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Abstract
Objective: 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. Research design and methods: 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. Results: 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. Conclusion: 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.
Acknowledgments
The authors are very grateful to the investigators and coordinators (Supplemental File 1) of the study because this study would have been impossible without their assistance. The authors would also like to thank C.R.O. Dynamic Solutions for their work, which helped ensure the accuracy and quality of the data collected. We thank Dr. Angel Castellanos Rodriguez for assistance in statistical analysis and Adriana Lopez-Pineda for writing assistance.
Transparency
Declaration of funding
This study was sponsored by an unconditional grant from Bayer Hispania S.L.
Declaration of financial/other relationships
N.M.-M. has disclosed that she is an employee of the Clinical Department of Bayer Hispania S.L. J.M.L.-B., V.B., J.P.-G., C.E., D.V.-O., L.P.-V., S.F., M.A.P., and L.G.-O. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.
C.M.R.O. peer reviewers on this manuscript have no relevant financial or other relationships to disclose.