Evidence of the association between increased use of direct oral anticoagulants and a reduction in the rate of atrial fibrillation-related stroke and major bleeding at the population level (2012–2019) / Evidencia a nivel poblacional de la asociación entre el aumento del uso de anticoagulantes orales directos y una reducción de la incidencia de ictus y hemorragias mayores relacionados con fibrilación auricular (2012-2019)

Background: The introduction of direct-acting oral anticoagulants (DOACs) has shown to decrease atrial fibrillation (AF)-related stroke and bleeding rates in clinical studies, but there is no certain evidence about their effects at the population level. Our aim was to assess changes in AF-related stroke and major bleeding rates between 2012 and 2019 in Andalusia (Spain), and the association between DOACs use and events rates at the population level. Methods: All patients with an AF diagnosis from 2012 to 2019 were identified using the Andalusian Health Population Base, that provides clinical information on all Andalusian people. Annual ischemic and hemorrhagic stroke, major bleeding rates, and used antithrombotic treatments were determined. Marginal hazard ratios (HR) were calculated for each treatment. Results: A total of 95,085 patients with an AF diagnosis were identified. Mean age was 76.1±10.2 years (49.7% women). An increase in the use of DOACs was observed throughout the study period in both males and females (p<0.001). The annual rate of ischemic stroke decreased by one third, while that of hemorrhagic stroke and major bleeding decreased 2–3-fold from 2012 to 2019. Marginal HR was lower than 0.50 for DOACs compared to VKA for all ischemic or hemorrhagic events. Conclusions: In this contemporary population-based study using clinical and administrative databases in Andalusia, a significant reduction in the incidence of AF-related ischemic and hemorrhagic stroke and major bleeding was observed between 2012 and 2019. The increased use of DOACs seems to be associated with this reduction.(AU)

Introducción: La introducción de los anticoagulantes orales de acción directa (ACOD) ha demostrado disminuir las tasas de accidentes cerebrovasculares y hemorragias relacionados con fibrilación auricular (FA) en estudios clínicos, pero no hay tanta evidencia sobre sus efectos a nivel poblacional. Nuestro objetivo fue evaluar los cambios en la incidencia de ictus y hemorragias mayores relacionados con FA entre 2012 y 2019 en Andalucía (España), y estudiar la asociación entre el uso de ACOD y estos eventos a nivel poblacional. Métodos: Se incluyeron pacientes con diagnóstico de FA entre los años 2012 y 2019 en la Base de Población Sanitaria de Andalucía, que proporciona información clínica de todos los andaluces. Se determinaron los accidentes cerebrovasculares isquémicos y hemorrágicos anuales, las tasas de sangrado mayor y los tratamientos antitrombóticos utilizados. Se estimaron los hazard ratio para cada tratamiento. Resultados: Se identificaron un total de 95.085 pacientes con diagnóstico de FA. La edad media fue de 76,1±10,2 años (49,7% mujeres). Se observó un aumento en el uso de ACOD a lo largo del período de estudio, tanto en varones como en mujeres (p<0,001). La tasa anual de ictus isquémico disminuyó en un tercio, mientras que la de ictus hemorrágico y hemorragia mayor se redujo de 2 a 3 veces entre 2012 y 2019. Los hazard ratio fueron inferiores a 0,50 para los ACOD en comparación con los antivitamina K para todos los eventos isquémicos o hemorrágicos. Conclusiones: En este estudio poblacional contemporáneo, se observó, utilizando bases de datos clínicas y administrativas de Andalucía, una reducción significativa en la incidencia de ictus isquémico y hemorrágico, y hemorragia mayor relacionados con FA entre los años 2012 y 2019. El mayor uso de ACOD parece estar asociado con esta reducción.(AU)

Evidence of the association between increased use of direct oral anticoagulants and a reduction in the rate of atrial fibrillation-related stroke and major bleeding at the population level (2012-2019).

BACKGROUND: The introduction of direct-acting oral anticoagulants (DOACs) has shown to decrease atrial fibrillation (AF)-related stroke and bleeding rates in clinical studies, but there is no certain evidence about their effects at the population level. Our aim was to assess changes in AF-related stroke and major bleeding rates between 2012 and 2019 in Andalusia (Spain), and the association between DOACs use and events rates at the population level. METHODS: All patients with an AF diagnosis from 2012 to 2019 were identified using the Andalusian Health Population Base, that provides clinical information on all Andalusian people. Annual ischemic and hemorrhagic stroke, major bleeding rates, and used antithrombotic treatments were determined. Marginal hazard ratios (HR) were calculated for each treatment. RESULTS: A total of 95,085 patients with an AF diagnosis were identified. Mean age was 76.1±10.2 years (49.7% women). An increase in the use of DOACs was observed throughout the study period in both males and females (p<0.001). The annual rate of ischemic stroke decreased by one third, while that of hemorrhagic stroke and major bleeding decreased 2-3-fold from 2012 to 2019. Marginal HR was lower than 0.50 for DOACs compared to VKA for all ischemic or hemorrhagic events. CONCLUSIONS: In this contemporary population-based study using clinical and administrative databases in Andalusia, a significant reduction in the incidence of AF-related ischemic and hemorrhagic stroke and major bleeding was observed between 2012 and 2019. The increased use of DOACs seems to be associated with this reduction.

Valor pronóstico de la fibrosis hepática valorada por el índice FIB4 en pacientes ingresados por síndrome coronario agudo / Prognostic value of liver fibrosis assessed by the FIB-4 index in patients with acute coronary syndrome

Introducción y objetivos: La fibrosis hepática precede a la cirrosis y a la insuficiencia hepática. Las formas subclínicas de fibrosis hepática podrían aumentar el riesgo de eventos cardiovasculares. El objetivo fue describir el valor pronóstico del índice FIB-4 en pacientes con síndrome coronario agudo (SCA) sobre la mortalidad hospitalaria y el pronóstico posterior. Métodos: Estudio retrospectivo de pacientes con SCA en un centro. Los objetivos de análisis fueron la mortalidad en la fase hospitalaria y tras el alta, así como la insuficiencia cardiaca y el sangrado mayor (SM), que se evaluaron tomando como evento competitivo la mortalidad por todas las causas y se presentan los sub-hazard ratios (sHR). Los eventos recurrentes se evaluaron mediante la razón de tasas de incidencia (IRR). Resultados: Se incluyeron a 3.106 pacientes y el 6,66% tenía un índice FIB-4 ≥ 1,3. El análisis multivariado verificó mayor riesgo de mortalidad intrahospitalaria asociado al índice FIB-4 (OR = 1,24; p=0,016) y los pacientes con valores> 2,67 presentaron el doble de riesgo (OR = 2,35; p=0,038). Tras el alta (mediana de seguimiento 1.112 días) el índice FIB-4 no tuvo valor pronóstico de mortalidad pero valores ≥ 1,3 se asociaron a mayor riesgo del primer reingreso (Shr = 1,61; p=0,04) o recurrente (IRR =1,70; p=0,001) de IC. El índice FIB-4 ≥ 1,30 se asoció con mayor riesgo de SM (sHR = 1,62; p=0,030). Conclusiones: La evaluación de la fibrosis hepática por el índice FIB-4 identifica a los pacientes con SCA con mayor riesgo de mortalidad intrahospitalaria pero también con mayor riesgo de IC y SM tras el alta.(AU)

Introduction and objectives: Liver fibrosis is present in nonalcoholic liver disease (NAFLD) and both precede liver failure. Subclinical forms of liver fibrosis might increase the risk of cardiovascular events. The objective of this study was to describe the prognostic value of the FIB-4 index on in-hospital mortality and postdischarge outcomes in patients with acute coronary syndrome (ACS). Methods: Retrospective study including all consecutive patients admitted for ACS between 2009 and 2019. According to the FIB-4 index, patients were categorized as <1.30, 1.30-2.67 or> 2.67. Heart failure (HF) and major bleeding (MB) were assessed taking all-cause mortality as a competing event and subhazard ratios (sHR) are presented. Recurrent events were evaluated by the incidence rate ratio (IRR). Results: We included 3106 patients and 6.66% had a FIB-4 index ≥ 1.3. A multivariate analysis verified a higher risk of in-hospital mortality associated with the FIB-4 index (OR, 1.24; P=.016). Patients with a FIB-4 index> 2.67 had a 2-fold higher in-hospital mortality risk (OR, 2.35; P=.038). After discharge (median follow-up 1112 days), the FIB-4 index had no prognostic value for mortality. In contrast, patients with FIB-4 index ≥ 1.3 had a higher risk of first (sHR, 1.61; P=.04) or recurrent (IRR, 1.70; P=.001) HF readmission. Similarly, FIB-4 index ≥ 1.30 was associated with a higher MB risk (sHR, 1.62; P=.030). Conclusions : The assessment of liver fibrosis by the FIB-4 index identifies ACS patients not only at higher risk of in-hospital mortality but also at higher risk of HF and MB after discharge.(AU)

Prognostic value of liver fibrosis assessed by the FIB-4 index in patients with acute coronary syndrome.

INTRODUCTION AND OBJECTIVES: Liver fibrosis is present in nonalcoholic liver disease (NAFLD) and both precede liver failure. Subclinical forms of liver fibrosis might increase the risk of cardiovascular events. The objective of this study was to describe the prognostic value of the FIB-4 index on in-hospital mortality and postdischarge outcomes in patients with acute coronary syndrome (ACS). METHODS: Retrospective study including all consecutive patients admitted for ACS between 2009 and 2019. According to the FIB-4 index, patients were categorized as <1.30, 1.30-2.67 or> 2.67. Heart failure (HF) and major bleeding (MB) were assessed taking all-cause mortality as a competing event and subhazard ratios (sHR) are presented. Recurrent events were evaluated by the incidence rate ratio (IRR). RESULTS: We included 3106 patients and 6.66% had a FIB-4 index ≥ 1.3. A multivariate analysis verified a higher risk of in-hospital mortality associated with the FIB-4 index (OR, 1.24; P=.016). Patients with a FIB-4 index> 2.67 had a 2-fold higher in-hospital mortality risk (OR, 2.35; P=.038). After discharge (median follow-up 1112 days), the FIB-4 index had no prognostic value for mortality. In contrast, patients with FIB-4 index ≥ 1.3 had a higher risk of first (sHR, 1.61; P=.04) or recurrent (IRR, 1.70; P=.001) HF readmission. Similarly, FIB-4 index ≥ 1.30 was associated with a higher MB risk (sHR, 1.62; P=.030). CONCLUSIONS: The assessment of liver fibrosis by the FIB-4 index identifies ACS patients not only at higher risk of in-hospital mortality but also at higher risk of HF and MB after discharge.

Tromboprofilaxis en pacientes hospitalizados: implementación de un programa multifacético / Thromboprophylaxis in hospitalized patients: implementation of a multifacetical program

Resumen La enfermedad tromboembólica venosa es la causa prevenible más frecuente de muerte hospitalaria. A pesar de contar con evidencia y recomendaciones sobre la utilidad de la tromboprofilaxis, la adherencia por parte de los médicos a las mismas es muy variable, y frecuentemente subóptima. El objetivo de este estudio fue evaluar un programa institucional con estrategias multifacéticas dirigido a médicos, sobre tromboprofilaxis en internación y estimar el cambio en la adecuación de la tromboprofilaxis antes y después de la intervención. La intervención se mantuvo durante 6 años, fue múltiple, utilizando acciones pasivas como car telería, y activas, como educación médica continua, confección y adopción de una guía institucional de práctica clínica y un sistema de soporte informático para la decisión clínica. La adecuación basal de la tromboprofilaxis mejoró de 59% a 82% después de la intervención y se mantuvo en el tiempo. La mejora en la adecuación se asoció a una reducción de los sangrados mayores, en particular en pacientes intervenidos quirúrgicamente.

Abstract Venous thromboembolic disease is the most common preventable cause of hospital death. Despite the existence of evidence of the usefulness of thromboprophylaxis and recommendations, adherence by physicians to them is highly variable, and frequently suboptimal. The objective was to evaluate the change in the adequacy of thromboprophylaxis before and after an intervention on thromboprophylaxis with multifaceted strategies for physicians. The intervention was a 6 years institutional program with multiple strategies: passive actions such as posters and active actions as continuous medical education, adaptation of an institutional clinical practice guide and a computerized clinical decision support system. The baseline adequacy of thromboprophylaxis improved from 59% to 82% and was maintained over time. The improvement in fitness was associated with a reduction in major bleeding, particularly in patients undergoing surgery.

Safety of oral anticoagulants in advanced chronic kidney disease / Seguridad de los anticoagulantes orales en enfermedad renal crónica avanzada

Abstract Background: patients who take long-term oral anticoagulants and also have CKD have a greater probability of bleeding. Methods: a retrospective, descriptive cohort study reviewing the clinical charts of anticoagulated patients with Stage 3 CKD or above seen at an anticoagulation clinic, in order to evaluate hemorrhagic events and baseline characteristics of the population over a two-year period. Results: 238 patients were included. The anticoagulants used were warfarin (45%), rivaroxaban (31.5%), apixaban (14.3%) and dabigatran (3.4%). According to the KDIGO classification, 78% of the patients had CKD G3 (37.3% G3a and 40.7% G3b), 15.9% G4 and 5.8% G5 with renal replace ment therapy (RRT). During the study period, only 20 patients (8.4%) had hemorrhagic events; of these, seven (35%) were major (four associated with warfarin, two with rivaroxaban and one with apixaban). The other 13 bleeds were minor and associated with warfarin in 46.1% of the cases. Gastrointestinal bleeding was the most common (35%), followed by soft tissues (30%). There was only one fatal bleed, which occurred in the central nervous system (CNS) in a patient with CKD G4. Conclusion: a low rate of bleeding was found, which could be related to close follow up by an anticoagulation clinic. The anticoagulant most frequently associated with bleeding was warfarin, which could be related to a low time in therapeutic range (48.8%). Due to the low rate of events, comparisons could not be made. (Acta Med Colomb 2021; 46. DOI: https://doi.org/10.36104/amc.2021.1945).

Resumen Antecedentes: los pacientes que toman anticoagulantes orales a largo plazo y además cursan con enfermedad renal crónica (ERC), tienen mayor probabilidad de tener sangrados. Métodos: estudio de cohorte descriptivo retrospectivo en el cual se revisaron historias clínicas de pacientes anticoagulados y con ERC 3 en adelante, atendidos en una clínica de anticoagulación con el fin de evaluar eventos hemorrágicos y características básales de la población en un periodo de dos años Resultados: se incluyeron 238 pacientes. Los anticoagulantes usados fueron warfarina (45%), rivaroxabán (31.5%), apixabán (14.3%) y dabigatrán (3.4%). Según la clasificación KDIGO 78% de los pacientes tenían ERC G3 (37.3% G3a y 40.7% G3b), 15.9% G4 y 5.8% G5 con terapia de reemplazo renal (TRR). En el periodo de estudio solo 20 pacientes (8.4%) tuvieron eventos hemo rrágicos, de estos, 7 (35%) fueron mayores (cuatro asociados a warfarina, dos rivaroxabán y uno apixabán). Los otros 13 sangrados fueron menores y asociados a warfarina en 46.1% de los casos. El sangrado digestivo fue el más frecuente (35%), seguido por tejidos blandos (30%). Sólo hubo un sangrado fatal el cual se dio en sistema nervioso central (SNC) en un paciente con ERC G4. Conclusión: se apreció una baja tasa de sangrado, lo que podría estar relacionado con el estrecho seguimiento de una clínica de anticoagulación. El anticoagulante que más frecuentemente se asoció con sangrado fue warfarina, lo cual puede estar relacionado con un bajo tiempo en rango terapéutico (48.8%). Por la baja tasa de eventos, no fue posible la realización de comparaciones. (Acta Med Colomb 2021; 46. DOI: https://doi.org/10.36104/amc.2021.1945).

Surgical site infection in adults undergoing major non-cardiac surgery and its association with anemia, El severe bleeding and intraoperative transfusion: A preliminary report from a prospective registry / Infección de sitio operatorio en adultos llevados a cirugía mayor no cardiaca y su relación con anemia, sangrado mayor y transfusión intraoperatoria: Informe preliminar de un registro prospectivo

Abstract Introduction: Surgical site infection (SSI) is among the most common healthcare-related infections. Given their greater morbidity and surgical complexity, patients undergoing major surgery are exposed to a high risk of SSI. Objective: To determine the incidence of SSI in adult patients undergoing major elective non-cardiac surgery, and to identify risk factors associated with its occurrence within the first 30 days after surgery. Methods: An analytical study was designed on the basis of a prospective institutional registry. Clinical and laboratory variables associated with perioperative management were recorded. An active search was conducted in order to find SSI episodes, renal failure and multiple organ dysfunction during the first 30 days after surgery. Adjusted logistic regression was done to identify potential associations between risk factors and the development of SSI. Results: Overall, 1501 patients were included. The incidence of SSI during the first 30 days after surgery was 6.72% (95% CI 5.57-8.11). ASA III, abdominal surgery and longer procedures were more frequent in the SSI group. Association with the occurrence of SSI was documented for preoperative hemoglobin levels (adjusted OR 0.79 [95% CI 0.72-0.88], p = 0.04), intraoperative transfusion (adjusted OR 2,47 [95% CI 1.16-5.27], p = 0.02) and major blood loss (adjusted OR 3.80 [95% CI 1.63-8.88], p = 0.04). Conclusion: Preoperative hemoglobin level, intraoperative transfusion and major bleeding are independent risk factors associated with the occurrence of SSI in adult patients undergoing major elective non-cardiac surgery.

Resumen Introducción: La infección del sitio operatorio (ISO) ocupa los primeros lugares entre las infecciones asociadas a la atención en salud. Con una mayor morbilidad y complejidad quirúrgica, los pacientes de cirugía mayor están expuestos a un alto riesgo de ISO. Objetivo: Determinar la incidencia de ISO en pacientes adultos sometidos a cirugía mayor electiva no cardiaca e identificar factores de riesgo relacionados con su aparición durante los primeros 30 días postoperatorios. Métodos: Se diseñó un estudio analítico a partir de un registro institucional prospectivo. Se registraron variables clínicas y de laboratorio relacionadas con el manejo perioperatorio. Se realizó una búsqueda activa de episodios de ISO, sepsis, falla renal y disfunción multiorgánica durante los primeros 30 días postoperatorios. Las potenciales asociaciones entre factores de riesgo y el desarrollo de ISO fueron identificadas mediante regresión logística ajustada. Resultados: Se incluyeron 1.501 pacientes. La incidencia de ISO durante los 30 días postoperatorios fue de 6,72 % [IC 95 % 5,57-8,11). El estado ASA III, la cirugía abdominal y los procedimientos de duración prolongada fueron más frecuentes en el grupo ISO. Se documentó asociación con la ocurrencia de ISO para los niveles de hemoglobina preoperatoria (OR ajustado 0,79 [IC 95 % 0,72-0,88], p = 0,04), transfusión intraoperatoria (OR ajustado 2,47 [IC 95 % 1,16-5,27], p = 0,02) y sangrado mayor intraoperatorio (OR ajustado 3,80 [IC 95 % 1,63-8,88], p = 0,04). Conclusiones: El nivel de hemoglobina preoperatoria, la transfusión intraoperatoria y el sangrado mayor son factores de riesgo asociados de forma independiente a la ocurrencia de ISO en pacientes adultos llevados a cirugía mayor electiva no cardiaca.

Prognosis of venous thromboembolism in orthopaedic surgery or trauma patients and use of thromboprophylaxis. / Pronóstico de la enfermedad tromboembólica venosa en cirugía ortopédica o pacientes traumatológicos y uso de tromboprofilaxis.

BACKGROUND: There is scarce evidence about the prognosis of venous thromboembolism in patients undergoing orthopedic surgery and in patients suffering non-surgical trauma. METHODS: We used the RIETE database (Registro Informatizado de pacientes con Enfermedad Trombo Embólica) to compare the prognosis of venous thromboembolism and the use of thromboprophylaxis in patients undergoing different orthopedic procedures and in trauma patients not requiring surgery. RESULTS: From March 2001 to March 2015, a total of 61,789 patients were enrolled in RIETE database. Of these, 943 (1.52%) developed venous thromboembolism after elective arthroplasty, 445 (0.72%) after hip fracture, 1,045 (1.69%) after non-major orthopedic surgery and 2,136 (3.46%) after non-surgical trauma. Overall, 2,283 patients (50%) initially presented with pulmonary embolism. Within the first 90 days of therapy, 30 patients (0.66%; 95% CI 0.45-0.93) died from pulmonary embolism. The rate of fatal pulmonary embolism was significantly higher after hip fracture surgery (n = 9 [2.02%]) than after elective arthroplasty (n = 5 [0.53%]), non-major orthopedic surgery (n = 5 [0.48%]) or non surgical trauma (n = 11 [0.48%]). Thromboprophylaxis was more commonly used for hip fracture (93%) or elective arthroplasty (94%) than for non-major orthopedic surgery (71%) or non-surgical trauma (32%). Major bleeding was significantly higher after hip fracture surgery (4%) than that observed after elective arthroplasty (1.6%), non-major orthopedic surgery (1.5%) or non-surgical trauma (1.4%). CONCLUSIONS: Thromboprophylaxis was less frequently used in lower risk procedures despite the absolute number of fatal pulmonary embolism after non-major orthopedic surgery or non-surgical trauma, exceeded that observed after high risk procedures.