiliation: d Cardiology Department , University Hospital La Paz , Madrid , Spain ;
authors.forename: Carlos
authors.initials: C
authors.lastname: Escobar
authors.affiliation: e High Resolution Hospitalization Unit, Hospital el Toyo, Hospital de Poniente El Ejido , Almeria , Spain ;
authors.forename: Diego
authors.initials: D
authors.lastname: Vargas-Ortega
authors.affiliation: f Medical Department , Bayer Hispania , Barcelona , Spain ;
authors.forename: Nuria
authors.initials: N
authors.lastname: Marín-Montañés
authors.affiliation: g Medical Biostatistics, Universidad Católica San Antonio de Murcia , Murcia , Spain ;
authors.forename: Luis
authors.initials: L
authors.lastname: Prieto-Valiente
authors.affiliation: h Primary Care Health Center , Barcelona , Spain ;
authors.forename: Sonia
authors.initials: S
authors.lastname: Fuentes
authors.affiliation: i Vallobín-La Florida Primary Care Health Center , Oviedo , Spain ;|j Medicine Preventive Department , Oviedo University , Asturias , Spain ;
authors.forename: Miguel Angel
authors.initials: MA
authors.lastname: Prieto
authors.affiliation: k Unit of Clinical Research La Alamedilla , Salamanca , Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: García-Ortiz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000453:epidemiology*; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008297:Male; D012372:ROC Curve; D012189:Retrospective Studies; D013030:Spain / Q000453:epidemiology; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D014859:Warfarin
keywords: Anticoagulants; Atrial fibrillation; International normalized ratio; Risk factors; Vitamin K antagonists