Prevalence of pharmacological adherence in patients with coronary artery disease and associated factors / Prevalência da adesão farmacológica de pacientes com doença arterial coronariana e fatores associados / Prevalencia de la adhesión farmacológica de pacientes con enfermedad arterial coronaria y factores asociados

Objective: to assess the prevalence of pharmacological adherence in patients with coronary artery disease and to identify factors associated with adherence. Method: a crosssectional, correlational study, including 198 patients with a previous diagnosis of coronary artery disease. Pharmacological adherence was assessed by the four-item Morisky Green test, and the factors that potentially interfere with adherence were considered independent variables. The association between the variables was determined by the Cox model, with a 5% significance level. Results: 43% of the patients adhered to the treatment. Fatigue and palpitation, never having consumed alcohol and being served by medical insurance were associated with adherence. Lack of adherence was associated with considering the treatment complex, consumption of alcohol and being served by the public health care system. In the multiple analysis, the patients with fatigue and palpitations had a prevalence of adherence around three times higher and alcohol consumption was associated with a 2.88 times greater chance of non-adherence. Conclusion: more than half of the patients were classified as non-adherent. Interventions can be directed to some factors associated with lack of adherence.

Objetivo: avaliar a prevalência da adesão farmacológica de pacientes com doença arterial coronariana e identificar os fatores associados à adesão. Método: estudo transversal, correlacional, incluindo 198 pacientes com diagnóstico prévio de doença arterial coronariana. A adesão farmacológica foi avaliada pelo teste de Morisky Green de quatro itens e os fatores que potencialmente interferem na adesão foram considerados variáveis independentes. A associação entre as variáveis foi verificada pelo modelo de Cox, com nível de significância de 5%. Resultados: 43% dos pacientes aderiram ao tratamento. Associaram-se à adesão os sintomas de fadiga e palpitação, nunca ter ingerido bebida alcoólica e ser atendido por convênio médico. Associaram-se à falta de adesão considerar o tratamento complexo, o consumo de bebidas alcoólicas e ser atendido pelo sistema público de saúde. Na análise múltipla, os pacientes que apresentavam fadiga e palpitação tiveram prevalência de adesão em torno de três vezes maior e o consumo de álcool associou-se a uma chance 2,88 vezes maior de não adesão. Conclusão: mais da metade dos pacientes foram classificados como não aderentes. Intervenções podem ser direcionadas para alguns fatores associados à falta de adesão.

Objetivo: evaluar la prevalencia de la adhesión farmacológica de pacientes con enfermedad arterial coronaria e identificar los factores asociados a la adhesión. Método: estudio transversal, correlacional, que incluyó a 198 pacientes con diagnóstico previo de enfermedad arterial coronaria. Se evaluó la adhesión farmacológica mediante la prueba de Morisky Green de cuatro ítems y se consideró como variables independientes los factores que potencialmente interfieren en la adhesión. La asociación entre las variables se verificó con el modelo de regresión de Cox, con nivel de significancia del 5%. Resultados: el 43% de los pacientes adherían al tratamiento. Se asociaron a la adhesión los síntomas de fatiga y palpitaciones, nunca haber ingerido bebida alcohólica y recibir tratamiento de medicina prepaga. Se asoció a la falta de adhesión considerar complejo el tratamiento, consumir bebidas alcohólicas y recibir tratamiento del sistema público de salud. En el análisis múltiple, los pacientes que presentaban fatiga y palpitaciones tuvieron cerca de tres veces más prevalencia de adhesión y el consumo de alcohol se asoció a una posibilidad 2,88 veces mayor de no adhesión. Conclusión: se clasificó a más de la mitad de los pacientes como no adherentes. Es posible direccionar acciones hacia algunos factores asociados a la falta de adhesión.

Medication regimen complexity of coronary artery disease patients / Complexidade da farmacoterapia de pacientes com doença arterial coronariana

ABSTRACT Objective: To determine the factors associated with the high complexity of medication regimen in patients with coronary artery disease. Methods: A cross-sectional study was carried out in a multiprofessional cardiology outpatient clinic, in the Secondary Care of the Unified Health System, where sociodemographic (age, sex, and education), clinical (number of health conditions, cardiovascular diagnoses, and comorbidities) and pharmacotherapeutic (adherence, polypharmacy, and cardiovascular polypharmacy) characteristics were collected. These were related to complexity of medication regimen, measured through the medication regimen complexity index. The classification of high complexity of medication regimen was carried out using standardization for the older adults and stratification for adult patients, as suggested in the literature. Results: The total complexity medication regimen of 148 patients had a median of 17.0 (interquartile range of 10.5). In the univariate analysis, the factors associated with high complexity were heart failure, diabetes mellitus, hypertension, five or more diseases, and non-adherence to treatment. In the final model, after logistic regression, there was a statistically significant association (p<0.05) with the variables diabetes mellitus, hypertension, and non-adherence. Conclusion: The high complexity of medication regimen in patients with coronary artery disease was associated with the presence of diabetes mellitus, hypertension, and reports of non-adherence to treatment.

RESUMO Objetivo: Determinar os fatores associados à complexidade alta da farmacoterapia em pacientes com doença arterial coronariana. Métodos: Realizou-se um estudo transversal em um ambulatório multiprofissional de cardiologia na Atenção Secundária do Sistema Único de Saúde, de onde foram coletadas características sociodemográficas (idade, sexo e escolaridade), clínicas (número de condições de saúde, diagnósticos cardiovasculares e comorbidades) e farmacoterápicas (adesão, polifarmácia e polifarmácia cardiovascular). Essas características foram relacionadas com a complexidade da farmacoterapia, mensurada por meio do Índice de Complexidade da Farmacoterapia. A classificação em complexidade alta da farmacoterapia foi realizada empregando a normatização para idosos e a estratificação para pacientes adultos, sugeridas na literatura. Resultados: A complexidade da farmacoterapia total dos 148 pacientes apresentou mediana igual a 17,0 (amplitude interquartílica de 10,5). Na análise univariada, os fatores associados à complexidade alta foram insuficiência cardíaca, diabetes mellitus, hipertensão arterial, cinco ou mais doenças e não adesão. No modelo final, após regressão logística, houve associação estatisticamente significante (p<0,05) com as variáveis diabetes mellitus, hipertensão arterial e não adesão. Conclusão: A complexidade alta da farmacoterapia em pacientes com doença arterial coronariana foi associada à presença de diabetes mellitus, hipertensão arterial e relato de não adesão a medicamentos

Key data elements for clinical management and outcomes of patients with coronary artery disease: definitions from Coronary Artery Disease and Creative Antithrombotic Clinical Research Collaboration (CardiaCare) / 中华心血管病杂志

Objective: To develop a set of data elements and standardized definitions of Coronary Artery Disease and Creative Antithrombotic Clinical Research Collaboration (CardiaCare), aiming to facilitate the exchange of disparate data sources, enhance the abilities to support multicenter researches, and subsequently ensure the databases use under standardized process and criteria. Methods: The Cardiacare writing committee members reviewed data elements and definitions from published guidelines, clinical trials, databases, and standardized documents, then determined the data elements and standardized definitions, which should be included in CardiaCare. The writing committee also considered the specific domestic clinical management strategies during the establishment of Cardiacare. The resulting documents provide a series of key data elements and standardized definitions used in the management of coronary artery disease patients. Key data elements from CardiaCare could be sorted by clinical management flowsheet and outcome from hospitalization to long-term follow-up. Results: The Cardiacare standardized set comprised 864 data elements from admission to post-hospital follow-up visit. There were 8 tables in the documents, including demographic and admission information (23 elements), medical history and risk factors (102 elements), clinical presentations and diagnosis (22 elements), diagnostic and laboratory tests (111 elements), interventional diagnosis and treatment (118 elements), pharmacological therapy (213 elements), clinical outcomes (161 elements), and special subpopulations (114 elements: 87 elements for transcatheter valve replacement and 27 elements with cardiac rehabilitation). Conclusions: The Cardiacare standardized data elements set could provide support for real-world clinical research in consecutive data collection and databases mining. A wider applicability in various settings of CardiaCare needs to be explored further.

Efficacy and safety of Shexiang Baoxin pill (MUSKARDIA) in patients with stable coronary artery disease: a multicenter, double-blind, placebo-controlled phase IV randomized clinical trial / 中华医学杂志(英文版)

BACKGROUND@#The Shexiang Baoxin Pill (MUSKARDIA) has been used for treating coronary artery disease (CAD) and angina for more than 30 years in China. Nevertheless, methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce. The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy (OMT) in patients with stable CAD.@*METHODS@#A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months. Both groups received OMT according to local tertiary hospital protocols. The primary outcome was the occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. Secondary outcomes included all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency.@*RESULTS@#In all, 99.7% of the patients were treated with aspirin and 93.0% with statin. After 2 years of treatment, the occurrence of MACEs was reduced by 26.9% in the MUSKARDIA group (MUSKARDIA: 1.9% vs. placebo: 2.6%; odds ratio = 0.80; 95% confidence interval: 0.45-1.07; P  = 0.2869). Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362). Other secondary endpoints were similar between the two groups. The rates of adverse events were also similar between the two groups (MUSKARDIA: 17.7% vs. placebo: 17.4%, P = 0.8785).@*CONCLUSIONS@#As an add-on to OMT, MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD. Moreover, the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD. The results suggest that MUSKARDIA can be used to manage patients with CAD.@*TRIAL REGISTRATION@#chictr.org.cn, No. ChiCTR-TRC-12003513.

Comunicación breve: aspirina en la prevención primaria de la enfermedad ateroesclerótica cardiovascular y su automedicación: Un problema por solucionar / Brief communication: aspirin in primary prevention of cardiovascular atherosclerotic disease and its self-medication A problem to solve

Millones de personas, sin indicación médica, toman aspirina para la prevención primaria de la enfermedad ateroesclerótica cardiovascular. La Sociedad Europea de Cardiología no la recomienda para prevención primaria de esta entidad y las Guías del ACC/ AHA sobre Prevención Primaria de la Enfermedad Ateroesclerótica Cardiovascular la recomiendan solo en personas con riesgo cardiovascular aumentado. El beneficio de la aspirina en pacientes con enfermedad cardiovascular establecida sobrepasa el riesgo de sangrado. Ese beneficio se debe al efecto antiinflamatorio y anti-plaquetario, que reduce el riesgo de aterotrombosis, pero con riesgo de sangrado particularmente en individuos susceptibles de sangrar. El papel de esta medicación en individuos sin enfermedad cardiovascular establecida es controversial en especial si tienen riesgo de sangrado. En esta comunicación se discuten las En las Guías del ACC/AHA, el estudio ASCEND en diabéticos, el ASPREE en ancianos sanos y el ARRIVE en pacientes con moderado a alto riesgo y otros para que sirva de alarma a los médicos generales y especialistas, a fin de que indaguen sobre el uso de aspirina en sus pacientes, y al mismo tiempo discutan sobre el balance entre el daño y los beneficios, particularmente en los pacientes ancianos y en aquellos con riesgo de sangrado. Se sugiere realizar un estudio para obtener la evidencia del número de personas que ingieren aspirina automedicada, realizar su seguimiento, y evolución una vez conocidas ampliamente e implementadas las presentes recomendaciones(AU)

Millions of people, without medical indication, take aspirin for the primary prevention of cardiovascular atherosclerotic disease. The European Society of Cardiology does not recommend it for primary prevention, and the ACC/AHA Guidelines on Primary Prevention of Cardiovascular Atherosclerotic Disease recommend it only in people with increased cardiovascular risk. The benefit of aspirin in patients with established cardiovascular disease outweighs the risk of bleeding. This benefit is due to the anti-inflammatory and anti-platelet effect, which reduces the risk of atherothrombosis, but with the risk of bleeding, particularly in individuals susceptible to bleeding. However, the role of this medication as primary prevention in individuals without established cardiovascular disease is controversial especially if they are at risk of bleeding. Despite the recommendations of the ACC/AHA and the European guidelines aspirin continues to be auto medicated for a large number of subjects. In this communication we discuss the ACC / AHA Guidelines, the ASCEND study in diabetics, the ASPREE in healthy elderly and the ARRIVE in patients with moderate to high risk and others to serve as an alarm to general practitioners and specialists, in order for them to inquire about the use of aspirin in their patients, and at the same time discuss the balance between the harm and the benefits, particularly in elderly patients and those at risk of bleeding. It is suggested to conduct a study to obtain evidence of the number of people who take self-medicated aspirin, follow up, and evolution once these recommendations are widely known and implemented(AU)

Ranolazina como terapia antianginosa adicional en pacientes con enfermedad coronaria estable sintomática / Ranolazine as an additional antianginal therapy in patients with stable symptomatic coronary artery disease

INTRODUCCIÓN: La enfermedad coronaria estable posee varios tratamientos con beneficio probado tanto en mortalidad como en incidencia de eventos agudos. Sin embargo, el control de los síntomas, especialmente en aquellos que no responden a terapia de primera línea, sigue siendo controvertido. Este resumen pretende evaluar el papel de la ranolazina como terapia adicional al tratamiento antianginoso estándar en pacientes que persisten sintomáticos a pesar de éste. MÉTODOS: Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES: Identificamos cuatro revisiones sistemáticas que en conjunto incluyeron 16 estudios primarios, todos correspondientes a ensayos aleatorizados, de los cuales cuatro son atingentes para la pregunta específica. Concluimos que en pacientes con enfermedad coronaria estable que persisten sintomáticos a pesar de terapia antianginosa estándar, el tratamiento adicional con ranolazina podría disminuir los episodios de angina semanales pero aumentando la incidencia de efectos adversos, y resulta en poca o nula diferencia en el riesgo de muerte o infarto agudo al miocardio.

INTRODUCTION: There are several effective therapeutic alternatives for stable coronary artery, in terms of prevention of cardiovascular morbidity and mortality. However, the best way to achieve symptomatic control is a matter of debate, particularly in those who do not respond to first-line therapy. This summary aims to evaluate the role of ranolazine as an additional therapy to standard antianginal treatment in patients with persistent symptoms. METHODS: To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach. RESULTS AND CONCLUSIONS: We identified four systematic reviews including 16 studies overall, all of which were randomized trials. We concluded additional treatment with ranolazine might decrease the frequency of anginal episodes but increase adverse effects. It probably has no effect on the risk of death or acute myocardial infarction.

Perfil contemporâneo da intervenção coronária percutânea em octogenários / Contemporary profile of percutaneous coronary intervention in octogenarians

Introdução: Com o aumento da longevidade observado nas últimas décadas, as intervenções coronárias percutâneas (ICP) em octogenários são cada vez mais indicadas. Objetivo: Traçar o perfil clínico-epidemiológico-angiográfico e os principais detalhes associados à ICP dos pacientes octogenários. Métodos: Cento e cinquenta pacientes octogenários foram submetidos à ICP entre janeiro de 2015 a dezembro de 2016, no Instituto Dante Pazzanese de Cardiologia, correspondendo a 3,7% dos 3987 casos tratados e a 18% dos com idade >70 anos, e incluídos de forma sequencial e prospectiva. Não houve critérios de exclusão. Os resultados clínicos expostos foram restritos à fase hospitalar. Resultados: A maioria (63%) era do sexo masculino, com idade média de 86±3,9 anos (máximo de 102 anos). Do total de pacientes, 91,3% eram hipertensos, 37,4% diabéticos, a ICP prévia foi realizada em para 17,4%, enquanto 34,1% apresentaram infarto prévio. A cinecoronariografia identificou que 70,4% eram multiarteriais, dos quais 4% exibiam lesões não pro - tegidas do tronco da coronária esquerda. A maioria (55%) apresentava disfunção ventricular significativa. Stents farmacológicos (SF) foram utilizados em 97,2% dos casos. O sucesso angiográfico foi obtido em 97,5% e o sucesso clínico em 93,2%. A mortalidade e o infarto ocorreram abaixo de 4,3% dos casos. Conclusão: Nessa população, observaram-se que os pacientes octogenários constituíram a minoria dos idosos tratados; a doença multiarterial grave foi o achado predominante; os stents farmacológicos foram implantados quase em todos os casos e os sucessos angiográfico e clínico apresentaram-se elevado

With the increase in longevity observed in recent decades, percutaneous coronary interventions (PCI) in octogenarians are increasingly indicated. Objective: To outline the clinical, epidemiological and angiographic profile and main details associated with PCI in octogenarian patients. Methods: One hundred and fifty octogenarian patients underwent PCI between January 2015 and December 2016 at the Dante Pazzanese In - stitute of Cardiology, corresponding to 3.7% of the 3987 cases treated and 18% of those aged> 70 years, and included sequentially and prospectively. There were no exclusion criteria. The clinical results were restricted to the hospital phase. Results: The majority (63%) were males, with a mean age of 86±3.9 years (maximum 102 years). Of the total patients, 91.3% were hypertensive, 37.4% were diabetic, 17.4% had previously undergone PCI, while 34.1% had previous infarction. The coronary angiography indicated that 70.4% were multiarterial, of which 4% had unprotected lesions of the trunk of the left coronary artery. The majority (55%) had significant ventricular dysfunction. Pharmacological stents were used in 97.2% of the cases. Angiographic success was achieved in 97.5% and clinical success in 93.2%. Mortality and infarction occurred in less than 4.3% of the cases. Conclusion: In this population, it was observed that octogenarian patients constituted a minority of treated elderly; severe multivessel disease was the predominant finding; pharmacological stents were implanted in almost all cases, and angiographic and clin

Razões para não adesão a fármacos em pacientes com doença arterial coronariana / Reasons for medication noncompliance in patients with coronary artery disease

OBJETIVO: Descrever as razões da não adesão ao tratamento medicamentoso em pacientes com doença arterial coronariana crônica; a prevalência de não adesão às drogas; e os perfis clínico, social e econômico dos pacientes. MÉTODOS: Estudo transversal, prospectivo e descritivo realizado de julho a dezembro de 2015, com 130 pacientes (75% homens; idade 60,8±10,3 anos). As características clínicas dos pacientes foram coletadas por questionário clínico e a adesão medicamentosa por questionário de Morisky-Green. Foram realizadas análises estatísticas descritivas das variáveis. RESULTADOS: Noventa e seis pacientes (74%) foram não aderentes. A principais razões para não adesão foram: dificuldade em identificar o medicamento tomado em 86,4%% dos pacientes; destes, 43,3% relataram não saber o nome da medicação de que faziam uso contínuo, 27,7% relataram que o controle era feito pelo familiar, 15,6% identificavam o medicamento pelo tamanho e pela cor. Dos 96 pacientes não aderentes, 40% citaram o esquecimento como o maior motivo para a não aderência à terapia farmacológica, 11,4% citaram as condições financeiras. CONCLUSÃO: A prevalência de não adesão medicamentosa foi elevada, e as principais razões para não tomada adequada das medicações pelos pacientes foram: dificuldade na identificação dos medicamentos, esquecimento de tomar o remédio e dificuldade em aquisição das drogas.(AU)

OBJECTIVES: To describe the reasons for noncompliance to drug therapy in patients with chronic coronary artery disease; the prevalence of noncompliance to drugs; and patients' clinical, social and economic profile. METHODS: This is a cross-sectional, prospective and descriptive study carried out from July to December 2015, including 130 patients (75% of men, age 60.8±10.3 years). Patients' clinical characteristics were collected through a clinical questionnaire, and drug adherence through the Morisky-Green questionnaire. Descriptive statistical analyzes of the variables were performed. RESULTS: Ninetysix patients (74%) were noncomplaint to the pharmacological treatment. The main reasons for noncompliance were: difficulty in identifying the medication taken in 86.4% of the patients; of these, 43.3% reported not knowing the name of the medication they are taking; 27.7% reported that the control was done by a relative, 15.6% identified the medication by size and color. Of the 96 noncompliant patients, 40% reported forgetting as the main reason for noncompliance to pharmacological therapy, 11.4% mentioned financial conditions. CONCLUSION: The prevalence of noncompliance to drug therapy was high; in addition, the main reasons for not taking adequate medications were: difficulty in identifying medications, forgetting to take the medication, and difficulty in purchasing the drugs.(AU)

Decreased platelet responsiveness to clopidogrel correlates with CYP2C19 and PON1 polymorphisms in atherosclerotic patients

Clopidogrel and aspirin are the most commonly used medications worldwide for dual antiplatelet therapy after percutaneous coronary intervention. However, clopidogrel hyporesponsiveness related to gene polymorphisms is a concern. Populations with higher degrees of genetic admixture may have increased prevalence of clopidogrel hyporesponsiveness. To assess this, we genotyped CYP2C19, ABCB1, and PON1 in 187 patients who underwent percutaneous coronary intervention. Race was self-defined by patients. We also performed light transmission aggregometry with adenosine diphosphate (ADP) and arachidonic acid during dual antiplatelet therapy. We found a significant difference for presence of the CYP2C19*2 polymorphism between white and non-white patients. Although 7% of patients had platelet resistance to clopidogrel, this did not correlate with any of the tested genetic polymorphisms. We did not find platelet resistance to aspirin in this cohort. Multivariate analysis showed that patients with PON1 and CYP2C19 polymorphisms had higher light transmission after ADP aggregometry than patients with native alleles. There was no preponderance of any race in patients with higher light transmission aggregometry. In brief, PON1 and CYP2C19 polymorphisms were associated with lower clopidogrel responsiveness in this sample. Despite differences in CYP2C19 polymorphisms across white and non-white patients, genetic admixture by itself was not able to identify clopidogrel hyporesponsiveness.

Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines

Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.

Myocardial bridging

Abstract Myocardial bridging is rare. Myocardial bridges are most commonly localized in the middle segment of the left anterior descending coronary artery. The anatomic features of the bridges vary significantly. Alterations of the endothelial morphology and the vasoactive agents impact on the progression of atherosclerosis of myocardial bridging. Patients may present with chest pain, myocardial infarction, arrhythmia and even sudden death. Patients who respond poorly to the medical treatment with β-blockers warrant a surgical intervention. Myotomy is a preferred surgical procedure for the symptomatic patients. Coronary stent deployment has been in limited use due to the unsatisfactory long-term results.

Changes in Medical Management after Coronary CT Angiography / Mudanças no Manejo Clínico após Angiotomografia Coronariana

AbstractIntroduction:Coronary computed tomography angiography (CCTA) allows for non-invasive coronary artery disease (CAD) phenotyping. There are still some uncertainties regarding the impact this knowledge has on the clinical care of patients.Objective:To determine whether CAD phenotyping by CCTA influences clinical decision making by the prescription of cardiovascular drugs and their impact on non-LDL cholesterol (NLDLC) levels.Methods:We analysed consecutive patients from 2008 to 2011 submitted to CCTA without previous diagnosis of CAD that had two serial measures of NLDLC, one up to 3 months before CCTA and the second from 3 to 6 months after.Results:A total of 97 patients were included, of which 69% were men, mean age 64 ± 12 years. CCTA revealed that 18 (18%) patients had no CAD, 38 (39%) had non-obstructive (< 50%) lesions and 41 (42%) had at least one obstructive ≥ 50% lesion. NLDLC was similar at baseline between the grups (138 ± 52 mg/dL vs. 135 ± 42 mg/dL vs. 131 ± 44 mg/dL, respectively, p = 0.32). We found significative reduction in NLDLC among patients with obstrctive lesions (-18%, p = 0.001). We also found a positive relationship between clinical treatment intensification with aspirin and cholesterol reducing drugs and the severity of CAD.Conclusion:Our data suggest that CCTA results were used for cardiovascular clinical treatment titration, with especial intensification seen in patients with obstructive ≥50% CAD.

ResumoFundamento:A Angiotomografia Coronariana (AngioTC Cor) permite a fenotipagem de Doença Arterial Coronariana (DAC) de forma não invasiva. Ainda há incertezas sobre o impacto que esse conhecimento promove no tratamento clínico do paciente.Objetivo:Avaliar se a fenotipagem da DAC por AngioTC Cor influencia na tomada de decisão sobre o início da terapêutica cardiovascular e seu impacto nos níveis séricos de colesterol não HDL (CNHDL).Métodos:Foram analisados pacientes consecutivos sem diagnóstico prévio de DAC que realizaram AngioTC Cor entre os anos 2008 e 2011 e que possuíam duas dosagens seriadas de colesterol até três meses antes da AngioTC Cor, e de três a seis meses após.Resultados:Um total de 97 pacientes foram incluídos, sendo 69% homens, idade média de 64 ± 12 anos. A AngioTC Cor revelou que 18 (18%) pacientes não tinham lesões detectáveis, 38 (39%) tinham lesões não obstrutivas < 50%, e 41 (42%) tinham ao menos uma lesão obstrutiva ≥ 50%. As medidas de CNHDL basal foram similares entre os grupos, (138 ± 52 mg/dL vs. 135 ± 42 mg/dL vs. 131 ± 44 mg/dL, respectivamente, p = 0,32). Observou-se redução significativa do CNHDL apenas no grupo com lesões obstrutivas ≥ 50% (-18%, p = 0,001). Observa-se ainda relação entre a intensificação do tratamento clínico com AAS e drogas redutoras de colesterol proporcional à gravidade da DAC pela AngioTC Cor.Conclusão:Esses dados sugerem que o resultado da AngioTC Cor foi utilizado para a titulação terapêutica de pacientes com DAC, sendo o tratamento intensificado especialmente em DAC obstrutiva ≥ 50%.

Reduced Progression of Cardiac Allograft Vasculopathy with Routine Use of Induction Therapy with Basiliximab / Redução da Progressão da Doença Vascular do Enxerto Cardíaco com o Uso Rotineiro da Terapia de Indução com Basiliximab

AbstractIntroduction:Cardiac allograft vasculopathy (CAV) is a major limitation for long-term survival of patients undergoing heart transplantation (HT). Some immunosuppressants can reduce the risk of CAV.Objectives:The primary objective was to evaluate the variation in the volumetric growth of the intimal layer measured by intracoronary ultrasound (IVUS) after 1 year in patients who received basiliximab compared with that in a control group.Methods:Thirteen patients treated at a single center between 2007 and 2009 were analyzed retrospectively. Evaluations were performed with IVUS, measuring the volume of a coronary segment within the first 30 days and 1 year after HT. Vasculopathy was characterized by the volume of the intima of the vessel.Results:Thirteen patients included (7 in the basiliximab group and 6 in the control group). On IVUS assessment, the control group was found to have greater vessel volume (120–185.43 mm3 vs. 127.77–131.32 mm3; p = 0.051). Intimal layer growth (i.e., CAV) was also higher in the control group (27.30–49.15 mm3 [∆80%] vs. 20.23–26.69 mm3[∆33%]; p = 0.015). Univariate regression analysis revealed that plaque volume and prior atherosclerosis of the donor were not related to intima growth (r = 0.15, p = 0.96), whereas positive remodeling was directly proportional to the volumetric growth of the intima (r = 0.85, p < 0.001).Conclusion:Routine induction therapy with basiliximab was associated with reduced growth of the intima of the vessel during the first year after HT.

ResumoFundamento:A doença vascular do enxerto (DVE) constitui uma grande limitação de sobrevida a longo prazo de pacientes submetidos a transplante cardíaco (TxC). Alguns imunossupressores diminuem o aparecimento da DVE.Objetivos:O principal objetivo foi avaliar, através de ultrassonografia intracoronária (USIC), a variação do crescimento volumétrico da camada íntima e comparar, após um ano, o grupo que recebeu basiliximab com um grupo de controle.Métodos:Treze pacientes de um único centro foram analisados retrospectivamente de 2007 a 2009. As análises foram feitas através de USIC, medindo-se o volume de um segmento coronariano nos primeiros 30 dias e um ano após o TxC. A vasculopatia foi caracterizada pelo volume da camada íntima do vaso.Resultados:O estudo incluiu 13 pacientes (7 no grupo com o basiliximab e 6 no grupo de controle). A análise por USIC revelou que o grupo de controle apresentou maior crescimento volumétrico do vaso (131,32 a 127,77 mm3 x 120 a 185,43 mm3 p = 0,051). O crescimento da camada íntima (CCI) também foi maior no grupo de controle [Basiliximab: 20,23 a 26,69 mm3 (∆ 33%); Controle: 27,30 a 49,15 mm3(∆ 80% p = 0,015)]. De acordo com a regressão univariada, o volume da placa aterosclerótica prévia do doador não teve relação com o crescimento da íntima (r = 0,15, p = 0,96), enquanto que o remodelamento positivo do vaso foi diretamente proporcional ao crescimento da íntima (r = 0,85, p < 0,001).Conclusão:A terapia de indução de rotina com basiliximab está associada à redução do crescimento da camada íntima do vaso no primeiro ano após o transplante cardíaco.

Association between LDL-C, Non HDL-C, and Apolipoprotein B Levels with Coronary Plaque Regression / Associação entre Níveis De LDL-C, Não-HDL-C E Apolipoproteína B com Regressão de Placa Coronariana

Previous reports have inferred a linear relationship between LDL-C and changes in coronary plaque volume (CPV) measured by intravascular ultrasound. However, these publications included a small number of studies and did not explore other lipid markers.

Estudos prévios sugerem uma relação linear entre o LDL-C e mudanças no volume de placa coronariana (VPC) medido por ultrassonografia intravascular. No entanto, estas publicações incluíram um número pequeno de estudos e não exploraram outros marcadores lipídicos.

Resultados Tardios de Pacientes Submetidos a Implante de Stents Farmacológicos do Registro SAFIRA / Late Outcomes of Patients Undergoing Drug-Eluting Stent Implantation ? The SAFIRA Registry

Introdução: A doença arterial coronária continua sendo um dos maiores problemas de saúde pública da atualidade e a intervenção coronária percutânea com stents farmacológicos é a forma mais frequente de tratamento desses pacientes. O objetivo deste estudo foi avaliar a taxa de desfechos clínicos no seguimento clínico de até 10 anos dos pacientes tratados com stents farmacológicos. Métodos: Pacientes com indicação de ICP foram incluídos de forma prospectiva, independentemente do quadro clínico ou angiográfico de apresentação. O desfecho primário consistiu na avaliação da taxa de eventos cardíacos adversos maiores combinados (óbito cardíaco, infarto agudo do miocárdio não fatal ou necessidade de revascularização do vaso alvo guiada por isquemia) no seguimento clínico tardio. Resultados: No período 2002 a 2012, incluímos 1.632 pacientes, com idade de 64,3 ± 10,9 anos, 71,4% eram do sexo masculino e 31,2% portadores de diabetes mellitus. As taxas de sucesso angiográfico e clínico foram de 99,1% e 96,7%, respectivamente. O seguimento clínico foi realizado em 95,8% dos elegíveis em um tempo médio de seguimento de 3,4 ± 2,6 anos. O desfecho primário ocorreu em 246 pacientes (15,9%), com taxas de óbito cardíaco de 6,4%, infarto do miocárdio de 3,6% e revascularização do vaso alvo de 5,5%. A trombose do stent foi verificada em 40 pacientes (2,4%). Conclusões: Nesta experiência da prática clínica diária, a utilização dos stents farmacológicos demonstrou resultados clínicos favoráveis agudos e no longo prazo no tratamento de uma população não selecionada de pacientes com doença arterial coronária e graus variáveis de complexidade clínica e angiográfica.

Background: Coronary artery disease remains a major public healthcare problem worldwide and percutaneous coronary intervention with drug-eluting stents is the most frequent treatment option for these patients. The objective of this study was to evaluate the rate of clinical events in up to 10 years of clinical follow-up of patients treated with drug-eluting stents. Methods: We prospectively enrolled patients with an indication for percutaneous coronary intervention despite their clinical or angiographic presentation. The primary endpoint consisted of the evaluation of the composite rate of major adverse cardiac events (cardiac death, non-fatal acute myocardial infarction or the need of ischemia guided target vessel revascularization) in the late clinical follow-up. Results: From 2002 to 2012, we included 1,632 patients with mean age of 64.3 ± 10.9 years, 71.4% were male and 31.2% had diabetes mellitus. The angiographic and clinical success rates were 99.1% and 96.7%, respectively. Follow-up was obtained in 95.8% of the eligible patients at a mean of 3.4 ± 2.6 years. The primary endpoint was observed in 246 patients (15.9%), with rates of cardiac death of 6.4%, myocardial infarction of 3.6% and target vessel revascularization of 5.5%. Stent thrombosis was observed in 40 patients (2.4%). Conclusions: In this clinical practice experience the use of drug-eluting stents demonstrated favorable acute and long-term results in the treatment of a non-selected population of patients with coronary artery disease and variable degrees of clinical and angiographic complexity.

Stent farmacológico para o tratamento da doença arterial coronariana (DAC) / Pharmacological Stent for the Treatment of Coronary Artery Disease (CAD)

CONTEXTO: A Doença Arterial Coronariana (DAC) é em 90% dos casos, resultante da oclusão ou do estreitamento das artérias coronarianas. Os objetivos do tratamento da DAC são prevenir o Infarto agudo do miocárdio (IAM), reduzir a mortalidade, os sintomas e a ocorrência da isquemia miocárdica. Esses objetivos podem ser atingidos por modificações do estilo de vida, tratamento clínico ou por meio de revascularização do miocárdio, realizada por Cirurgia de Revascularização Miocárdica (CRVM) ou Intervenção Coronariana Percutânea (ICP). As ICPs se referem a um grupo de técnicas utilizadas para restaurar o fluxo nas artérias coronarianas obstruídas, incluindo a angioplastia coronária transluminal percutânea (PTCA) com ou sem implante de stent, que podem ser convencionais ou farmacológicos. Atualmente o Sistema Único de Saúde disponibiliza somente stents convencionais. TRATAMENTO RECOMENDADO: Um guia elaborado no sistema de saúde britânico pelo National Institute for Health and Clinical Excellence (NICE) publicado em 2003 e atualizado em 2008 descreve que para intervenção coronariana percutânea (ICP) é recomendado o uso de stent farmacológico nos casos em que a artéria alvo tenha menos de três mm de calibre (diâmetro interno) ou a lesão seja maior do que 15 mm, e a diferença de preço entre o stent farmacológico e o stent convencional seja menor que £300 (NICE 2003; NICE, 2008). A TECNOLOGIA: Dispositivo intra-coronariano (stent) - Utilização do dispositivo stent farmacológico na intervenção coronária percutânea por meio da realização de angioplastia coronária ­ método não cirúrgico ­ para a desobstrução das artérias coronárias na presença de estenoses significativas. EVIDÊNCIAS CIENTÍFICAS: As evidências científicas de eficácia apresentadas pelo demandante foram consideradas inadequadas. Busca suplementar incluiu quatorze revisões sistemáticas que avaliaram a comparação de stent farmacológico vs. stent convencional, das quais quatro avaliaram exclusivamente stent eluidor de sirolimo vs. stent convencional e uma avaliou exclusivamente stent eluidor de paclitaxel vs. stent convencional. Não houve diferença estatisticamente significante entre os pacientes que receberam stent farmacológico ou stent convencional nos dez estudos que avaliaram a mortalidade em qualquer que fosse o tempo de seguimento - que variou entre seis meses e cinco anos. Não houve diferença estatisticamente significante entre os pacientes que receberam stent farmacológico ou stent convencional em dez estudos que avaliaram a incidência de Infarto Agudo do Miocárdio (IAM) em até cinco anos de acompanhamento. Em todos os estudos, os stents farmacológicos (stent eluidor de sirolimo e stent eluidor de paclitaxel) apresentaram menor taxa de reintervenção que o stent convencional, em qualquer tempo de seguimento. Dez estudos avaliaram o risco de trombose entre pacientes que receberam stents farmacológicos comparado a pacientes que receberam stent convencional. CONSIDERAÇÕES FINAIS: Com relação à evidência científica baseada em ensaios clínicos randomizados e controlados e revisões sistemáticas com metanálise, os stents farmacológicos eluidores de sirolimo ou paclitaxel não apresentaram superioridade aos stents convencionais, demonstrando benefícios apenas em relação aos eventos cardiovasculares adversos maiores e à taxa de reintervenção. Para a avaliação econômica, estudos realizados em outros países têm demonstrado que o stents farmacológicos apresentam relação custo-efetividade favorável ao stent convencional somente em pacientes de alto risco cardiovascular, tais como diabéticos e pacientes com lesões de calibre inferir a 2,5 mm e extensão maior do que 18 mm. Estudos realizados no Brasil demonstraram que o uso do stent farmacológico não apresenta uma razão de custo-efetividade favorável na perspectiva do SUS com base nos preços do referido produto no mercado nacional. 7. DELIBERAÇÃO FINAL: Na 25ª Reunião da CONITEC, realizada nos dias 07 e 08/05/2014, os membros do plenário deliberaram por unanimidade recomendar a incorporação do stent farmacológico coronariano em pacientes diabéticos e pacientes com lesões em vasos finos (lesões de calibre inferior a 2,5 mm e extensão maior do que 18 mm), condicionada ao mesmo valor de ressarcimento da tabela de procedimento do SUS para o stent convencional, que é atualmente de R$ 2.034,50 (dois mil e trinta e quatro reais e cinquenta centavos). DECISÃO: PORTARIA Nº 29, de 27 de agosto de 2014 - Torna pública a decisão de incorporar o stent farmacológico coronariano em pacientes diabéticos e pacientes com lesões em vasos finos (lesões de calibre inferior a 2,5 mm e extensão maior do que 18 mm), condicionada ao mesmo valor de ressarcimento da tabela de procedimento do SUS para o stent convencional, que é atualmente de R$ 2.034,50 (dois mil e trinta e quatro reais e cinquenta centavos) no âmbito do Sistema Único de Saúde - SUS.

Long-Term Outcomes of Complete Versus Incomplete Revascularization for Patients with Multivessel Coronary Artery Disease and Left Ventricular Systolic Dysfunction in Drug-Eluting Stent Era

We aimed to investigate that complete revascularization (CR) would be associated with a decreased mortality in patients with multivessel disease (MVD) and reduced left ventricular ejection fraction (LVEF). We enrolled a total of 263 patients with MVD and LVEF <50% who had undergone percutaneous coronary intervention with drug-eluting stent between March 2003 and December 2010. We compared major adverse cardiac and cerebrovascular accident (MACCE) including all-cause death, myocardial infarction, any revascularization, and cerebrovascular accident between CR and incomplete revascularization (IR). CR was achieved in 150 patients. During median follow-up of 40 months, MACCE occurred in 52 (34.7%) patients in the CR group versus 51 (45.1%) patients in the IR group (P=0.06). After a Cox regression model with inverse-probability-of-treatment-weighting using propensity score, the incidence of MACCE of the CR group were lower than those of the IR group (34.7% vs. 45.1%; adjusted hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.44-0.95, P=0.03). The rate of all-cause death was significantly lower in patients with CR than in those with IR (adjusted HR, 0.48; 95% CI, 0.29-0.80, P<0.01). In conclusion, the achievement of CR with drug-eluting stent reduces long-term MACCE in patients with MVD and reduced LVEF.

Prevalência de alta reatividade plaquetária em pacientes tratados com aspirina encaminhados para angiografia coronária / Prevalence of high platelet reactivity in aspirin-treated patients referred for coronary angiography

FUNDAMENTO: A aspirina (Ácido Acetilsalicílico - AAS) é capaz de reduzir eventos adversos cardiovasculares em pacientes portadores de Doença Arterial Coronariana (DAC) através da inibição da atividade plaquetária. Alguns pacientes com DAC, apesar da terapia com AAS, apresentam Alta Reatividade Plaquetária (ARP), o que determina um maior risco para o desenvolvimento de eventos cardiovasculares. OBJETIVO: O objetivo deste estudo foi determinar a prevalência de ARP em pacientes tratados com AAS e encaminhados para cinecoronariografia, além de avaliar se existe uma possível correlação entre a gravidade da DAC e o desenvolvimento de ARP. MÉTODOS: Estudo de centro único onde foram incluídos 115 pacientes consecutivos, tratados com AAS e portadores de DAC estável. A reatividade plaquetária induzida pelo ADP e colágeno foram avaliadas através da Agregometria de Transmitância Luminosa (ATL). Pacientes com agregação plaquetária maior que 70%, induzida por ambos os reagentes, foram classificados como tendo ARP e, neste grupo, a adesão ao tratamento com AAS foi avaliada através da dosagem dos níveis séricos de salicilato. RESULTADOS: A média de idade foi de 60,9 anos e a dose média de AAS foi de 164,2 mg. Tabagismo e diabetes melito estavam presentes em 28,7% e 31,5% dos pacientes, respectivamente. Foi encontrada ARP em 14 pacientes (13%), entretanto, em sete indivíduos (50%) com ARP observaram-se baixos níveis séricos de salicilato (< 2,0 µg/mL), sugerindo não adesão à terapia medicamentosa. Em 6,5% dos pacientes com ARP identificou-se níveis detectáveis de salicilato sérico, sugerindo uma eficácia reduzida do AAS. A ARP se correlacionou com o número e a gravidade das estenoses coronárias (p = 0,04). CONCLUSÃO: Em uma população de pacientes tratados com AAS e encaminhados para angiografia coronária, a reatividade plaquetária elevada é prevalente (13%), sendo 50% destes pacientes não aderentes à terapia farmacológica e 50% apresentam redução da efetividade da droga.

BACKGROUND: Aspirin (ASA) reduces adverse events in coronary artery disease (CAD) patients by inhibiting platelets. Some CAD patients have high platelet reactivity (HPR) despite ASA therapy and these individuals have increased risk of adverse events. OBJECTIVE: The purpose of this study was to determine the prevalence of HPR in ASA-treated patients referred for coronary angiography and to assess whether the HPR correlates with the severity of CAD. METHODS: This single center investigation enrolled 115 consecutive ASA-treated patients with stable CAD. ADP- and collagen-induced platelet reactivity were evaluated by light transmittance aggregometry (LTA). Patients with greater than 70% ADP- and collagen-induced aggregation were determined to have HPR and, in this group, ASA compliance was assessed by examining blood salicylate levels. Mean age was 60.9 years and average ASA dose was 164.2 mg. RESULTS: Smoking and DM were present in 28.7% and 31.5% respectively. HPR was found in 14 patients (13%) however 7 of the 14 patients (50%) with HPR had low serum salicylate levels (< 2.0 µg/mL) suggesting medication noncompliance. Of the entire cohort, 6.5% of patients had HPR and detectable serum salicylate levels suggesting reduced ASA efficacy. HPR correlated with number and severity of coronary stenosis (p = 0.04). CONCLUSION: In a general population of ASA-treated patients referred for coronary angiography, elevated platelet reactivity is prevalent (13%) with 50% related to noncompliance and 50% related to reduced aspirin efficacy.

Effects of Low Dose Pioglitazone on Restenosis and Coronary Atherosclerosis in Diabetic Patients Undergoing Drug Eluting Stent Implantation

PURPOSE: Thiazolidinediones are insulin-sensitizing agents that reduce neointimal proliferation and the adverse clinical outcomes associated with percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM). There is little data on whether or not low dose pioglitazone reduces adverse clinical outcomes. MATERIALS AND METHODS: The study population included 121 DM patients with coronary artery disease and they were randomly assigned to 60 patients taking 15 mg of pioglitazone daily in addition to their diabetic medications and 61 patients with placebo after the index procedure with drug-eluting stents (DESs). The primary end points were rate of in-stent restenosis (ISR) and change in atheroma volume and in-stent neointimal volume. The secondary end points were all-cause death, myocardial infarction (MI), stent thrombosis and re-PCI. RESULTS: There were no statistical differences in the clinical outcomes and the rate of ISR between the two groups [all-cause death; n=0 (0%) in the pioglitazone group vs. n=1 (1.6%) in the control group, p=0.504, MI; n=2 (3.3%) vs. n=1 (1.6%), p=0.465, re-PCI; n=6 (10.0%) vs. n=6 (9.8%), p=0.652, ISR; n=4 (9.3%) vs. n=4 (7.5%), p=1.000, respectively]. There were no differences in changes in neointimal volume, percent neointimal volume, total plaque volume and percent plaque volume between the two groups on intravascular ultrasonography (IVUS) study. CONCLUSION: Our study demonstrated that low dose pioglitazone does not reduce rate of ISR, neointimal volume nor atheroma volume in DM patients who have undergone PCI with DESs, despite the limitations of the study.