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      Utilidad del score SAMe-TT2R2 en el control de la anticoagulación oral con warfarina en pacientes con fibrilación auricular no valvular Translated title: Usefulness of the SAMe-TT2R2 score in the control of oral anticoagulation with warfarin in patients with non-valvular atrial fibrillation

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          Abstract

          Antecedentes: la prevención de eventos tromoboembólicos mediante anticoagulación oral es uno de los principales objetivos en el tratamiento de la fibrilación auricular (FA) no valvular, pudiendo utilizarse tanto fármacos antivitamina K (AVK), como warfarina y anticoagulantes orales directos (ACOD). La warfarina ofrece su mayor eficacia y seguridad cuando el porcentaje de tiempo en rango terapéutico (TTR) es mayor de 65%-70%. El score SAMe-TT2R2 fue desarrollado como herramienta para intentar predecir la respuesta al tratamiento anticoagulante con fármacos AVK. Los pacientes con un puntaje favorable (0-1 punto) tendrían una buena respuesta al tratamiento y por lo tanto un TTR adecuado, mientras que un puntaje desfavorable (2 puntos) permitiría predecir un TTR inadecuado, identificando pacientes que requieren intervenciones adicionales para optimizar la calidad de anticoagulación o que serían mejores candidatos a ACOD. Objetivo: evaluar la utilidad del score SAMe-TT2R2 en el control de la anticoagulación oral con warfarina en pacientes portadores de FA no valvular. Método: estudio retrospectivo de 115 pacientes ambulatorios con FA no valvular, anticoagulados con warfarina entre el 1° de junio de 2012 y el 31 de junio de 2014. Las variables analizadas fueron: edad, sexo, fracción de eyección del ventrículo izquierdo (FEVI), comorbilidades, fármacos concomitantes, score CHA2DS2-VASc y HAS-BLED. Se calculó el TTR individual mediante método de Rosendaal y se calculó el score SAMe-TT2R2. Se utilizó el test de t para comparación de medias y el test de chi² para análisis de variables categóricas. Se consideró significativo un valor p<0,05. Resultados: la media de edad fue de 71,0±9,8 años, sexo masculino 52,2%. Comorbilidades asociadas fueron: hipertensión arterial (HTA) 82,6%, cardiopatía isquémica 24,3%, diabetes mellitus 18,3%, ataque cerebrovascular previo 10,4%, tabaquismo 6,1% y ex tabaquista 30,4%, consumo concomitante de tres o más fármacos 87,0%. La media de FEVI fue de 48,3±12,4%, score CHA2DS2-VASc 3,6±1,2 puntos y score HAS-BLED 1,8±0,9 puntos. La media de TTR calculada fue de 54,9±21,6% y solamente 37 pacientes (32,2%) tuvieron un TTR 65%. El score SAMe-TT2R2 tuvo una media de 1,8±1,0 puntos, 45 pacientes (39,1%) tuvieron un puntaje favorable a warfarina (0-1 punto) y 70 pacientes (60,9%) un puntaje desfavorable (2 puntos). No hubo diferencia significativa en la media de TTR según la categoría de SAMe-TT2R2 (53,0±23,7% vs 56,2±20,2%, p=0,447). Tampoco se encontró asociación entre un score SAMe-TT2R2 favorable a warfarina y un TTR 65% (33,3% vs 31,4%, p=0,831). Conclusión: en la población estudiada no hubo diferencia en la calidad de la anticoagulación oral con warfarina entre las categorías (favorable y desfavorable) del score SAMe-TT2R2.

          Translated abstract

          Background: prevention of thromboembolic events is the main objective of oral anticoagulation treatment in non-valvular atrial fibrillation (AF) and either oral anticoagulation with vitamin K antagonists (VKA), like warfarin, or direct oral anticoagulants (ACOD) can be used. When warfarin is used, a time in therapeutic range (TTR) >65- 70% offers the best efficacy and safety. The SAMe-TT2R2 score has been developed as a tool to predict the response to VKA. A favorable SAMe-TT2R2 score (0-1 point) can identify patients that respond adequately to VKA and will have a better TTR, whilst a not favorable SAMe-TT2R2score (2 points) associates with poor TTR, needing additional therapies to optimize anticoagulation quality control or would be better candidates to direct oral anticoagulants (ACOD) Objective: assess SAMe-TT2R2 score value in anticoagulation quality control of patients with non-valvular AF treated with warfarin. Method: retrospective study of 115 ambulatory patients with non-valvular AF receiving oral anticoagulation treatment with warfarin, from June 1st 2012 to June 31st 2014. Analyzed variables were age, sex, left ventricle ejection fraction (LVEF), comorbidities, number of concomitant drugs, CHA2DS2-VASc and HAS-BLED scores. Rosendaal method was used to calculate the individual TTR. Student T test was used to compare mean values and X2 test for categorical variables. P < 0.05 was considered statistically significant. Results: mean age was 71.0 ± 9.8 years, 52.2% were male, most frequent comorbidities were: hypertension 82.6%, ischemic heart disease 24.3%, diabetes mellitus 18.3%, cerebrovascular disease 10.4%, smoking 6.1% and former smoking 30.4%, concomitant use of 3 or more drugs 87%. Mean LVEF was 48.3 ± 12.5 %, CHA2DS2-VASc Score 3.6 ± 1.2 points and HAS-BLED Score 1.8 ± 0.9 points. Mean TTR was 54.9 ± 21.6% and only 37 patients (32.2%) had a TTR 65%. Mean SAMe-TT2R2 score was 1.8 ± 1.0 points, a warfarin-favorable score (0-1 point) was found in 45 patients (39.1%) and 70 patients (60.9%) had a non-favorable score (2 points). No significant mean TTR difference was found among SAMe-TT2R2 categories (53.0 ± 23.7% vs. 56.2 ± 20.2%, p=0.447). No association between a favorable SAMe-TT2R2 Score and a high TTR (65%) was found (33.3 vs. 31.4%, p=0.831). Conclusion: no difference in anticoagulation quality control was found among favorable and non-favorable SAMe-TT2R2 score categories.

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          Most cited references 54

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          Dabigatran versus warfarin in patients with atrial fibrillation.

          Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P=0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P=0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P=0.13) and 3.64% per year with 150 mg of dabigatran (P=0.051). In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.) 2009 Massachusetts Medical Society
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            Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.

            The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.).
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              Apixaban versus Warfarin in Patients with Atrial Fibrillation

              Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42). In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                ruc
                Revista Uruguaya de Cardiología
                Rev.Urug.Cardiol.
                Sociedad Uruguaya de Cardiología (Montevideo, , Uruguay )
                0797-0048
                1688-0420
                December 2016
                : 31
                : 3
                : 381-389
                Affiliations
                Montevideo orgnameHospital de Clínicas orgdiv1Centro Cardiovascular Universitario orgdiv2Unidad Multidisciplinaria de Insuficiencia Cardíaca Uruguay
                Article
                S1688-04202016000300004

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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