[Absence of benefit with triple antiaggregation in acute non persistent ST segment elevation myocardial infarction in patients not subjected to early interventionism]. / Ausencia de beneficio con triple antiagregación en el síndrome coronario agudo sin elevación persistente del segmento ST, en pacientes no sometidos a intervencionismo precoz.

OBJECTIVE: To assess the efficacy and safety of a treatment with clopidogrel when associated or not to the treatment with tirofiban and aspirin for high-risk non-ST segment elevation myocardial infarction (non-STEMI), without early angioplasty. SETTING: Intensive Care and Coronary Unit (ICCU), in a center with no Hemodynamic Laboratory. DESIGN: Non randomized clinical trial. PARTICIPANTS: One hundred and twenty-three patients admitted with the diagnosis of high-risk non-STEMI, defined as patients with chest pain and one of the following: ST segment depression or transient elevation or an elevation in cardiac troponin I (TropIc). INTERVENTIONS: We included patients admitted in a 24-month period. During the first 12-month period, the patients received tirofiban and clopidogrel (group A). In the second one, clopidogrel was not administered (group B). Urgent cardiac catheterism was requested if recurrent ischemic chest pain with ST segment changes, left ventricular failure or hemodynamic instability were present. PRIMARY VARIABLES: A composite of recurrent ischemic chest pain with ST segment changes or death during ICCU admission was evaluated as an efficacy variable. A variable of safety was defined as the occurrence of intracranial or gastrointestinal bleeding, or any hemorrhagic event accompanied by a drop of at least 3 g/dl of hemoglobin. The rate of urgent cardiac catheterisms was recorded. RESULTS: Neither the rate of the efficacy variable (19.6 % in group A and 19.4% in group B; p = 0.97), nor the rate of the safety variable (3.5% and 2.9% of patients in groups A and B, p = 1) showed statistically significant difference. There was no statistically significant difference in the rate of urgent cardiac catheterism (19.6% in group A and 13.4% in group B; p = 0.35). CONCLUSIONS: In the early course of high-risk non-STEMI with a conservative management strategy, the addition of clopidogrel to tirofiban does not change the rate of ischemic events, death, need of urgent catheterism or hemorrhagic events.

Ausencia de beneficio con triple antiagregación en el síndrome coronario agudo sin elevación persistente del segmento ST, en pacientes no sometidos a intervencionismo precoz / Absence of benefit with tripleantiaggregation in acute non persistent ST segment elevation myocardial infarction in patients not subjected to early interventionism

Objetivo. Valorar la eficacia y seguridad del tratamiento con clopidogrel cuando se asocia o no al tratamiento con tirofibán más ácido acetilsalicílico (AAS) en el síndrome coronario agudo sin elevación persistente del segmento ST (SCASEST) de alto riesgo, sin intervencionismo precoz. Ámbito. Unidad de Cuidados Intensivos (UCI), en centro sin laboratorio de hemodinámica. Diseño. Ensayo clínico sin asignación aleatoria. Pacientes. Ciento veintitrés pacientes con SCASEST de alto riesgo, definido como dolor torácico y uno de los siguientes: descenso del segmento ST o ascenso transitorio o aumento de troponina I cardíaca (TropIc). Intervenciones. Estudio desarrollado durante veinticuatro meses. Los primeros doce meses el tratamiento incluía tirofibán y clopidogrel (grupo A); en los siguientes doce meses, el clopidogrel no se administraba (grupo B). El cateterismo cardíaco urgente se solicitó si aparecía dolor torácico recurrente con cambios en el segmento ST, fallo ventricular izquierdo o inestabilidad hemodinámica. Variables principales. Se evaluó una variable de eficacia, formada por la combinación de la aparición de dolor torácico con cambios en el segmento ST o muerte durante la estancia en la UCI, y una variable de seguridad, definida por la existencia de hemorragias intracraneales, digestivas o aquellas asociadas a una disminución de hemoglobina de al menos 3 g/dl. Se registró la frecuencia de realización de cateterismo urgente. Resultados. No hubo diferencias estadísticas significativas en la frecuencia de la variable de eficacia (19,6% en el grupo A y 19,4% en el grupo B; p = 0,97), ni en la de seguridad (3,5 y 2,9% en los grupos A y B respectivamente; p = 1). Tampoco existió diferencia estadística significativa en la realización de cateterismo urgente (19,6% en el grupo A y 13,4% en el grupo B; p = 0,35). Conclusiones. En el curso inicial del SCASEST de alto riesgo con una estrategia de tratamiento conservadora, la adición de clopidogrel al tirofibán no modifica la aparición de eventos isquémicos, muerte o necesidad de cateterismo urgente, ni se asocia a un incremento de complicaciones hemorrágicas

Objective. To assess the efficacy and safety of a treatment with clopidogrel when associated or not to the treatment with tirofiban and aspirin for high-risk non-ST segment elevation myocardial infarction (non-STEMI), without early angioplasty. Setting. Intensive Care and Coronary Unit (ICCU), in a center with no Hemodynamic Laboratory. Design. Non randomized clinical trial. Participants. One hundred and twenty-three patients admitted with the diagnosis of high-risk non-STEMI, defined as patients with chest pain and one of the following: ST segment depression or transient elevation or an elevation in cardiac troponin I (TropIc). Interventions. We included patients admitted in a 24-month period. During the first 12-month period, the patients received tirofiban and clopidogrel (group A). In the second one, clopidogrel was not administered (group B). Urgent cardiac catheterism was requested if recurrent ischemic chest pain with ST segment changes, left ventricular failure or hemodynamic instability were present. Primary variables. A composite of recurrent ischemic chest pain with ST segment changes or death during ICCU admission was evaluated as an efficacy variable. A variable of safety was defined as the occurrence of intracranial or gastrointestinal bleeding, or any hemorrhagic event accompanied by a drop of at least 3 g/dl of hemoglobin. The rate of urgent cardiac catheterisms was recorded. Results. Neither the rate of the efficacy variable (19.6 % in group A and 19.4% in group B; p = 0.97), nor the rate of the safety variable (3.5% and 2.9% of patients in groups A and B, p = 1) showed statistically significant difference. There was no statistically significant difference in the rate of urgent cardiac catheterism (19.6% in group A and 13.4% in group B; p = 0.35). Conclusions. In the early course of high-risk non-STEMI with a conservative management strategy, the addition of clopidogrel to tirofiban does not change the rate of ischemic events, death, need of urgent catheterism or hemorrhagic events

[Sedoanalgesia with remifentanil in definitive pacemaker implant]. / Sedoanalgesia con remifentanilo en el implante de marcapasos definitivo.

OBJECTIVE: Describe the use of remifentanil in definitive pacemaker implant. DESIGN: Prospective, observational study. SCOPE: Intensive Care Unit of two general hospitals. PATIENTS: Ninety-four patients subjected to DPM implant under sedation with remifentanil. INTERVENTIONS: The protocol for DPM implant was conducted: premedication with metoclopramide, remifentanil perfusion (20 micro g/ml), local infiltration with mepivacaine 2%, administration of magnesium metamizole at the end of the implant and posterior discontinuation of remifentanil. Remifentanil perfusion was initiated at 2 micro g/minute, increasing it until reaching a sedation grade 2-3 on the Ramsay scale, with a maximum of 6 micro g/minute. MAIN ENDPOINTS: Time needed to reach the desired sedation grade and duration of sedation, maximum dose of remifentanil necessary, frequency that another sedation was needed and of adverse events were recorded. Continuous quantitative endpoints were expressed as mean +/- SD. RESULTS: A sedation grade 2-3 was achieved with a perfusion rhythm of 3.6 +/- 1.4 micro g/min, in 20 +/- 22 minutes. In 89 patients (94.6%), the implant was performed only with remifentanil. Frequency of adverse events were nauseas/vomiting 21.3%, hypotension 5.3% and respiratory depression 1%. Remifentanil perfusion was discontinued in 3 patients (3.2%) due to appearance of adverse events. Another sedoanalgesic was used in 2 patients (2.1%). CONCLUSIONS: Remifentanil is useful in the implant of DPM as a sedoanalgesia method. Serious undesired effects are rare. Future studies are necessary to completely establish its effectiveness and safety in these types of procedures.

Sedoanalgesia con remifentanilo en el implante de marcapasos definitivo / Sedoanalgesia with remifentanilin definitive pacemaker implant

Objetivo. Describir el empleo de remifentanilo en el implante de marcapasos definitivo. Diseño. Estudio prospectivo observacional. Ámbito. Unidad de Cuidados Intensivos de dos hospitales generales. Pacientes. Noventa y cuatro pacientes sometidos a implante de marcapasos definitivo (MPD) bajo sedación con remifentanilo. Intervenciones. Se llevó a cabo el protocolo para implantación de MPD: premedicación con metoclopramida, perfusión de remifentanilo (20 µg/ml), infiltración local con mepivacaína 2%, administración de metamizol magnésico al terminar el implante y suspensión posterior de remifentanilo. La perfusión de remifentanilo se inició con 2 µg/minuto, incrementándola hasta alcanzar un grado de sedación 2-3 en la escala de Ramsay, con un máximo de 6 µg/minuto. Variables principales. Se registraron los tiempos transcurridos en alcanzar el grado de sedación deseado y de permanencia de la sedación, la dosis máxima necesaria de remifentanilo, la frecuencia con la que se necesitó otra sedación y la de efectos adversos. Las variables cuantitativas continuas se expresaron como media ± desviación estándar (DE). Resultados. Un grado de sedación 2-3 se consiguió con un ritmo de perfusión de 3,6 ± 1,4 µg/minuto, en 20 ± 22 minutos. En 89 pacientes (94,6%) el implante se llevó a cabo con remifentanilo exclusivamente. La frecuencia de efectos adversos fueron náuseas/vómitos 21,3%, hipotensión 5,3% y depresión respiratoria 1%. La perfusión de remifentanilo fue suspendida en 3 pacientes (3,2%) por la aparición de efectos adversos. Se empleó otra sedoanalgesia en 2 pacientes (2,1%). Conclusiones. El remifentanilo es útil en el implante de MPD como método de sedoanalgesia. Los efectos indeseables graves son poco frecuentes. Son necesarios futuros estudios para establecer completamente su efectividad y seguridad en este tipo de procedimientos

Objective. Describe the use of remifentanil in definitive pacemaker implant. Design. Prospective, observational study. Scope. Intensive Care Unit of two general hospitals. Patients. Ninety-four patients subjected to DPM implant under sedation with remifentanil. Interventions. The protocol for DPM implant was conducted: premedication with metoclopramide, remifentanil perfusion (20 µg/ml), local infiltration with mepivacaine 2%, administration of magnesium metamizole at the end of the implant and posterior discontinuation of remifentanil. Remifentanil perfusion was initiated at 2 µg/minute, increasing it until reaching a sedation grade 2-3 on the Ramsay scale, with a maximum of 6 µg/minute. Main endpoints. Time needed to reach the desired sedation grade and duration of sedation, maximum dose of remifentanil necessary, frequency that another sedation was needed and of adverse events were recorded. Continuous quantitative endpoints were expressed as mean ± SD. Results. A sedation grade 2-3 was achieved with a perfusion rhythm of 3.6 ± 1.4 µg/min, in 20 ± 22 minutes. In 89 patients (94.6%), the implant was performed only with remifentanil. Frequency of adverse events were nauseas/vomiting 21.3%, hypotension 5.3% and respiratory depression 1%. Remifentanil perfusion was discontinued in 3 patients (3.2%) due to appearance of adverse events. Another sedoanalgesic was used in 2 patients (2.1%). Conclusions. Remifentanil is useful in the implant of DPM as a sedoanalgesia method. Serious undesired effects are rare. Future studies are necessary to completely establish its effectiveness and safety in these types of procedures