Preliminary outcomes of endovascular treatment of moyamoya disease.

PURPOSE: This study aimed to investigate the effectiveness and safety of endovascular revascularisation of intracranial artery occlusion and stenosis in moyamoya disease using stent angioplasty. MATERIALS AND METHODS: We recruited 12 patients (8 women and 4 men) with occlusion and stenosis of intracranial arteries in the context of moyamoya disease who underwent endovascular stent angioplasty. Clinical data, baseline conditions, lesion location, treatment outcomes, periprocedural complications, and follow-up outcomes were analysed. RESULTS: The occlusion was located at the M1 segment of the middle cerebral artery in 8 patients, at both the M1 and A2 segments in one patient, and at the C7 segment of the internal carotid artery in 3. Thirteen stents were deployed at the occlusion site, including the low-profile visualized intraluminal support (LVIS) device in 8 patients, an LVIS device and a Solitaire AB stent in one, and a Leo stent in 3, with a success rate of 100% and no intraprocedural complications. Plain CT imaging after stenting revealed leakage of contrast agent, which disappeared on the second day, resulting in no clinical symptoms or neurological sequelae. Follow-up angiography studies were performed in all patients for 6-12 months (mean, 8.8). Slight asymptomatic in-stent stenosis was observed in 2 patients (16.7%), and no neurological deficits were observed in the other patients. All preoperative ischaemic symptoms completely disappeared at follow-up. CONCLUSION: Stent angioplasty is a safe and effective treatment for occlusion and stenosis of intracranial arteries in moyamoya disease.

Coronary stent and prolonged dual antiplatelet therapy. A longitudinal study.

INTRODUCTION: In current European guidelines for the management of myocardial infarction after coronary stent placement, there is no consensus on dual antiplatelet therapy (DAPT) ideal duration to prevent stent thrombosis-restenosis without significantly increasing the bleeding risk. OBJECTIVE: To report the percentage of major bleeding and presence of major cardiovascular events associated with prolonged DAPT in patients recruited at the National Institute of Cardiology, treated with primary percutaneous coronary intervention and stent. METHODS: A longitudinal, prospective, observational, non-experimental, descriptive study was carried out. Patients were recruited from November 2016 to December 2017. RESULTS: One hundred and thirty-five patients with a mean age of 57 ± 10 years who completed the three-year follow-up were selected. Obesity and hypertension stood out as the main risk factors. After using DAPT for three years, 3.7% of mortality, 1.48% of major bleeding, and 4.4% of thrombosis-restenosis were recorded. CONCLUSIONS: Prolonged use of DAPT would be justified by the high incidence of thrombosis-restenosis, without a significant increase in bleeding risk, as well as a decrease in major cardiovascular events.

INTRODUCCIÓN: En las guías actuales europeas para el manejo del infarto de miocardio posterior a la colocación de endoprótesis coronaria (stent), no existe consenso sobre la duración ideal de la terapia antiagregante plaquetaria dual (DAPT, dual antiplatelet therapy) para prevenir la trombosis-reestenosis del stent sin aumentar el riesgo significativo de sangrado. OBJETIVO: Reportar el porcentaje de sangrado mayor y de eventos cardiovasculares mayores asociados a la DAPT prolongada en pacientes atendidos en el Instituto Nacional de Cardiología y tratados con intervención coronaria percutánea primaria y stent. MÉTODOS: Se realizó un estudio longitudinal, prospectivo observacional y descriptivo no experimental. Los pacientes fueron captados de noviembre de 2016 a diciembre de 2017. RESULTADOS: Fueron seleccionados 135 pacientes con una media de edad de 57 ± 10 años, quienes cumplieron un seguimiento clínico por tres años. La obesidad y la hipertensión destacaron como principales factores de riesgo. Posterior al uso de DAPT durante tres años, se registró 3.7 % de mortalidad, 1.48 % de sangrado mayor y 4.4 % de trombosis-reestenosis. CONCLUSIONES: El uso prolongado de DAPT estaría justificado por la alta incidencia de trombosis-reestenosis, sin incremento significativo en el riesgo de sangrado y con disminución de los eventos cardiovasculares mayores.

Endoprótesis coronaria y doble terapia antiplaquetaria prolongada. Un estudio longitudinal / Coronary stent and prolonged dual antiplatelet therapy. A longitudinal study

Resumen Introducción: En las guías actuales europeas para el manejo del infarto de miocardio posterior a la colocación de endoprótesis coronaria (stent), no existe consenso sobre la duración ideal de la terapia antiagregante plaquetaria dual (DAPT, dual antiplatelet therapy) para prevenir la trombosis-reestenosis del stent sin aumentar el riesgo significativo de sangrado. Objetivo: Reportar el porcentaje de sangrado mayor y de eventos cardiovasculares mayores asociados a la DAPT prolongada en pacientes atendidos en el Instituto Nacional de Cardiología y tratados con intervención coronaria percutánea primaria y stent. Métodos: Se realizó un estudio longitudinal, prospectivo observacional y descriptivo no experimental. Los pacientes fueron captados de noviembre de 2016 a diciembre de 2017. Resultados: Fueron seleccionados 135 pacientes con una media de edad de 57 ± 10 años, quienes cumplieron un seguimiento clínico por tres años. La obesidad y la hipertensión destacaron como principales factores de riesgo. Posterior al uso de DAPT durante tres años, se registró 3.7 % de mortalidad, 1.48 % de sangrado mayor y 4.4 % de trombosis-reestenosis. Conclusiones: El uso prolongado de DAPT estaría justificado por la alta incidencia de trombosis-reestenosis, sin incremento significativo en el riesgo de sangrado y con disminución de los eventos cardiovasculares mayores.

Abstract Introduction: In current European guidelines for the management of myocardial infarction after coronary stent placement, there is no consensus on dual antiplatelet therapy (DAPT) ideal duration to prevent stent thrombosis-restenosis without significantly increasing the bleeding risk. Objective: To report the percentage of major bleeding and presence of major cardiovascular events associated with prolonged DAPT in patients recruited at the National Institute of Cardiology, treated with primary percutaneous coronary intervention and stent. Methods: A longitudinal, prospective, observational, non-experimental, descriptive study was carried out. Patients were recruited from November 2016 to December 2017. Results: One-hundred and thirty-five patients with a mean age of 57 ± 10 years who completed the three-year follow-up were selected. Obesity and hypertension stood out as the main risk factors. After using DAPT for three years, 3.7% of mortality, 1.48% of major bleeding, and 4.4% of thrombosis-restenosis were recorded. Conclusions: Prolonged use of DAPT would be justified by the high incidence of thrombosis-restenosis, without a significant increase in bleeding risk, as well as a decrease in major cardiovascular events.

Predictor of in-stent restenosis in patients with drug-eluting stent (PRIDE)- a retrospective cohort study / Predictor de reestenosis intrastent en pacientes con El stent liberador de drogas (PRIDE), un estudio de cohorte retrospective

Background: It is a fact that coronary artery disease (CAD) is more prevalent in India as compared to western countries. The major risk factors associated with the early CAD are a high prevalence of diabetes mellitus, atherogenic lipid profile, smoking habits, sedentary lifestyle, low socioeconomic condition and high prevalence of obesity. Is this true for restenosis after drug-eluting stent (DES) implantation and factors associated with it? The main objective of the study was to determine the rate of in-stent restenosis (ISR) in patients with DES and risk factors associated with it from our region. Methods: It was a single-center, retrospective cohort study in which 550 patients who underwent DES implantation were included. Patient's demographic data, coronary angiography findings, procedural characteristics and development of ISR were noted. Results: Out of 550 patients, 31 developed ISR with a rate of restenosis of 5.63% and target lesion revascularization (TLR) of 5.63%. On multiple Cox-regression analysis, only diabetes mellitus (DM) (p=0.008, adjusted hazard ratio (HR): 2.757, 95% confidence interval (CI): 1.296–5.863), deployment of stent in the left anterior descending (LAD) artery (p=0.031, adjusted HR: 3.342, 95% CI: 1.115–10.017) and periprocedural complication during percutaneous coronary intervention (p=0.040, adjusted HR: 2.824, 95% CI: 1.049–7.603) were found to be significantly associated with increased risk of ISR. Kaplan–Meier survival analysis of event-free survival for restenosis showed patients with DM had significantly lower event-free survival compared to patients without DM (p=0.005 by log-rank test). Conclusions: In our study, the rate of restenosis after DES implantation was 5.63%. The presence of DM, the stent in the LAD territory and the periprocedural complication is strongly associated with the development of ISR.(AU)

Antecedentes: Es un hecho que la enfermedad de las arterias coronarias (EAC) es más frecuente en la India que en los países occidentales. Los principales factores de riesgo relacionados con la EAC temprana son una alta prevalencia de la diabetes mellitus, el perfil lipídico aterogénico, el hábito de fumar, el sedentarismo, la baja condición socioeconómica y la alta prevalencia de la obesidad. ¿Es esto cierto para la reestenosis después de la implantación de un stent liberador de fármacos (DES) y los factores asociados a ella? El principal objetivo del El estudio fue determinar la tasa de reestenosis intrastent (ISR) en pacientes con DES y los factores de riesgo asociados a ella de nuestra población. Métodos: Fue un estudio de cohorte retrospectivo de un solo centro en el que se incluyeron 550 pacientes que se sometieron a la implantación de DES. Se anotaron los datos demográficos del paciente, los hallazgos de la angiografía coronaria, las características del procedimiento y el desarrollo del ISR. Resultados: De 550 pacientes, 31 desarrollaron ISR con una tasa de reestenosis del 5,63% y una revascularización de la lesión diana (TLR) del 5,63%. En el análisis de regresión de Cox múltiple, sólo la diabetes mellitus (p = 0,008, cociente de riesgo ajustado (CRI): 2,757, intervalo de confianza (IC) del 95%: 1,296-5,863), el despliegue de la endoprótesis en la arteria descendente anterior izquierda (LAD) (p = 0,031, CRI ajustado: 3. 342, IC del 95%: 1.115-10.017) y la complicación periprocedimental durante la intervención coronaria percutánea (p = 0.040, CRI ajustado: 2.824, IC del 95%: 1.049-7.603) se encontraron significativamente asociadas con el aumento del riesgo de ISR. El análisis de Kaplan---Meier de supervivencia libre de eventos para la reestenosis mostró que los pacientes con diabetes mellitus (DM) tenían una supervivencia libre de eventos significativamente menor en comparación con los pacientes sin DM (p = 0,005 por prueba de rango logarítmico)...(AU)

Influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con reestenosis en el stent / Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis

Introducción y objetivos La neoateroesclerosis es una de las causas de la reestenosis en el stent (RS). Nuestro objetivo es evaluar la influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con RS. Métodos Se trata de un análisis conjunto de los subestudios de tomografía de coherencia óptica (OCT) de los RIBS IV y V, 2 ensayos clínicos aleatorizados y multicéntricos que comparan el tratamiento con un balón recubierto con paclitaxel frente al stent liberador de everolimus en pacientes con RS. La evaluación con OCT se realizó basalmente y a los 6-9 meses. La neoateroesclerosis se definió en la OCT basal como una neoíntima con contenido calcificado o lipídico. Se evaluaron los resultados angiográficos y por OCT a los 6-9 meses y la aparición de eventos adversos cardiovasculares mayores a los 3 años de seguimiento en pacientes con y sin neoateroesclerosis tratados con balón recubierto con paclitaxel o stent liberador de everolimus. Resultados Se estudió mediante OCT a 64 pacientes en el momento del procedimiento. Se documentó neoateroesclerosis en 23 lesiones (36%). El seguimiento angiográfico a los 6-9 meses no mostró diferencias entre los pacientes con y sin neoateroesclerosis en reestenosis (5 [24%] frente a 6 [15%]; p=0,49), diámetro luminal mínimo (1,79±0,7 frente a 1,94±0,6 mm; p=0,41) o pérdida tardía (0,33±0,7 frente a 0,15±0,5; p=0,34). El seguimiento con OCT confirmó la ausencia de diferencias en los parámetros cuantitativos y las características del tejido de recubrimiento entre los 2 grupos. A los 3 años de seguimiento, la incidencia de eventos fue de 3 (13%) frente a 5 (12%) en los grupos con y sin neoateroesclerosis respectivamente (HR=0,94; IC95%, 0,22-3,93; p=0,93). Conclusiones En este estudio con una pequeña muestra de pacientes aleatorizados a tratamiento con balón recubierto con paclitaxel o stent liberador de everolimus por RS, ... (AU)

Introduction and objectives Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. Methods This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. Results Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). Conclusions In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR. (AU)

Predictor of in-stent restenosis in patients with drug-eluting stent (PRIDE)- a retrospective cohort study.

BACKGROUND: It is a fact that coronary artery disease (CAD) is more prevalent in India as compared to western countries. The major risk factors associated with the early CAD are a high prevalence of diabetes mellitus, atherogenic lipid profile, smoking habits, sedentary lifestyle, low socioeconomic condition and high prevalence of obesity. Is this true for restenosis after drug-eluting stent (DES) implantation and factors associated with it? The main objective of the study was to determine the rate of in-stent restenosis (ISR) in patients with DES and risk factors associated with it from our region. METHODS: It was a single-center, retrospective cohort study in which 550 patients who underwent DES implantation were included. Patient's demographic data, coronary angiography findings, procedural characteristics and development of ISR were noted. RESULTS: Out of 550 patients, 31 developed ISR with a rate of restenosis of 5.63% and target lesion revascularization (TLR) of 5.63%. On multiple Cox-regression analysis, only diabetes mellitus (DM) (p=0.008, adjusted hazard ratio (HR): 2.757, 95% confidence interval (CI): 1.296-5.863), deployment of stent in the left anterior descending (LAD) artery (p=0.031, adjusted HR: 3.342, 95% CI: 1.115-10.017) and periprocedural complication during percutaneous coronary intervention (p=0.040, adjusted HR: 2.824, 95% CI: 1.049-7.603) were found to be significantly associated with increased risk of ISR. Kaplan-Meier survival analysis of event-free survival for restenosis showed patients with DM had significantly lower event-free survival compared to patients without DM (p=0.005 by log-rank test). CONCLUSIONS: In our study, the rate of restenosis after DES implantation was 5.63%. The presence of DM, the stent in the LAD territory and the periprocedural complication is strongly associated with the development of ISR.

Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis.

INTRODUCTION AND OBJECTIVES: Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. METHODS: This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. RESULTS: Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). CONCLUSIONS: In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR.

Custo-efetividade do Stent Farmacológico na Intervenção Coronariana Percutânea no SUS / Cost-effectiveness of Drug-Eluting Stents in Percutaneous Coronary Intervention in Brazils Unified Public Health System (SUS)

Resumo Fundamento O uso do stent farmacológico (SF) comparado ao stent não farmacológico (SNF) na intervenção coronariana percutânea (ICP) reduziu o percentual de reestenose, porém sem impacto na mortalidade, com aumento no custo. A literatura carece de estudos randomizados que comparem economicamente esses dois grupos de stents na realidade do Sistema Único de Saúde (SUS). Objetivo Estimar a razão custo-efetividade incremental (RCEI) entre SF e SNF na coronariopatia uniarterial em pacientes do SUS Métodos Pacientes com coronariopatia uniarterial sintomática foram randomizados em 3 anos para uso de SF ou SNF durante a ICP, na proporção de 1:2, com seguimento clínico de 12 meses. Foram avaliados reestenose intrastent (RIS), revascularização da lesão-alvo (RLA), eventos adversos maiores e custo-efetividade (CE) de cada grupo. Os valores de p < 0,05 foram considerados significativos. Resultados No grupo SF, dos 74 pacientes (96,1%) que completaram o acompanhamento, ocorreu RIS em 1(1,4%), RLA em 1 (1,4%), óbito em 1 (1,4%), sem trombose. No grupo SNF, dos 141 pacientes (91,5%),ocorreu RIS em 14 (10,1%), RLA em 10 (7,3%), óbito em 3 (2,1%) e trombose em 1 (0,74%). Na análise econômica, o custo do procedimento foi de R$ 5.722,21 no grupo SF e de R$4.085,21 no grupo SNF. A diferença de efetividade a favor do grupo SF por RIS e RLA foi 8,7% e 5,9%, respectivamente, com RCEI de R$ 18.816,09 e R$ 27.745,76. Conclusões No SUS, o SF foi custo-efetivo, em concordância com o limiar de CE preconizado pela Organização Mundial da Saúde. (Arq Bras Cardiol. 2020; 115(1):80-89)

Abstract Background The use of drug-eluting stents (DESs), compared with bare-metal stents (BMSs), in percutaneous coronary intervention (PCI) has reduced the rate of restenosis, without an impact on mortality but with an increase in costs. Medical literature lacks randomized studies that economically compare these 2 stent types within the reality of the Brazilian Unified Public Health System (SUS). Objective To estimate the incremental cost-effectiveness ratio (ICER) between DES and BMS in SUS patients with single-vessel coronary artery disease. Methods Over a 3-year period, patients with symptomatic single-vessel coronary artery disease were randomized in a 1:2 ratio to receive a DES or BMS during PCI, with a 1-year clinical follow-up. The evaluation included in-stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness for each group. P-values <0.05 were considered significant. Results In the DES group, of 74 patients (96.1%) who completed the follow-up, 1 developed ISR (1.4%), 1 had TLR (1.4%), and 1 died (1.4%), with no cases of thrombosis. In the BMS group, of 141 patients (91.5%), ISR occurred in 14 (10.1%), TLR in 10 (7.3%), death in 3 (2.1%), and thrombosis in 1 (0.74%). In the economic analysis, the cost of the procedure was R$ 5,722.21 in the DES group and R$ 4,085.21 in the BMS group. The effectiveness by ISR and TLR was 8.7% for DES and 5.9% for BMS, with an ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Conclusions In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol. 2020; 115(1):80-89)

Do outcomes following intervention for drug-eluting stent restenosis depend on whether the restenosed stent was polymer-free or polymer-coated?

INTRODUCTION AND OBJECTIVES: Outcomes of patients undergoing percutaneous intervention for drug-eluting stent (DES) restenosis are poorer than those in patients with bare-metal stent restenosis. It is unknown if this is related to the presence of polymer coating. We sought to compare outcomes after interventions for in-stent restenosis (ISR) of polymer-free DES vs durable polymer DES. METHODS: Patients enrolled in the ISAR-TEST 5 randomized trial who underwent repeat percutaneous intervention for ISR during follow-up were included. Angiographic outcomes at 6 to 8 months and clinical outcomes at 2 years were analyzed and compared between 2 groups according to whether the restenosed stent was a polymer-free or a durable polymer DES. Multivariate analysis was used to adjust for differences between groups. RESULTS: A total of 326 patients with ISR were included: 220 with ISR in polymer-free DES and 106 with ISR in durable polymer DES. Angiographic follow-up was available for 83.4% of patients. No difference was observed in recurrent binary restenosis between the 2 groups (31.7% vs 27.0%; P=.38; Padjusted=.29). At 2 years, the composite of death, myocardial infarction, or repeat target lesion revascularization were similar between the 2 groups (35.7% vs 34.0%; HR=1.04, 95%CI, 0.70-1.55; P=.83; Padjusted=.79). The rate of repeat target lesion revascularization was also similar in the 2 groups (29.8% vs 31.5%; HR=0.91, 95%CI, 0.60-1.39; P=.68; Padjusted=.62). CONCLUSIONS: In patients undergoing reintervention for DES-ISR, we found no evidence of differences in outcomes according to whether the restenosed stent was a polymer-free or durable polymer DES.

Epicardial fat thickness correlates with coronary in-stent restenosis in patients with acute myocardial infarction.

OBJECTIVE: To determine the relation between epicardial fat thickness and coronary in-stent restenosis in patients with acute myocardial infarction and percutaneous coronary intervention. METHODS: A prospective study was conducted, which included 129 patients (67.3% male, mean age 62.9±10 years) with ST segment elevation acute myocardial infarction undergoing primary percutaneous coronary intervention with bare metal stent. Patients were divided in two groups according to the presence (n=21) or not (n=108) of in-stent restenosis during one year follow-up. RESULTS: Epicardial fat was significantly thicker in patients with coronary in-stent restenosis (5.51±1.6 vs 4.14±2.0mm, p=0.006). A proportionally and significantly thicker epicardial fat was found according to the increase in coronary disease severity (3.3±0.9mm vs 4.3±1.8mm vs 4.7±2.3mm vs 6.7±2.2mm, for type A, B1, B2 and C lesions, respectively, p=0.001) and number of vessels (3.07±1.2mm vs 4.92±1.8mm vs 5.43±2.2mm, for one, two and three vessels disease, respectively, p<0.0001). Epicardial fat thickness ≥4.7mm had 75.0% sensibility and 69.0% specificity for predicting restenosis (AUC=0.737). CONCLUSIONS: Echocardiographic evaluation of epicardial fat thickness could identify those patients with acute myocardial infarction with greater probabilities of in-stent restenosis after percutaneous coronary intervention.

Effects of Rosuvastatin on Apolipoprotein J in Balloon-Injured Carotid Artery in Rats / Efeitos da Rosuvastatina sobre Apolipoproteína J em Artérias de Ratos Lesionadas com Balão

Abstract Background: Restenosis after percutaneous coronary intervention in coronary heart disease remains an unsolved problem. Clusterin (CLU) (or Apolipoprotein [Apo] J) levels have been reported to be elevated during the progression of postangioplasty restenosis and atherosclerosis. However, its role in neointimal hyperplasia is still controversial. Objective: To elucidate the role Apo J in neointimal hyperplasia in a rat carotid artery model in vivo with or without rosuvastatin administration. Methods: Male Wistar rats were randomly divided into three groups: the control group (n = 20), the model group (n = 20) and the statin intervention group (n = 32). The rats in the intervention group were given 10mg /kg dose of rosuvastatin. A 2F Fogarty catheter was introduced to induce vascular injury. Neointima formation was analyzed 1, 2, 3 and 4 weeks after balloon injury. The level of Apo J was measured by real-time PCR, immunohistochemistry and western blotting. Results: Intimal/medial area ratio (intimal/medial, I/M) was increased after balloon-injury and reached the maximum value at 4weeks in the model group; I/M was slightly increased at 2 weeks and stopped increasing after rosuvastatin administration. The mRNA and protein levels of Apo J in carotid arteries were significantly upregulated after rosuvastatin administration as compared with the model group, and reached maximum values at 2 weeks, which was earlier than in the model group (3 weeks). Conclusion: Apo J served as an acute phase reactant after balloon injury in rat carotid arteries. Rosuvastatin may reduce the neointima formation through up-regulation of Apo J. Our results suggest that Apo J exerts a protective role in the restenosis after balloon-injury in rats.

Resumo Fundamento: A reestenose após intervenção coronária percutânea (ICP) após doença coronariana continua um problema não solucionado. Estudos relataram que os níveis de clusterina (CLU), também chamada de apolipoproteína (Apo) J, encontram-se elevados na progressão da reestenose pós-angioplastia e na aterosclerose. Contudo, seu papel na hihperplasia neointimal ainda é controverso. Objetivo: Elucidar o papel da Apo J na hiperplasia neointimal na artéria carótida utilizando um modelo experimental com ratos in vivo, com e sem intervenção com rosuvastatina. Métodos: ratos Wistar machos foram divididos aleatoriamente em três grupos - grupo controle (n = 20), grupo modelo (n = 20), e grupo intervenção com estatina (n = 32). Os ratos no grupo intervenção receberam 10 mg/kg de rosuvastatina. Um cateter Fogarty 2 F foi introduzido para induzir lesão vascular. A formação de neoíntima foi analisada 1, 2, 3 e 4 semanas após lesão com balão. Concentrações de Apo J foram medidas por PCR em tempo real, imuno-histoquímica e western blotting. Resultados: A razão área íntima/média (I/M) aumentou após a lesão com balão e atingiu o valor máximo 4 semanas pós-lesão no grupo modelo; observou-se um pequeno aumento na I/M na semana 2, que cessou após a administração de rosuvastatina. Os níveis de mRNA e proteína da Apo J nas artérias carótidas aumentaram significativamente após administração de rosuvastatina em comparação ao grupo modelo, atingindo o máximo na semana 2, mais cedo em comparação ao grupo modelo (semana 3). Conclusão: A Apo J atuou como reagente de fase aguda após lesão com balão nas artérias carótidas de ratos. A rosuvastatina pode reduzir a formação de neoíntoma por aumento de Apo J. Nossos resultados sugerem que a Apo J exerce um papel protetor na reestenose após lesão com balão em ratos.

Incidence and predictors of reCurrent restenosis after drug-coated balloon Angioplasty for Restenosis of a drUg-eluting Stent: The ICARUS Cooperation.

INTRODUCTION AND OBJECTIVES: The incidence and predictors of recurrent restenosis after drug-coated balloon (DCB) angioplasty for drug-eluting stent (DES) restenosis remain poorly studied. We sought to evaluate the incidence and predictors of recurrent restenosis among participants in randomized controlled trials receiving DCB angioplasty for DES restenosis. METHODS: The clinical and lesion data of individuals enrolled in 6 randomized controlled trials of DCB angioplasty for DES restenosis were pooled. All patients included in this report were assigned to receive paclitaxel-coated balloon angioplasty with the SeQuent Please DCB (B Braun, Melsungen, Germany). The current analysis focused on participants with available follow-up angiography at 6 to 9 months. The incidence of recurrent restenosis, defined as diameter restenosis ≥ 50% in the in-segment area at follow-up angiography, and its clinical and angiographic predictors were evaluated. RESULTS: A total of 546 patients were combined in a single dataset. Angiographic follow-up at 6 to 9 months was available for 484 patients (88.6%) with 518 treated lesions. Recurrent restenosis was detected in 101 (20.8%) patients. On multivariable analysis, lesion length (OR, 1.58; 95%CI, 1.10-2.26; P=.012 for 5mm increase) and vessel size (OR, 1.42; 95%, 1.12-1.79; P=.003 for 0.5mm reduction) were independently associated with recurrent restenosis. CONCLUSIONS: In the largest cohort to date of individuals with angiographic surveillance after DCB angioplasty for DES restenosis, we demonstrated that recurrent restenosis occurs in approximately 1 out of 5 patients. Predictors of recurrent restenosis are increased lesion length and small vessel size.

Evolución de los stents coronarios liberadores de fármacos, de la primera a la cuarta generación / Evolution of coronary drug-eluting stents, from the first to the fourth generation

Resumen Las enfermedades cardiovasculares son la principal causa de muerte a nivel mundial y dentro de éstas se encuentra la enfermedad obstructiva de las arterias coronarias. El tratamiento más común para dicha enfermedad es la angioplastia con stent, que busca recuperar la luz de la arteria y revascularizar al paciente. Desde la aprobación del primer stent metálico la cardiología intervencionista ha experimentado un desarrollo continuo, impulsado por la necesidad de tener alternativas de tratamiento más seguras y eficaces. Dichos avances se reflejan en cuatro generaciones de stents liberadores de fármacos. El presente artículo busca describir las principales características de cada una de estas generaciones.

Abstract Cardiovascular disease is the leading cause of death worldwide and within these the coronary artery disease. The most common treatment for this condition is angioplasty with stent, which seeks to recover the lumen of the artery and revascularization the patient. Since the adoption of the first bare metal stent the area of interventional cardiology has experienced continuous development driven by the need for a safe and effective alternative treatment. These advances are reflecting in four generations of drug-eluting stents. This article aims to describe the main features of each of these generations.

Safety and Efficacy of New Biodegradable Polymer-based Sirolimus-Eluting Stents in a Preclinical Model.

INTRODUCTION AND OBJECTIVES: New drug-eluting stents (DES) designed to overcome the limitations of existing devices should initially be tested in preclinical studies. Our objective was to analyze the safety and efficacy of new biodegradable polymer-based DES compared with bare-metal stents (BMS) and commercially available DES in a model of normal porcine coronary arteries. METHODS: We randomly implanted 101 stents (BMS and biodegradable polymer-based sirolimus-eluting stents: 3 test stent iterations [BD1, BD2, and BD3], Orsiro, Biomime and Biomatrix) in the coronary arteries of 34 domestic pigs. Angiographic and histomorphometric studies were conducted 1 month (n = 83) and 3 months (n = 18) later. RESULTS: The stents were implanted at a stent/artery ratio of 1.31 ± 0.21, with no significant differences between groups. At 1 month, the new test stents (BD1, BD2 and BD3) showed less late loss and angiographic restenosis, as well as lower histologic restenosis and neointimal area (P < .0005), than the BMS. There were no differences in endothelialization, vascular injury, or inflammation between the new test stents and BMS, although the new stents showed higher fibrin deposition (P = .0006). At 3 months, all these differences disappeared, except for a lower neointimal area with the new BD1 stent (P = .027). No differences at any time point were observed between the new test stents and commercially available controls. CONCLUSIONS: In this preclinical model, the new biodegradable polymer-based DES studied showed less restenosis than BMS and no significant differences in safety or efficacy vs commercially available DES.

Optical Coherence Tomography Findings in Patients With Stent Thrombosis.

INTRODUCTION AND OBJECTIVES: Stent thrombosis (ST) is a rare but potentially serious complication. Optical coherence tomography (OCT) provides high-resolution images and additional information to angiography in the study of this event. METHODS: Prospective study of patients with ST undergoing reintervention with OCT imaging. RESULTS: The study included a total of 40 consecutive patients with ST. Mean age was 69 ± 13 years and 83% were male. Early ST (≤ 30 days) was observed in 16 patients and late ST (> 30 days) in 24 patients. Stent thrombosis occurred in 17 bare-metal stents and 23 drug-eluting stents. In 34 patients (85%), adequate OCT images were obtained at the time of the ST. The predominant mechanism in early ST was stent malapposition (39%). In late ST, high frequencies of uncovered (46%) and malapposed struts (17%) were observed, especially in patients with drug-eluting stents. Furthermore, the presence of neoatherosclerosis was very high (67%) in patients with late ST. After intervention, improvements were observed in malapposition length and the amount of residual thrombus. CONCLUSIONS: OCT allows identification of the underlying mechanisms potentially involved in ST. This imaging modality is helpful in guiding reintervention in these patients, which improves the area and length of malapposition, as well as the maximal residual thrombus area.

Restenosis After Everolimus-eluting Vascular Scaffolding. Angiographic and Optical Coherence Tomography Characterization.

INTRODUCTION AND OBJECTIVES: Coronary restenosis after bioresorbable vascular scaffold (BVS) implantation is infrequent and little information is available on the main characteristics of these lesions. The aim of this study was to assess restenotic lesions by using optical coherence tomography (OCT). METHODS: We studied 330 patients with coronary artery disease who received 398 BVS to treat 380 lesions. These patients were clinically and angiographically evaluated at follow-up and OCT was carried out on detection of restenosis. RESULTS: After a follow-up of 19 ± 10 months, 18 restenotic lesions were detected in 17 patients (5.4%). Depending on the time of presentation, most cases of restenosis were late or very late (9 ± 4 months). The most frequent angiographic pattern was focal restenosis in 12 (67%) patients, which was mainly located at the proximal border in 9 (75%) whether involving the scaffold or not. The homogeneous pattern was infrequent, occurring in 3 (25%) lesions and was only visualized in 3 out of 6 cases of restenosis located at the margin. When the focal restenosis was located in the platform, OCT showed a heterogeneous or layered pattern. Finally, diffuse restenosis was observed in 6 patients (33%). In diffuse restenosis, OCT revealed a lipid-laden or layered tissue structure and the presence of microvessels or microcalcification, potentially suggesting a neoatherosclerotic process. CONCLUSIONS: After a mean follow-up of 19 months, the restenosis rate was 5.4%. Most restenotic lesions were focal, located at the proximal border. Diffuse restenosis mostly occurred late or very late and most showed signs suggestive of neoatherosclerosis.

Reestenosis de la arteria coronaria descendente anterior en mujeres diabéticas / Left anterior descending coronary artery restenosis in diabetic women

Resumen Las mujeres diabéticas con la enfermedad arterial coronaria sometidas a revascularización tienen mayor riesgo de reestenosis debido a las alteraciones fisiopatológicas a nivel vascular propias de la diabetes, a la disminución del efecto protector de los estrógenos después de la menopausia y porque el calibre de sus arterias es menor que el de las no diabéticas y menor que el de los hombres. El objetivo de este artículo es comparar la tasa de reestenosis en la arteria coronaria descendente anterior en las mujeres diabéticas que se sometieron a intervención coronaria percutánea más el stent, frente a la cirugía de revascularización. Para ello se realizó una revisión de la literatura utilizando artículos publicados en bases de datos científicas, que compararan las dos técnicas, haciendo énfasis en la población diabética femenina. Encontrando que hubo una ventaja de la cirugía de revascularización sobre la intervención coronaria percutánea en los eventos de revascularización de la lesión diana (OR 0,253, IC 95% 0,092-0,703, p = 0,008) y revascularización del vaso diana (OR 0,185, 95% CI 0,079 a 0,432, p < 0,001), correspondiente a una ventaja en la presentación de evento cardiovascular y cerebrovascular (OR 0,429, CI 95% 0,254-0,723, p = 0,001). Finalmente, se hizo un análisis crítico, concluyendo que la cirugía de revascularización es la técnica de elección en las pacientes diabéticas puesto que tiene una tasa de reestenosis menor y con ello menos eventos adversos que de esta se derivan.

Abstract Women with diabetes and coronary artery disease who undergo revascularization have a higher risk of restenosis due to the pathophysiological alterations at vascular level inherent to diabetes, to the decrease of the protective effect of estrogens after menopause and to the caliber of their arteries being smaller than women without diabetes or men. The goal of this study is to compare the rate of restenosis in anterior descending coronary artery in women with diabetes who underwent percutaneous coronary intervention and the stent, compared to revascularization surgery. For that a literature review was carried out using medical articles published in scientific databases where both techniques were compared, and focusing on female population with diabetes. Results showed there was an advantage for the revascularization surgery versus percutaneous coronary intervention in the revascularization events of the target lesion (OR 0.253, IC 95% 0.092-0.703, p = 0.008) and revascularization of the target vessel (OR 0.185, 95% CI 0.079 a 0.432, p <0.001), corresponding to an advantage in the presentation of the cardiovascular and cerebrovascular event (OR 0.429, CI 95% 0.254-0.723, p = 0.001). Finally, a critical analysis was conducted, thus concluding that revascularization is the chosen technique for female patients with diabetes because of the lower restenosis rate, avoiding its adverse events.

Tratamiento de la reestenosis coronaria: experiencia con balón liberador de paclitaxel / Treatment of coronary restenosis: experience with paclitaxel eluting balloon

Objetivo: comunicar la experiencia preliminar acerca de la evaluación clínica e invasiva del tratamiento de la reestenosis intrastent convencional con el uso de balón liberador de paclitaxel. Método: se realiza un análisis de tres momentos evolutivos denominados "previo", "índice" y "control" de una serie de casos de reestenosis intrastent (RIS) tratados con balón liberador de paclitaxel (BLP). El evento previo es la situación clínica que motivó el implante de stent convencional (SC) inicial, acerca del cual se hace un análisis clínico-angiográfico retrospectivo. El evento índice, que corresponde a la captación del paciente, es la evolución reestenotica del SC inicial e incluyó un análisis clínico, un estudio angiográfico y la angioplastia con BLP. El evento control incluye el análisis clínico, angiográfico y ultrasonografico al año de seguimiento. Las variables pesquisadas fueron: características basales de la población, presentación clínica, arterias coronarias y sectores involucrados, tipo de RIS, diámetro luminal mínimo (DLM) y área luminal mínima (ALM) por angiografía y adicionalmente por ultrasonografía en el seguimiento. Resultados: se incluyeron ocho pacientes. La edad promedio fue de 57 años. Los cuadros clínicos que determinaron la angioplastia coronaria inicial fueron: cuatro síndromes coronarios agudos con sobreelevación persistente del segmento ST, dos infartos agudos de miocardio de tipo no Q y dos anginas inestables (AI). Los cuadros clínicos en el momento del diagnóstico de RIS y en los cuales se aplicó BLP fueron: tres AI, cuatro IAM no Q y un paciente asintomático con isquemia demostrada por estudio funcional. Las arterias y el sector involucrados fueron: dos arterias descendentes anteriores (ADA) proximal, tres ADA media, una arteria circunfleja media y dos arterias coronarias derechas media. Siete pacientes presentaban RIS difusa y uno focal. En el seguimiento clínico posterior a la aplicación de BLP a los seis, nueve y doce meses se observó una muerte no cardiovascular y una pérdida de seguimiento, el resto estaban asintomáticos. En la angiografía de control al año se comprobó RIS binaria en un solo caso. El análisis por imágenes determinó que en promedio el DLM y el ALM aumentaran dos veces y cuatro veces y media respectivamente entre los eventos “índice” y “control”. La pérdida tardía de DLM o late loss promedio entre el tratamiento con BLP y el control final fue de 0,47 mm. No se comprobó ninguna complicación vinculada al uso de BLP. Conclusión: la utilización de BLP en el tratamiento de la RIS de SC determinó una ganancia de DLM y ALM mantenida al año de seguimiento, no registrándose complicaciones atribuibles al procedimiento.

Objective: clinical, angiographic and intracoronary ultrasound analysis of a series of cases of conventional in-stent restenosis (ISR) treated with paclitaxel eluting balloon (PEB) with 12 months follow up. Method: an analysis of three evolutionary stages called “previous”, “index” and “control” of a series of cases of stent restenosis (ISR) treated with paclitaxel eluting balloon (PEB) is performed. The previous event is the clinical situation which led to the initial bare-metal stent (BMS) implant, on which a retrospective clinical and angiographic analysis is done. The index event, which corresponds to the acquisition of the patient, is the restenotic evolution of the initial BMS and included a clinical analysis, angiography and angioplasty with PEB. The event control includes the clinical, angiographic and ultrasonographic analysis at one year. The researched variables were baseline characteristics of the population, clinical presentation, coronary arteries and sectors involved, the type of ISR, the minimum luminal diameter (MLD) and minimal lumen area (MLA) by angiography and additionally by ultrasonography. Results: 8 patients were included. The mean age was 57 years old. Clinical conditions that led to the initial angioplasty were: 4 acute coronary syndromes with persistent ST-segment elevation, 2 non Q wave acute myocardial infarctions and 2 unstable anginas (UA). The clinical presentations at the time of ISR diagnosis, in which PEB was applied were: 3 UA, 4 non Q wave acute myocardial infarctions and 1 asymptomatic patient with ischemia demonstrated by functional studies. Arteries involved were: 2 proximal anterior descending arteries, 3 mid anterior descending arteries, 1 mid circumflex artery and 2 mid right coronary arteries. 7 patients had diffuse ISR and 1 focal ISR. Clinical follow-up at 6,9 and 12 months after PEB angioplasty observed one not cardiovascular death and one lost at follow-up, the remainings patients were asymptomatics. Angiographic follow up showed ISR in 1 case. The image analysis determined that on average the MLD and MLA increase twice and four and a half times respectively between events “index” and “control”. Average late loss (final reduction in DLM) was 0,47 mm. No complications related to the use of PEB occurred. Conclusion: the use of PEB in the treatment of ISR BMS resulted in a gain of DLM and ALM maintained at one year, recording no complications attributable to the procedure.

Valor de la tomografía de coherencia óptica en el tratamiento guiado de la falla del stent: Presentación de un caso / Value of the optical coherence tomography in the treatment guided of the stent failure: Case report

Desde la llegada de los stents convencionales y farmacoactivos han disminuido considerablemente los eventos de revascularización quirúrgica, sin embargo la trombosis y reestenosis son 2 factores que, aunque han disminuido, permanecen como complicaciones importantes. Existen varios factores que predisponen a la trombosis y a la reestenosis intrastent. La angiografía convencional tiene serias limitaciones para determinar las causas de la falla del stent. La tomografía de coherencia óptica es una técnica sumamente sensible para determinar las causas de trombosis y reestenosis del stent.

Since the advent of bare metal and drug-eluting stents, the surgical revascularization have declined considerably, however the thrombosis and in-stent restenosis are important complications of these devices. There are several factors that predispose to thrombosis and in-stent restenosis. Conventional angiography has serious limitations to determine the causes of stent failure. Optical coherence tomography is a very sensitive technique to determine the cause of thrombosis and in-stent restenosis.