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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.
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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.
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Síndrome Coronariana Aguda/tratamento farmacológico , Anticoagulantes/uso terapêutico , Óxidos N-Cíclicos/uso terapêutico , Inibidores do Fator Xa , Hemorragia/induzido quimicamente , Heparina/uso terapêutico , Peptídeos/uso terapêutico , Piridinas/uso terapêutico , Síndrome Coronariana Aguda/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Causas de Morte , Óxidos N-Cíclicos/efeitos adversos , Método Duplo-Cego , Eptifibatida , Feminino , Humanos , Infusões Intravenosas , Injeções Intravenosas , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Piridinas/efeitos adversos , Risco , Análise de Sobrevida , Resultado do TratamentoRESUMO
BACKGROUND: In the present study, we aimed to analyze the diagnostic and prognostic potential of a newly developed high-sensitive troponin T assay and compared these results with those of a contemporary troponin T assay in 2 distinct patient cohorts, one including patients with evident ACS and the other one including patients with general chest pain. METHODS AND RESULTS: For this study, we analyzed data from 2 independent patient cohorts, the Bad Nauheim ACS registry and the Prognosis in Acute Coronary Syndromes registry, with a total of 2,506 patients. On admission, clinical data have been recorded, and a single measurement of troponin T has been performed with a contemporary assay (TnT) and a new high-sensitive troponin T assay (hsTnT). Clinical follow-up has been obtained after 6 months. The diagnostic value of hsTnT was superior to TnT (area under the receiver operating characteristic curve 0.949 vs 0.929, P = .016). Specifically, in TnT-negative patients, hsTnT provided strong diagnostic information (area under the receiver operating characteristic curve of 0.81, P < .001). Furthermore, hsTnT provided independent prognostic power for mortality within 6 months in both cohorts, which was superior to that of the contemporary TnT assay. CONCLUSION: Troponin T measured with a newly developed hsTnT provides better diagnostic and prognostic information and, therefore, should be implemented as a standard test in clinical routine.
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Síndrome Coronariana Aguda/diagnóstico , Biomarcadores/sangue , Troponina T/sangue , Síndrome Coronariana Aguda/sangue , Idoso , Diagnóstico Diferencial , Feminino , Seguimentos , Humanos , Imunoensaio , Masculino , Pessoa de Meia-Idade , Prognóstico , Curva ROC , Sistema de Registros , Estudos Retrospectivos , Índice de Gravidade de DoençaRESUMO
UNLABELLED: NT-probrain natriuretic peptide (NT-proBNP) has been associated with left ventricular (LV) dysfunction and adverse outcome in patients with non-ST-elevation acute coronary syndromes (NSTEACS). However, the underlying pathophysiological mechanisms responsible for this association have not been well established. We sought to explore the relation between NT-proBNP levels and extension of coronary artery disease (CAD) and the presence of more complex and severe coronary lesions. METHODS: This prospective, multicenter angiographic substudy included 585 patients admitted with NSTEACS. Blinded measurements of NT-proBNP and troponin T were performed at a median time of 3 hours after admission and analyzed centrally. Angiograms were read at a core laboratory by 2 independent readers blinded to patient data. Complex coronary lesion was defined as the presence of at least one of the following: thrombus (+), TIMI flow < 2, or ulcerated plaque. RESULTS: NT-probrain natriuretic peptide levels increased proportionally as LV function decreased. The levels of NT-proBNP were directly related to the extent of the CAD. This association was maintained when we analyzed patients with normal LV function (n = 257). Patients with complex coronary lesions or those with at least one of its individual component had higher levels of NT-proBNP compared with those without complex coronary lesions. After adjusting for clinical and electrocardiographic variables and other biomarkers, positive troponin (OR 2.20, 95% CI 1.50-3.22, P < .0001) and supramedian NT-proBNP levels (OR 1.72, 95% CI 1.19-2.47, P = .003) independently contributed to the prediction of complex coronary lesions. CONCLUSION: In this study of patients with NSTEACS, NT-proBNP levels progressively increase with the severity of CAD and degree of LV dysfunction. Increased levels of NT-proBNP independently predict the presence of more complex coronary lesions.
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Angiografia Coronária , Doença das Coronárias/diagnóstico por imagem , Doença das Coronárias/fisiopatologia , Peptídeo Natriurético Encefálico/sangue , Fragmentos de Peptídeos/sangue , Doença Aguda , Idoso , Doença das Coronárias/complicações , Feminino , Humanos , Masculino , Estudos Multicêntricos como Assunto , Valor Preditivo dos Testes , Prognóstico , Estudos Prospectivos , Índice de Gravidade de Doença , Síndrome , Disfunção Ventricular Esquerda/etiologia , Disfunção Ventricular Esquerda/fisiopatologiaRESUMO
Introducción y objetivos: Los hallazgos clínicos, electrocardiográficos y los niveles séricos de CK-MB son variables pronósticas en la evaluación de pacientes con dolor precordial. El objetivo de este trabajo fue determinar el valor pronóstico adicional de la troponina I (TnI) y de la proteína C reactiva (PCR) en una población de pacientes con dolor de precordial que consultan al Departamento de Emergencias. Material y métodos: Se realizó el seguimiento de 784 pacientes consecutivos con dolor precordial durante 120 días para evaluar la frecuencia de muerte o IM no fatal. Se obtuvo sangre al ingreso para evaluar los niveles de TnI y PCR. Los investigadores fueron ciegos a estos resultados. Resultados: Del total de pacientes, 394 (50,2 por ciento) fueron dados de alta (dolor no coronario) y 390 (49,8 por ciento) fueron hospitalizados con diagnóstico de angina inestable o infarto. La frecuencia de muerte o infarto a los 120 días fue del 3,8 por ciento; la frecuencia más alta (14,9 por ciento) se observó en el grupo con TnI y PCR elevadas (p = 0,0001). Se identificaron cuatro predictores independientes de muerte o infarto por regresión de Cox: enfermedad coronaria previa (HR 2,97, IC 95 por ciento 1,42- 6,25; p = 0,004); cambios del segmento ST (HR 3,01, IC 95 por ciento 1,31-7,14; p = 0,009); TnI = 0,4 ng/ml (HR 2,85, IC 95 por ciento 1,23-6,66; p = 0,015) y PCR = 5 mg/L (HR 2,42, IC 95 por ciento 1,45-5,26; p = 0,020). La combinación de TnI y PCR fue superior que la estratificación convencional por clínica y ECG, especialmente en el grupo de riesgo intermedio. Conclusiones: En pacientes con dolor torácico, la combinación de TnI y PCR mejora la estratificación de riesgo en comparación con el uso convencional de la clínica y el ECG, especialmente en los pacientes con un nivel de riesgo intermedio.
