Evaluación de la calidad de la anticoagulación y del riesgo cardiovascular en pacientes con fibrilación auriculardatos en vida real del registro FANTASIIA

Abstract

Background: The efficacy and safety of oral anticoagulation therapy with vitamin K antagonists (VKA) in Atrial Fibrillation (AF) patients is related with the quality of anticoagulation control, reflected as the average percentage of the time in therapeutic range (TTR). There are several conditions that could affect this quality of anticoagulation control as the presence of chronic kidney disease (CKD). The SAMe-TT2R2 score is a clinical tool to predict the quality of anticoagulation with VKA. Indeed, it is important to assess the cardiovascular and bleeding risk of AF patients. Recently, 2 new scores have been proposed: the ORBIT score and the 2MACE score. Objectives: 1) To analyze the clinical determinants of quality of oral anticoagulation therapy and to explore the predictive role of anticoagulation control based on different definitions of "good anticoagulation control" in AF patients under stable VKA therapy. To determinate the relationship between clinical determinants of quality of anticoagulation and adverse clinical events. 2) To validate the SAMe-TT2R2 score to predict the quality of anticoagulation therapy. 3) To analyze the clinical characteristics, the incidence of cardiovascular events in AF patients with CKD and to compare the different formulas to estimate the glomerular filtration rate. 4) To validate the predictive performance of ORBIT and HAS-BLED bleeding scores for mortality and major bleeding. 5) To investigate the incidence of non-embolic adverse events in AF patients and to validate the 2MACE score. 6) To estimate the potential absolute benefit in clinical outcome rates if the AF patients anticoagulated with VKA therapy had been treated with NOACs. Methods: All AF patients included in the prospective multicenter FANTASIIA registry were analyzed. Baseline clinical and demographic characteristics and adverse events after 1 year of follow-up were analyzed. The quality of anticoagulation was assessed with the TTR estimated by Rosendaal, the TTR estimated by direct method. Indeed, all AF patients were classified according to the degree of renal dysfunction in 4 stages and the 4 different formulas to estimate the glomerular filtration rate were also compared. The predictive performance of different risk scores: SAMe-TT2R2 score, ORBIT score, HAS-BLED score and 2 MACE score were evaluated. After the analysis of the results, the conclusions were: 1A) 55% of AF patients treated with VKA had poor anticoagulation control. Diabetes Mellitus, peripheral artery disease and HAS-BLED score were independently related with poor anticoagulation control (TTR<70%). 1B) There was a high correlation between Rosendaal and direct method (percentage of INRs within therapeutic range) to assess TTR. 2) This is the first time that SAMe-TT2R2 score >2 is validated prospectively in a multicenter cohort of patients treated with acenocoumarol for predicting TTR <70%. 3A) About 67% of patients with AF and severe CKD had poor anticoagulation control whilst taking VKA. 3B) The worsening of only 10 ml/min in the glomerular filtration rate during the follow-up was significantly associated with mortality and major bleeding. 4) The FANTASIIA registry is the first external validation of ORBIT score and this bleeding score was not superior to HAS-BLED score for predicting major bleeding and mortality. 5) In the FANTASIIA registry, it has been performed the first external prospective validation of 2MACE score to predict cardiovascular events in AF patients where 2MACE > or = 3 had the best sensitivity and specificity in identifying patients at high risk of MACE. 6) The estimated absolute effect of the use of NOACs in the population treated with VKAs showed a reduction in adverse events (major bleeding and mortality), specially with Apixaban and Dabigatran 150 mg.