Population attitude and access to the healthcare system during the COVID-19 pandemic / Actitud de la población y acceso al sistema de salud durante la pandemia de COVID-19

Abstract The COVID-19 pandemic elicited important changes in community habits and behaviors, including a distancing of people from the healthcare system. The objective of this work was to understand the causes that gave rise to changes in behavior from an individual perspective in the Argentine Republic. We performed a cross-sectional, web-based survey using an online questionnaire. The survey was distributed via the WhatsApp application for smartphones among subjects across the Argentine territory using a combination of convenience and snowball sampling. We received 6176 responses. Almost 70% of respondents manifested fear of visiting a physician. One third of respondents manifested having a desire or need in at least one occasion of visiting a physician but, of these, 48% avoided it. The main reasons for avoiding visits were: 1) a recommenda tion of staying home (40%); 2) lack of access to the physician (35%); and 3) fear of contagion (26%). The most common form of consultation was through unconventional means (e-mail, telephone, or WhatsApp). One of 5 respondents had difficulties to obtain a medication prescription and 5% stopped the use of at least one medica tion. Regarding healthy habits, almost 2/3 of those surveyed stated that they became more sedentary; 11% of hypertensive patients increased their consumption of salt and 15% saw their blood pressure values increase, while 16% of dyslipidemic patients showed increased consumption of fats.

Resumen La pandemia de COVID-19 determinó un importante cambio de los hábitos y comportamientos comu nitarios, entre ellos se observó un distanciamiento de la gente del sistema de salud y el abandono de hábitos saludables. El objetivo de este trabajo fue comprender las causas que dieron lugar a dichos cambios de com portamiento desde una perspectiva individual y evaluar el impacto en el control de los factores de riesgo car diovasculares. Realizamos una encuesta utilizando un cuestionario en línea y distribuida mediante la aplicación WhatsApp entre personas de la Argentina utilizando una combinación de muestreo por conveniencia y en "bola de nieve". Recibimos 6176 respuestas, casi el 70% de los encuestados manifestaron temor de realizar una con sulta médica. Un tercio de los encuestados manifestó haber tenido necesidad de ir al médico en al menos una oportunidad desde el inicio de la pandemia, pero de éstos, el 48% evitó la visita. Las principales razones para evitarla: 1) la recomendación de quedarse en casa (40%); 2) dificultad para acceder al sistema de salud (35%); y 3) miedo al contagio (26%). La forma de consulta más común fue a través de medios no convencionales (correo electrónico, teléfono o WhatsApp). Uno de cada 5 encuestados tuvo dificultades para obtener una receta y el 5% dejó de tomar al menos un medicamento. En cuanto a los hábitos saludables, casi 2/3 de los encuestados afirmaron volverse más sedentarios, el 11% de los hipertensos aumentó su consumo de sal y el 15% aumentó sus valores de presión arterial, mientras que el 16% de los dislipidémicos mostró un mayor consumo de grasas.

Population attitude and access to the healthcare system during the COVID-19 pandemic.

The COVID-19 pandemic elicited important changes in community habits and behaviors, including a distancing of people from the healthcare system. The objective of this work was to understand the causes that gave rise to changes in behavior from an individual perspective in the Argentine Republic. We performed a cross-sectional, web-based survey using an online questionnaire. The survey was distributed via the WhatsApp application for smartphones among subjects across the Argentine territory using a combination of convenience and snowball sampling. We received 6176 responses. Almost 70% of respondents manifested fear of visiting a physician. One third of respondents manifested having a desire or need in at least one occasion of visiting a physician but, of these, 48% avoided it. The main reasons for avoiding visits were: 1) a recommendation of staying home (40%); 2) lack of access to the physician (35%); and 3) fear of contagion (26%). The most common form of consultation was through unconventional means (e-mail, telephone, or WhatsApp). One of 5 respondents had difficulties to obtain a medication prescription and 5% stopped the use of at least one medication. Regarding healthy habits, almost 2/3 of those surveyed stated that they became more sedentary; 11% of hypertensive patients increased their consumption of salt and 15% saw their blood pressure values increase, while 16% of dyslipidemic patients showed increased consumption of fats.

La pandemia de COVID-19 determinó un importante cambio de los hábitos y comportamientos comunitarios, entre ellos se observó un distanciamiento de la gente del sistema de salud y el abandono de hábitos saludables. El objetivo de este trabajo fue comprender las causas que dieron lugar a dichos cambios de comportamiento desde una perspectiva individual y evaluar el impacto en el control de los factores de riesgo cardiovasculares. Realizamos una encuesta utilizando un cuestionario en línea y distribuida mediante la aplicación WhatsApp entre personas de la Argentina utilizando una combinación de muestreo por conveniencia y en "bola de nieve". Recibimos 6176 respuestas, casi el 70% de los encuestados manifestaron temor de realizar una consulta médica. Un tercio de los encuestados manifestó haber tenido necesidad de ir al médico en al menos una oportunidad desde el inicio de la pandemia, pero de éstos, el 48% evitó la visita. Las principales razones para evitarla: 1) la recomendación de quedarse en casa (40%); 2) difi cultad para acceder al sistema de salud (35%); y 3) miedo al contagio (26%). La forma de consulta más común fue a través de medios no convencionales (correo electrónico, teléfono o WhatsApp). Uno de cada 5 encuestados tuvo dificultades para obtener una receta y el 5% dejó de tomar al menos un medicamento. En cuanto a los hábitos saludables, casi 2/3 de los encuestados afirmaron volverse más sedentarios, el 11% de los hipertensos aumentó su consumo de sal y el 15% aumentó sus valores de presión arterial, mientras que el 16% de los dislipidémicos mostró un mayor consumo de grasas.

RACCOVID-19: primer Registro Argentino de Complicaciones Cardiovasculares en pacientes con COVID-19 / RACCOVID-19: First Argentine Registry of Cardiovascular Complications in COVID-19 Patients

RESUMEN Introducción: La enfermedad por coronavirus (COVID-19) ha causado una de las mayores pandemias conocidas al día de la fecha. La Sociedad Argentina de Cardiología (SAC) y la Federación Argentina de Cardiología (FAC) elaboraron el primer Registro Argentino de Complicaciones Cardiovasculares en pacientes con COVID-19 (RACCOVID-19), con el propósito de relevar, a nivel nacional, su impacto en la evolución hospitalaria de estos pacientes. Objetivos: Documentar la aparición de complicaciones cardiovasculares en pacientes internados por COVID-19 y evaluar predictores de riesgo de dichas complicaciones y su impacto pronóstico. Material y Métodos: Se incluyen datos de 2750 pacientes en 50 centros de 11 provincias del país, desde el 18 de mayo hasta el 31 de octubre de 2020. Resultados: La edad promedio fue de 57±18 años y hubo predominio de sexo masculino (60,2%). La tasa de complicaciones cardiovasculares fue del 15,3%. La insuficiencia cardíaca (43,5%), las arritmias (33,5%) y el daño miocárdico (31,1%) fueron las complicaciones más frecuentes. La mortalidad fue del 19,3%. Un modelo de predicción de sobrevida en la etapa hospitalaria incluyó las siguientes variables: edad, sexo masculino, valores de hematocrito y creatinina al ingreso, existencia de antecedentes patológicos, formas de presentación de COVID-19 graves y presencia de complicaciones cardiovasculares. Conclusiones: El registro RACCOVID-19 mostró una tasa de complicaciones cardiovasculares del 15,3%. La mortalidad total del registro fue del 19,3% y las complicaciones cardiovasculares junto con otras variables de presentación, así como la gravedad del cuadro clínico de COVID-19, forman parte de un perfil de riesgo clínico asociado a mayor mortalidad.

ABSTRACT Background: Coronavirus disease (COVID-19) has caused one of the largest pandemics known to date. The Argentine Society of Cardiology (SAC) and the Argentine Federation of Cardiology (FAC) have developed the First Argentine Registry of Cardiovascular Complications in COVID-19 patients (RACCOVID-19) with the purpose of performing a nationwide review of their impact in the in-hospital evolution of these patients. Objectives: The aim of this study was to record cardiovascular complications in hospitalized patients for COVID-19, and to evaluate risk predictors of these complications and their prognostic impact. Methods: A total of 2750 patients from 50 centers in 11 provinces of the country were included from May 18 to October 31, 2020. Results: Mean age was 57±18 years, with a prevalence of male gender (60.2%). Cardiovascular complications occurred in 15.3% of cases. Heart failure (43.5%), arrhythmias (33.5%) and myocardial injury (31.1%) were the most relevant complications. Mortality was 19.3%, and a predictive model of in-hospital survival included age, male gender, admission hematocrit and creatinine, history of previous diseases, severe forms of COVID-19 presentation and cardiovascular complications. Conclusions: The RACCOVID-19 registry showed 15.3% of cardiovascular complications. Overall mortality was 19.3% and cardiovascular complications together with other presentation variables as well as the clinical severity of COVID-19, are part of a clinical risk profile associated with higher mortality.

Discontinuación de la anticoagulación y sus factores asociados en la fibrilación auricular / Discontinuation of Anticoagulation and Associated Factors in Atrial Fibrillation

RESUMEN Introducción: El objetivo del estudio fue comparar si existe diferencia en la discontinuación de los antagonistas de la vitamina K y los anticoagulantes directos y evaluar sus factores asociados en la fibrilación auricular de reciente diagnóstico. Material y métodos: Se realizó un estudio de cohortes prospectivo. El período de seguimiento fue de 12 meses. Debido a que la asignación del tratamiento no fue al azar, se realizó una ponderación por puntaje de propensión considerando las características basales potencialmente asociadas a la exposición y al resultado. Se evaluaron factores asociados a la discontinuación del anticoagulante mediante un modelo de Cox ponderado. Se incluyeron 379 pacientes con una edad media de 78 años (DE ± 9) y una prevalencia de sexo femenino del 58%. La mediana de seguimiento fue de 362 días (rango intercuartilo: 347-370 días). La pérdida de seguimiento fue del 1%. Resultados: El modelo de tiempo a la discontinuación del tratamiento anticoagulante ponderado evidenció un HR crudo de 1,40 (IC 95%: 0,79-2,48) y uno ajustado por edad, tipo de fibrilación auricular, ablación por radiofrecuencia, sangrado, cantidad de fármacos crónicos y de consultas médicas durante el seguimiento de 1,26 (IC 95%: 0,75-2,12) para el grupo tratado con anticoagulantes directos en comparación con el tratado con antagonistas de la vitamina K. Conclusiones: En nuestro medio, la discontinuación de los anticoagulantes en la fibrilación auricular no se asociaría con el tipo de fármaco empleado, la edad o el tipo de arritmia. La ablación por radiofrecuencia, la ocurrencia de sangrado y el número de consultas médicas se asociaron con la discontinuación.

ABSTRACT Background: The aim of the study was to compare if there were any differences between discontinuation of vitamin K antagonists and direct oral anticoagulants and evaluate the factors associated with such discontinuation in newly diagnosed nonvalvular atrial fibrillation. Methods: We conducted a prospective cohort study. Patients were followed-up for 12 months. Since the assignment of anticoagulation treatment was not randomized, propensity score weighting was used considering the baseline characteristics potentially associated with the exposure and result. Factors associated with the discontinuation of anticoagulant treatment were analyzed with a weighted Cox proportional hazards model. A total of 379 patients were included; mean age was 78 years (SD ± 9) and 58% were women. Median follow-up was 362 days (interquartile range: 347-370 days) and 1% was lost to follow-up. Results: The model of time to discontinuation based on inverse probability treatment weighting showed a crude HR of 1.40 (95% CI, 0.79-2.48, and of 1.26 (95% CI, 0.75-2,12, after adjustment for age, type of atrial fibrillation, radiofrequency catheter ablation, bleeding, number of chronic medications and number of medical visits during follow-up for the group treated with direct oral anticoagulants compared with the vitamin K antagonists. Conclusions: In our setting, anticoagulant discontinuation in nonvalvular atrial fibrillation would not be associated with the type of drug used, age or type of atrial fibrillation. Radiofrequency catheter ablation, bleeding events and the number of medical visits were associated with treatment discontinuation.

Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation after percutaneous coronary intervention for ST-segment elevation myocardial infarction: a post hoc analysis of the randomised RE-DUAL PCI trial.

BACKGROUND: Little is known about the optimal antithrombotic therapy in patients with atrial fibrillation undergoing PCI for ST-elevation myocardial infarction (STEMI). AIMS: The aim of this study was to investigate the safety and efficacy of dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) versus warfarin triple therapy in patients with atrial fibrillation and STEMI. METHODS: In the RE-DUAL PCI trial, 305 patients with STEMI were randomised to dabigatran 110 mg (n=113 versus 106 warfarin) or 150 mg (n=86 versus 84 warfarin). The primary endpoint was the time to first major/clinically relevant non-major bleeding event (MBE/CRNMBE). The thrombotic endpoint was a composite of death, thromboembolic events, or unplanned revascularisation. RESULTS: In STEMI patients, dabigatran 110 mg (HR 0.39, 95% CI: 0.20-0.74) and 150 mg (0.43, 0.21-0.89) dual therapy reduced the risk of MBE/CRNMBE versus warfarin triple therapy (p for interaction vs all other patients=0.31 and 0.16). The risk of thrombotic events for dabigatran 110 mg (HR 1.61, 95% CI: 0.85-3.08) and 150 mg (0.56, 0.20-1.51) had p interactions of 0.20 and 0.33, respectively. For net clinical benefit, the HRs were 0.74 (95% CI: 0.46-1.17) and 0.49 (0.27-0.91) for dabigatran 110 and 150 mg (p for interaction=0.80 and 0.12), respectively. CONCLUSIONS: After PCI for STEMI, patients on dabigatran dual therapy had lower risks of bleeding events versus warfarin triple therapy with similar risks of thromboembolic events, supporting dabigatran dual therapy even in patients with high thrombotic risk.

Aplicación sistemática de un algoritmo para el manejo lipídico en pacientes de muy alto riesgo cardiovascular. Impacto en los objetivos lipídicos / Systematic Application of an Algorithm for Lipid Management in Cardiovascular High-Risk Patients. Impact on Lipid Goals

RESUMEN Objetivo: Analizar el tratamiento hipolipemiante indicado y verificar el cumplimiento de las metas lipídicas recomendadas durante la internación y en el seguimiento precoz, luego de aplicar sistemáticamente un algoritmo para el manejo lipídico basado en las recomendaciones actuales. Material y métodos: Se incluyeron en forma consecutiva pacientes internados con síndrome coronario agudo o revascularización programada. Se aplicó sistemáticamente un algoritmo para el manejo lipídico, que incluyó: 1) indicación precoz de estatinas de alta intensidad en la internación; 2) seguimiento precoz (controles a las 6 y 12 semanas). La terapia indicada se basó en los documentos de posición de la Sociedad Argentina de Cardiología. Se analizó el cumplimiento de las metas de C-LDL (<70 mg/dl) a las 6 y 12 semanas. Resultados: Se incluyeron 292 pacientes. Se indicó estatinas (95,9% de alta intensidad) a todos los pacientes al alta hospitalaria. A las 6 semanas, el 62,5% alcanzó la meta de C-LDL. Se modificó el esquema terapéutico en el 36,3% de los sujetos (aumento de la dosis de estatinas: 19,7%; agregado de ezetimibe: 67,7%). A las 12 semanas, el 69,1% del subgrupo que no había alcanzado la meta a las 6 semanas logró el objetivo lipídico. Se indicó un inhibidor de la PCSK9 (iPCSK9) a 7 pacientes. Globalmente, el 88,4% alcanzó la meta de C-LDL a las 12 semanas. Conclusión: La aplicación sistemática de un algoritmo basado en las guías determinó que muchos sujetos de alto riesgo cardiovascular alcanzaran las metas de C-LDL a las 12 semanas. La indicación de un iPCSK9 quedó reservada para un grupo reducido de pacientes.

ABSTRACT Objective: The aim of this study was to analyze the indicated lipid-lowering therapy and verify the achievement of the recommended lipid goals during hospitalization and early follow-up, after the systematic application of a lipid management algorithm based on current recommendations. Methods: Patients hospitalized for acute coronary syndrome or programmed revascularization surgery were prospectively included in the study. A lipid management algorithm, including; 1) early indication of high-intensity statins during hospitalization and 2) early follow-up (6 and 12-week controls), was systematically applied. The therapy indicated was based on position documents of the Argentine Society of Cardiology. Achievement of LDL-C goals (<70 mg/dl) at 6 and 12 weeks was analyzed. Results: A total of 292 patients were prescribed statins (high-intensity in 95.9% of cases) at hospital discharge. AT 6 weeks, 62.5% reached the LDL-C goal. The therapeutic plan was modified in 36.3% of patients (increased dose of statins in 19.7% and addition of ezetimibe in 67.7%). At 12 weeks, 69.1% of the subgroup which has not fulfilled the goal at 6 weeks, attained the lipid target. A PCSK9 inhibitor (PCSK9i) was indicated in 7 patients. Overall, 88.4% of patients achieved the LDL-C goal at 12 weeks. Conclusion: Many cardiovascular high-risk patients reached LDL-C goals at 12 weeks with the systematic application of a guideline-based algorithm. The indication of a PCSK9i was reserved for a reduced group of patients.

Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI.

OBJECTIVES: The study sought to evaluate the effect of dabigatran dual therapy versus warfarin triple therapy across categories of renal function in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial. BACKGROUND: The RE-DUAL PCI (NCT02164864) trial of patients with atrial fibrillation undergoing percutaneous coronary intervention reported that dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) reduced the primary endpoint of major bleeding events (MBE) or clinically relevant nonmajor bleeding events (CRNMBE) compared with warfarin triple therapy, with noninferiority in overall thromboembolic events. METHODS: Risk of a first MBE or CRNMBE and the composite of death or thromboembolic event (DTE) or unplanned revascularization were evaluated in 2,725 patients according to baseline creatinine clearance (CrCl) categories: 30 to <50, 50 to <80, and ≥80 ml/min. RESULTS: Compared with warfarin, dabigatran 110 mg dual therapy reduced risk of MBE or CRNMBE across all categories of CrCl (p for interaction = 0.19). Dabigatran 150 mg dual therapy reduced risk of MBE or CRNMBE regardless of the CrCl category (p for interaction = 0.31). Risk of DTE or unplanned revascularization was similar to warfarin triple therapy for dabigatran 110 mg dual therapy across all CrCl categories. Dabigatran 150 mg dual therapy versus warfarin triple therapy had similar risk for DTE or unplanned revascularization in patients with CrCl 30 to <80 ml/min and lower risk at CrCl ≥80 ml/min (p for interaction = 0.02). CONCLUSIONS: In the RE-DUAL PCI trial, dabigatran dual therapy reduced bleeding events versus warfarin triple therapy irrespective of renal function, with overall similar risks of thromboembolic events but lower risks with dabigatran 150 mg in patients with normal CrCl.

Mortality in patients with psoriasis. A retrospective cohort study. / Mortalidad en pacientes con psoriasis. Análisis de una cohorte retrospectiva.

BACKGROUND AND OBJECTIVES: The immune and inflammatory pathways involved in psoriasis could favor the development of atherosclerosis, consequently increasing mortality. The objectives of this study were: 1) to assess the mortality of a population with psoriasis compared to a control group, and 2) to assess the prevalence of cardiovascular risk factors. PATIENTS AND METHOD: A retrospective cohort was analyzed from a secondary database (electronic medical record). All patients with a diagnosis of psoriasis at 1-01-2010 were included in the study and compared to a control group of the same health system, selected randomly (1:1). Subjects with a history of cardiovascular disease were excluded from the study. A survival analysis was performed considering death from any cause as an event. Follow-up was extended until 30-06-2015. RESULTS: We included 1,481 subjects with psoriasis and 1,500 controls. Prevalence of cardiovascular risk factors was higher in the group with psoriasis. The average follow-up time was 4.6±1.7 years. Mortality was higher in psoriasis patients compared to controls (15.1 vs. 9.6 events per 1,000 person-year, P<.005). Psoriasis was seen to be significantly associated with increased mortality rates compared to the control group in the univariate analysis (HR 1.58, 95% CI 1.16-2.15, P=.004) and after adjusting for cardiovascular risk factors (HR 1.48, 95% CI 1.08-2.3, P=.014). CONCLUSION: In this population, patients with psoriasis showed a higher prevalence for the onset of cardiovascular risk factors as well as higher mortality rates during follow-up.

[Medication adherence to secondary prevention for coronary artery disease]. / Adherencia a la prevención secundaria de la enfermedad coronaria.

We compared the use of evidence-based secondary prevention drugs for coronary artery disease at hospital discharge and 3 years of follow-up in a group of patients associated to an integrated network of health services. We conducted a retrospective group study that included 125 patients under 80 years of age who were hospitalized for acute coronary syndrome. McNemar's test was used to compare values at baseline and 3 years. The mean age of of participants was 63.7 years (SD ± 10.08) and 65.6% (95% CI 56.6-73.9) of male sex. The average follow-up time was 2.94 years (SD ± 0.25). The use of secondary prevention drugs for coronary heart disease decreased at 3 years of follow-up: anti-platelet 97.6 to 88.0% (p = 0.012), beta-blockers 94.4 to 84.8% (p = 0.021) and statins 83.7 to 91.2% (p = 0.035). Patients medicated with a combination of anti-platelet, beta blockers and statins showed a decrease from 86.4 to 66.3% (p < 0.0001). It is necessary to study the causes for the decreased adherence to long-term cardio-protective drugs.

Adherencia a la prevención secundaria de la enfermedad coronaria / Medication adherence to secondary prevention for coronary artery disease

Se comparó la adherencia a la prevención secundaria de enfermedad coronaria mediante el uso indicado de fármacos de probada eficacia, al momento del egreso hospitalario y a 3 años de seguimiento, en una cohorte de pacientes afiliados al Plan de Salud del Hospital Italiano. Se realizó un estudio de cohorte retrospectivo que incluyo 125 pacientes menores de 80 años de edad, afiliados a una red integrada de salud, con internación por síndrome coronario agudo. En el análisis se utilizó el test de McNemar. La edad media de los participantes fue 63.7 años (DS 10.08) y el 65.6% (IC95% 56.6-73.9) fue de sexo masculino. El 76.8% (IC95% 68.4-83.9) presentó como evento calificante un síndrome coronario agudo sin elevación del segmento ST. El tiempo de seguimiento promedio fue 2.94 años (DS 0.25). Se observó que el uso de drogas de probada eficacia en la prevención secundaria de enfermedad coronaria descendió entre el momento del egreso hospitalario y los 3 años de seguimiento: antiagregantes de 97.6 a 88.0% (p = 0.012); beta-bloqueantes de 94.4 a 84.8% (p = 0.021); estatinas 91.2 a 83.7% (p = 0.035). Uso combinado de antiagregantes, betabloqueantes y estatinas de 86.4 a 66.3% (p < 0.0001). Es necesario estudiar las causas de la disminución de la adherencia a drogas cardioprotectoras a largo plazo.

We compared the use of evidence-based secondary prevention drugs for coronary artery disease at hospital discharge and 3 years of follow-up in a group of patients associated to an integrated network of health services. We conducted a retrospective group study that included 125 patients under 80 years of age who were hospitalized for acute coronary syndrome. McNemar´s test was used to compare values at baseline and 3 years. The mean age of of participants was 63.7 years (SD ± 10.08) and 65.6% (95% CI 56.6-73.9) of male sex. The average follow-up time was 2.94 years (SD ± 0.25). The use of secondary prevention drugs for coronary heart disease decreased at 3 years of follow-up: anti-platelet 97.6 to 88.0% (p = 0.012), beta-blockers 94.4 to 84.8% (p = 0.021) and statins 83.7 to 91.2% (p = 0.035). Patients medicated with a combination of anti-platelet, beta blockers and statins showed a decrease from 86.4 to 66.3% (p < 0.0001). It is necessary to study the causes for the decreased adherence to long-term cardio-protective drugs.

Recuento de glóbulos blancos como predictor de hallazgos angiográficos y eventos clínicos en los síndromes coronarios agudos sin supradesnivel del segmento ST.: Subanálisis del estudio PACS angiográfico / Leukocyte Count as Predictor of Angiographic Findings and Clinical Events in Non-ST-Segment Elevation Acute Coronary Syndromes.: Sub-analysis of the PACS Angiographic Study

Introducción La relación entre los marcadores inflamatorios y los síndromes coronarios agudos se ha estudiado previamente. PACS (Prognosis in Acute Coronary Syndromes) fue un estudio prospectivo multicéntrico que se desarrolló entre enero de 2000 y mayo de 2002 en 11 unidades coronarias de la Argentina e incluyó pacientes con síndrome coronario agudo sin elevación del segmento ST (SCASEST) con el objetivo de determinar el valor pronóstico de los diferentes biomarcadores, solos o en combinación en la estratificación de riesgo. Sin embargo, la relación de la elevación de leucocitos con los hallazgos angiográficos y los eventos a mediano plazo se ha estudiado escasamente. Objetivo Determinar si el nivel de leucocitos al ingreso se relaciona con lesiones coronarias complejas y pronóstico adverso a los 6 meses en pacientes internados con SCASEST. Material y métodos El subestudio PACS angiográfico comprendió un subgrupo de 1.253 pacientes de la cohorte del estudio PACS central (cuya población total fue de 1.500 pacientes) e incluyó centros con disponibilidad de cinecoronariografía (CCG). De los 1.253 pacientes del subestudio, se realizó una CCG (media de tiempo 48 horas del ingreso, percentiles 25-75, 24-72 horas) en 633 (50,5%). Para el presente subanálisis se obtuvieron datos completos de 580 pacientes (46,2%). En estos, además de lo establecido en el protocolo PACS de biomarcadores, se analizó el recuento de leucocitos en sangre dentro de las 24 horas de la admisión. La población se dividió en percentiles según el recuento leucocitario al ingreso. En el percentil inferior se incluyeron los pacientes con un recuento inicial de glóbulos blancos < 7.700/mm³, en el percentil intermedio los pacientes con un recuento de entre 7.700 y 11.500/mm³ y en el percentil superior aquellos con > 11.500/mm³. Resultados De los 580 pacientes, la mayoría eran hombres (72,9%), edad media de 66 años (± 12). Tenían antecedentes de hipertensión el 64,4%, de diabetes el 17,9%, historia de infarto previo el 22,2%, riesgo clínico alto (ACC/AHA) el 60% y el electrocardiograma de ingreso mostró alteración del segmento ST o T en el 61,1%. El recuento de leucocitos superior a 11.500/mm³ se asoció con una tasa mayor de trombo visible, presencia de placa complicada y mayor extensión de enfermedad coronaria (p = 0,019, 0,033 y 0,07, respectivamente). En el seguimiento a 6 meses, los pacientes del percentil superior tuvieron mayor tendencia a muerte o infarto que los pacientes del percentil inferior (14,2% vs. 7,5%; p = 0,026). Conclusión En los pacientes con SCASEST, un recuento elevado de leucocitos al ingreso se asocia con lesiones coronarias complejas y peor pronóstico a los 6 meses.

Background Previous studies have analyzed the relationship between inflammatory markers and acute coronary syndromes. Prognosis in Acute Coronary Syndromes (PACS) is a prospective, multicentric study conducted between January 2000 and May 2002 in 11 coronary care units of Argentina. It determined the prognostic value of different biomarkers, alone or in combination, to stratify risk in patients with non-ST-segment elevation acute coronary syndromes (NSTEACS). However, there are few studies on the relationship of increased leuko-cyte levels with angiographic findings and mid-term events. Objective The aim of the study was to establish whether leukocyte count at admission is associated with complex coronary disease and adverse prognosis at 6-month follow-up in patients with NSTEACS. Methods The angiographic PACS substudy was conducted in 1253 patients from the PACS study core group (with a population of 1500 patients) and it included centers with coronary angiography (CA). Out of the 1253 substudy patients, CA was performed in 633 (50.5%) (mean of 48 hours after admission, percentiles 25-75, 24-72 hours). To perform the sub-analysis, complete data were obtained from 580 patients (46.2%). In this group, leukocyte count within 24 hours of admission was analyzed in addition to tests performed in the biomarkers PACS protocol. The population was divided in percentiles according to admission leukocyte count. Patients with initial leukocytes < 7700/ mm³ were included in the lower percentile, patients with leukocyte count between 7700 and 11500/mm³ in the middle percentile and those with leukocyte count > 11500/mm³ in the higher percentile. Results Most of the 580 patients were men (72.9%), and mean age was 66±12 years. Among these patients, 64.4% had history of hypertension, 17.9% of diabetes, 22.2% of previous infarction, 60% presented high clinical risk (ACC/AHA) and 61.1% had ECG at admission with ST-segment or T wave alterations. Leukocyte count > 11500/mm³ was associated with higher rate of visible thrombus, presence of complicated plaque and more extensive coronary disease (p = 0.019, 0.033 and 0.07, respectively). At the 6-month follow-up, patients in the higher percentile had greater tendency of death or infarction than patients in the lower percentile (14.2% vs. 7.5%; p = 0.026). Conclusion In patients with NSTEACS, a high leukocyte count at admission is associated with complex coronary disease and worse prognosis at 6 month-follow-up.

Anticoagulation with otamixaban and ischemic events in non-ST-segment elevation acute coronary syndromes: the TAO randomized clinical trial.

IMPORTANCE: The optimal anticoagulant for patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) managed with an invasive strategy remains controversial. OBJECTIVE: To compare the clinical efficacy and safety of otamixaban, a novel intravenous direct factor Xa inhibitor, with that of unfractionated heparin plus downstream eptifibatide in patients with NSTE-ACS undergoing a planned early invasive strategy. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, active-controlled superiority trial that enrolled 13,229 patients with NSTE-ACS and a planned early invasive strategy, at 568 active sites in 55 countries and conducted between April 2010 and February 2013. A planned interim analysis was conducted for otamixaban dose selection. INTERVENTIONS: Eligible participants were randomized to otamixaban (bolus and infusion, at 1 of 2 doses) or unfractionated heparin plus, at the time of percutaneous coronary intervention, eptifibatide. The otamixaban dose selected at interim analysis was an intravenous bolus of 0.080 mg/kg followed by an infusion of 0.140 mg/kg per hour. MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was the composite of all-cause death or new myocardial infarction through day 7. RESULTS: Rates of the primary efficacy outcome were 5.5% (279 of 5105 patients) randomized to receive otamixaban and 5.7% (310 of 5466 patients) randomized to receive unfractionated heparin plus eptifibatide (adjusted relative risk, 0.99 [95% CI, 0.85-1.16]; P = .93). There were no differences for the secondary end points, including procedural thrombotic complications. The primary safety outcome of Thrombosis in Myocardial Infarction major or minor bleeding through day 7 was increased by otamixaban (3.1% vs 1.5%; relative risk, 2.13 [95% CI, 1.63-2.78]; P < .001). Results were consistent across prespecified subgroups. CONCLUSIONS AND RELEVANCE: Otamixaban did not reduce the rate of ischemic events relative to unfractionated heparin plus eptifibatide but did increase bleeding. These findings do not support the use of otamixaban for patients with NSTE-ACS undergoing planned early percutaneous coronary intervention. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01076764.