Effect of cashew nut flour on hematological parameters of children living with HIV.

Aim: To assess the effect of cashew nut flour on the hematological parameters of children living with HIV-AIDS. Method: A 32-week randomized, blind clinical trial conducted at a specialized outpatient clinic. Children aged 2-12 years were allocated to intervention groups (IGs) (n = 11) receiving 12 g/day of cashew nut flour and control groups (CGs) (n = 9) receiving 12 g/day of carboxymethyl cellulose. Parameters of erythrocytes, leukocytes, platelets, and lipid profiles were evaluated. Results: In the IG, the elevation and reduction of leukocyte and lipid profile biomarkers, respectively, were not statistically significant (p > 0.05). A clinically and statistically significant increase in mean corpuscular hemoglobin concentration was observed in the CG (p = 0.018), with a large effect size (Cohen's d = 0.9). There were no statistically significant changes in platelet counts among participants (p = 0.18). The effect size for white blood cell count, low-density lipoprotein cholesterol, very low-density lipoprotein, and triglycerides was moderate in the IG compared to the CG. Conclusion: Cashew nut flour supplementation may increase levels of leukocytes and lipid profile parameters in children living with HIV. Brazilian Clinical Trials Registry (REBEC): U1111.1276.6591.

Effect of sevoflurane on serum CK-MB levels after percutaneous coronary stent placement: A prospective randomized clinical trial

OBJECTIVES. Markers of myocardial injury, such as creatine kinase-myocardial band (CK-MB) mass, are elevated in up to 30% of patients undergoing percutaneous coronary intervention (PCI) with stent deployment. This elevation represents myocardial injury that can impact the patient in the long term, including the risk of death. Sevoflurane, an inhaled anesthetic, may have cardioprotective properties that benefit patients undergoing PCI. The primary objective was to compare serum CK-MB mass raise in patients who received sevoflurane to those who received a placebo prior to PCI. METHODS. We enrolled patients with coronary artery disease who were eligible for PCI in a randomized (1:1), double-blind, placebo-controlled trial; patients having experienced acute myocardial infarction within 72 hours and those with saphenous vein graft stenting were excluded. Patients (n = 1254) were randomized to receive sevoflurane (2% inspired fraction) or placebo (oxygen alone) for 30 minutes prior to PCI. Additionally, we compared substantial elevations in CK-MB mass (defined as >5x the upper limit of normal), length of stay in the intensive care unit and in-hospital, and 1-year mortality. RESULTS. Sevoflurane was unable to promote cardioprotection, as determined by CK-MB mass levels (sevoflurane group: 2.52 ± 9.64; control group: 1.84 ± 8.58; P=.32). No effect was noticed on the reduction among patients who (AQ: with?) increase (AQ: increased?) marker levels (prevalence of increase in CK-MB mass greater than the upper limit of normality was 30.8% in the sevoflurane group and 28.9% in the control group; P=.33; 4.6% vs 3.1%, respectively, for increases 5x above the upper limit of normality [P=.21]). CONCLUSIONS. Sevoflurane failed to reduce myocardial injury after PCI. Therefore, its usage should not be routinely recommended.

Effect of sevoflurane on serum CK-MB levels after percutaneous coronary stent placement: A prospective randomized clinical trial.

OBJECTIVES: Markers of myocardial injury, such as creatine kinase-myocardial band (CK-MB) mass, are elevated in up to 30% of patients undergoing percutaneous coronary intervention (PCI) with stent deployment. This elevation represents myocardial injury that can impact the patient in the long term, including the risk of death. Sevoflurane, an inhaled anesthetic, may have cardioprotective properties that benefit patients undergoing PCI. The primary objective was to compare serum CK-MB mass raise in patients who received sevoflurane to those who received a placebo prior to PCI. METHODS: We enrolled patients with coronary artery disease who were eligible for PCI in a randomized (1:1), double-blind, placebo-controlled trial; patients having experienced acute myocardial infarction within 72 hours and those with saphenous vein graft stenting were excluded. Patients (n = 1254) were randomized to receive sevoflurane (2% inspired fraction) or placebo (oxygen alone) for 30 minutes prior to PCI. Additionally, we compared substantial elevations in CK-MB mass (defined as >5x the upper limit of normal), length of stay in the intensive care unit and in-hospital, and 1-year mortality. RESULTS: Sevoflurane was unable to promote cardioprotection, as determined by CK-MB mass levels (sevoflurane group: 2.52 ± 9.64; control group: 1.84 ± 8.58; P=.32). No effect was noticed on the reduction among patients who (AQ: with?) increase (AQ: increased?) marker levels (prevalence of increase in CK-MB mass greater than the upper limit of normality was 30.8% in the sevoflurane group and 28.9% in the control group; P=.33; 4.6% vs 3.1%, respectively, for increases 5x above the upper limit of normality [P=.21]). CONCLUSIONS: Sevoflurane failed to reduce myocardial injury after PCI. Therefore, its usage should not be routinely recommended.

Routine ultrasound-guided femoral access and use of one vascular closure device for femoral hemostasis after TAVR: feasibility and safety

INTRODUCTION: The transfemoral TAVR is a safe and effective treatment for severe and symptomatic aortic stenosis, regardless of the surgical risk profile. The vascular access and hemostasis are fundamental steps of the procedure and have impact on the prognosis. Traditionally, the arterial hemostasis has been obtained through the use of 2 or more vascular closure devices (ProGlide, Perclose) or the association of vascular closure devices (suture + collagen). Nevertheless, the reduction of sheet size and routinary use of ultrasound guided puncture, the use of one vascular closure device could be effective in obtaining hemostasis in such patients. METHODS: Observational, prospective study, including patients submitted to transfemoral TAVR through March/2020 to April/2022. The arterial access was obtained with ultrasound assistance on all cases. From September/2021 we initiated the institutional protocol with the use of one Perclose after obtaining the femoral access (pre-closure technique). We evaluated the need for additional vascular closure devices, the presence of femoral stenosis of > 50% (according to femoral angiography at the end of the procedure) and the occurrence of bleeding (according to the VARC-III criteria). RESULTS: In the period, a total of 75 patients were submitted to transfemoral TAVR on our institution. We used 1 Perclose in 31 patients (Group A) and 2 Perclose devices on 44 patients (Group B). The characteristics of the patients at baseline; mean age of 77 7.32 years, 39% were female, and mean STS score of 3.6%. There were no significant differences between Group A and B. Balloon expandable TAVR was used in 97.3% of the patients, and in 96% of the patients the introducer sheet used was 14F. At the post-procedure femoral angiography, residual stenosis was present in only 1 (4.1%) patient on Group A and on 9 (25%) patients on Group B (p=0.034). there was no difference in major or minor bleeding with manual prolonged compression in both groups. two patients in Group A required additional vascular closure devices and no in group B. CONCLUSION: On this initial series, the ultrasound guided femoral access and the use of one vascular closure device, proved to be feasible and effective on vascular hemostasis, while reducing residual stenosis of the femoral artery when compared to the use of two vascular closure devices.

Parâmetros hematológicos de crianças desnutridas após intervenção nutricional: ensaio clínico randomizado / Parámetros hematológicos de niños desnutridos después de intervención nutricional: ensayo clínico aleatorizado / Hematological parameters of malnourished children after nutritional intervention: a randomized clinical trial

Resumo Objetivo Avaliar parâmetros hematológicos de crianças desnutridas após intervenção nutricional com farinha da castanha de caju. Métodos Ensaio clínico randomizado, controlado, cego. O estudo foi realizado no período de abril a dezembro de 2017, em duas Unidades Básicas de Saúde. A amostra foi composta de crianças menores de 5 anos que preencheram os critérios de inclusão, sendo 15 no Grupo Intervenção (farinha da castanha de caju) e 15 crianças no Grupo Controle (farinha de carboximetilcelulose), alocadas nos grupos de forma randômica aleatória simples. Foram analisados os parâmetros de eritrócitos, hemoglobina e hematócrito (série vermelha) e de leucócitos, neutrófilos, segmentados, eosinófilos, monócitos e linfócitos (série branca). A coleta de sangue foi realizada em dois momentos: o primeiro antes da implementação da intervenção e o segundo após 32 semanas de utilização da farinha da castanha de caju. Para avaliação da normalidade e homogeneidade da amostra, utilizaram-se os testes de Shapiro-Wilk e de variância de Bartlett, respectivamente. Utilizou-se o teste T pareado dentro de cada grupo e, para avaliar possíveis associações entre os Grupos Intervenção e Controle e o nível de leucócitos (abaixo, normal e acima), utilizaram-se o teste exato de Fisher e/ou o teste Fisher-Freeman-Halton. Resultados Houve incremento na média das células individuais da série vermelha do hemograma, sobretudo nos padrões de hemoglobina de crianças desnutridas do Grupo Intervenção (p<0,05). A investigação também apontou diferença intragrupo no parâmetro da hemoglobina, tanto no Grupo Controle (p=0,007) como no Intervenção (p<0,001), bem como no parâmetro hematócrito para ambos os grupos (p=0,001). Especificamente na série branca, após a intervenção, evidenciou-se diminuição significativa nos leucócitos (p=0,04) e linfócitos (p<0,01) Conclusão Após intervenção, a utilização da farinha da castanha de caju melhorou os parâmetros hematológicos das crianças desnutridas. Registro Brasileiro de Ensaios Clínicos (REBEC): U1111.1213.9219

Resumen Objetivo Evaluar parámetros hematológicos de niños desnutridos después de la intervención nutricional con harina da castaña de cajú. Métodos Ensayo clínico aleatorizado, controlado, ciego. El estudio se realizó en el período de abril a diciembre de 2017, en dos Unidades Básicas de Salud. La muestra se compuso por niños menores de 5 años que cumplieron con los criterios de inclusión, 15 en el Grupo Intervención (harina de castaña de cajú) y 15 niños en el Grupo Control (harina de carboximetilcelulosa), repartidas en los grupos de forma muestreo aleatorio simple. Se analizaron los parámetros de eritrocitos, hemoglobina e hematocrito (serie roja) y de leucocitos, neutrófilos, segmentados, eosinófilos, monocitos e linfocitos (serie blanca). La muestra de sangre se realizó en dos momentos: el primero antes de la implementación de la intervención y el segundo después de 32 semanas de utilización de la harina da castaña de cajú. Para la evaluación de la normalidad y la homogeneidad de la amuestra, se utilizaron los tests de Shapiro-Wilk y de varianza de Bartlett, respectivamente. Se utilizó la prueba T pareada dentro de cada grupo y, para evaluar posibles asociaciones entre los Grupos Intervención y Control y el nivel de leucocitos (debajo, normal y superior), se utilizó la prueba exacta de Fisher o prueba de Fisher-Freeman-Halton. Resultados Hubo un aumento en el promedio de las células individuales de la serie roja del hemograma, sobre todo en los estándares de hemoglobina de niños desnutridos del Grupo Intervención (p<0,05). La investigación también apuntó una diferencia intragrupo en el parámetro de la hemoglobina, tanto en el Grupo Control (p=0,007) como en la Intervención (p<0,001), así como en el parámetro hematocrito para ambos grupos (p=0,001). Específicamente en la serie blanca, después de la intervención, se evidenció una disminución significativa en los leucocitos (p=0,04) y linfocitos (p<0,01) Conclusión Después de la intervención, la utilización de la harina de la castaña de cajú mejoró los parámetros hematológicos de los niños desnutridos.

Abstract Objective To assess hematological parameters of malnourished children after nutritional intervention with cashew nut flour. Methods This is a randomized, controlled, blind trial. The study was conducted from April to December 2017, in two Basic Health Units. The sample consisted of children under 5 years of age who met the inclusion criteria, 15 in the Intervention Group (cashew nut flour) and 15 children in the Control Group (carboxymethylcellulose flour), randomly allocated to the groups. The parameters of erythrocytes, hemoglobin and hematocrit (red blood cells) and leukocytes, neutrophils, segmented, eosinophils, monocytes and lymphocytes (white blood cells) parameters were analyzed. Blood collection was performed in two moments: the first before intervention implementation and the second after 32 weeks of use of cashew nut flour. To assess the sample normality and homogeneity, Shapiro-Wilk and Bartlett variance tests were used, respectively. The paired t-test was used within each group and, to assess possible associations between the Intervention and Control Groups and the level of leukocytes (below, normal and above), Fisher's Exact test and/or Fisher-Freeman-Halton test were used. Results There was an increase in the mean of the individual red blood cell count, especially in the hemoglobin patterns of malnourished children in the Intervention Group (p<0.05). The investigation also showed an intragroup difference in the hemoglobin parameter, both in the Control Group (p=0.007) and in the Intervention (p<0.001) as well as in the hematocrit parameter for both groups (p=0.001). Specifically in the white blood cells, after intervention, there was a significant decrease in leukocytes (p=0.04) and lymphocytes (p<0.01) Conclusion After intervention, the use of cashew nut flour improved the hematological parameters of malnourished children. Brazilian Clinical Trial Registry (REBEC): U1111.1213.9219

Patients with COVID-19 who experience a myocardial infarction have complex coronary morphology and high in-hospital mortality: Primary results of a nationwide angiographic study.

OBJECTIVES: We aimed to explore angiographic patterns and in-hospital outcomes of patients with concomitant coronavirus disease-19 (COVID-19) and myocardial infarction (MI). BACKGROUND: Patients with COVID-19 may experience MI during the course of the viral infection. However, this association is currently poorly understood. METHODS: This is a multicenter prospective study of consecutive patients with concomitant COVID-19 and MI who underwent coronary angiography. Quantitative and qualitative coronary angiography were analyzed by two observers in an independent core lab. RESULTS: A total of 152 patients were included, of whom 142 (93.4%) had COVID-19 diagnosis confirmation. The median time between symptom onset and hospital admission was 5 (1-10) days. A total of 83 (54.6%) patients presented with ST-elevation MI. The median angiographic Syntax score was 16 (9.0-25.3) and 69.0% had multi-vessel disease. At least one complex lesion was found in 73.0% of patients, 51.3% had a thrombus containing lesion, and 57.9% had myocardial blush grades 0/1. The overall in-hospital mortality was 23.7%. ST-segment elevation MI presentation and baseline myocardial blush grades 0 or 1 were independently associated with a higher risk of death (HR 2.75, 95%CI 1.30-5.80 and HR 3.73, 95%CI 1.61-8.61, respectively). CONCLUSIONS: Patients who have a MI in the context of ongoing COVID-19 mostly present complex coronary morphologies, implying a background of prior atherosclerotic disease superimposed on a thrombotic milieu. The in-hospital prognosis is poor with a markedly high mortality, prompting further investigation to better clarify this newly described condition.

Effects of Cashew Nut (Anacardium occidentale L.) Seed Flour in Moderately Malnourished Children: Randomized Clinical Trial.

The monitoring and combined use of dietary supplements to restore adequate growth are paramount and highly recommended in child malnutrition, an important public health problem. The objective of this study was to analyze the effects of cashew nut seed flour in children with moderate malnutrition, treated at primary healthcare services. This is a randomized clinical trial conducted from April to October 2017 in the city of Imperatriz, Brazil. The sample comprised 30 children born at term, aged between 2 and 5 years, and newly diagnosed with malnutrition (60 days or less), randomized into experimental and control groups. The intervention consisted of daily intake of cashew nut seed flour. There was intragroup statistically significant difference in the glucose levels of children who were assigned to the control group (p=0.02) and in the glycated hemoglobin in the experimental group (p < 0.01). Intergroup analysis of glycated hemoglobin levels showed statistically significant differences in favor of the experimental group (p=0.01). HDL and LDL had, respectively, increased and decreased in the experimental group. The use of cashew nut seed flour in a 24-week period had positive effects on glycated hemoglobin, HDL, and LDL parameters in moderately malnourished children.

Long-Term Follow-Up of Patients after Percutaneous Coronary Intervention with Everolimus-Eluting Bioresorbable Vascular Scaffold.

BACKGROUND:: Bioresorbable vascular scaffolds (BVS) were developed to improve the long-term results of percutaneous coronary intervention, restoring vasomotion. OBJECTIVES:: To report very late follow-up of everolimus-eluting Absorb BVS (Abbott Vascular, Santa Clara, USA) in our center. METHODS:: Observational retrospective study, in a single Brazilian center, from August 2011 to October 2013, including 49 patients submitted to Absorb BVS implantation. Safety and efficacy outcomes were analyzed in the in-hospital and very late follow-up phases (> 2 years). RESULTS:: All 49 patients underwent a minimum follow-up of 2.5 years and a maximum of 4.6 years. Mean age was 56.8 ± 7.6 years, 71.4% of the patients were men, and 26.5% were diabetic. Regarding clinical presentation, the majority (94%) had stable angina or silent ischemia. Device success was achieved in 100% of cases with 96% overall procedure success rate. Major adverse cardiovascular events rate was 4% at 30 days, 8.2% at 1 year, and 12.2% at 2 years, and there were no more events until 4.6 years. There were 2 cases of thrombosis (1 subacute and 1 late). CONCLUSIONS:: In this preliminary analysis, Absorb BVS showed to be a safe and effective device in the very late follow-up. Establishing the efficacy and safety profiles of these devices in more complex scenarios is necessary. FUNDAMENTO:: Os suportes vasculares bioabsorvíveis (SVB) foram desenvolvidos com o intuito de melhorar os resultados da intervenção coronária percutânea a longo prazo, restabelecendo-se a vasomotricidade. OBJETIVOS:: Reportar o seguimento muito tardio do implante do SVB eluidor de everolimus Absorb® (Abbot Vascular, Santa Clara, EUA) em nosso centro. MÉTODOS:: Estudo observacional, retrospectivo, em um único centro brasileiro, que incluiu 49 pacientes submetidos ao implante do SVB Absorb® entre agosto/2011 e outubro/2013. Foram analisados os desfechos de segurança e eficácia na fase hospitalar e bastante tardia (> 2 anos). RESULTADOS:: Todos os 49 pacientes completaram um seguimento mínimo de 2,5 anos, sendo o máximo de 4,6 anos. A média de idade foi 56,8 ± 7,6 anos, sendo 71,4% da população estudada do sexo masculino e 26,5% composta por diabéticos. Considerando a apresentação clínica, a grande maioria (94%) tinha angina estável ou isquemia silenciosa. Obteve-se sucesso do dispositivo em 100% dos casos e do procedimento, em 96%. A taxa de eventos cardiovasculares maiores foi de 4% aos 30 dias, de 8,2% em 1 ano, e de 12,2% em 2 anos, sem mais eventos até 4,6 anos. Houve 2 casos de trombose (1 subaguda e 1 tardia) até o último seguimento. CONCLUSÕES:: Nesta análise preliminar, o uso do SVB Absorb® mostrou-se seguro e eficaz no seguimento bastante tardio. Faz-se necessário estabelecer o perfil de eficácia e segurança destes dispositivos em cenários de maior complexidade.

Evaluation of the Safety and Efficacy of the Novel Svelte Acrobat Integrated Delivery System via Radial Approach With 5 Fr Catheters.

PURPOSE: To evaluate the safety and efficacy of the Svelte Acrobat integrated delivery system (IDS) via radial approach with 5 Fr catheters. The direct stenting (DS) system enables easy delivery, deployment, and postdilatation of a cobalt-chromium stent. METHODS: Patients with coronary artery disease (CAD) were prospectively enrolled at three centers to undergo percutaneous coronary intervention with DS via radial approach using 5 Fr catheters. The primary endpoint was IDS success, which was defined as DS without postdilatation and final stenosis <20% with Thrombolysis in Myocardial Infarction (TIMI)-3 flow. RESULTS: Fifty consecutive patients with 55 lesions were included. The procedure success rate was 98%. The device could not cross the lesion in 2 cases, so DS success was 96%. Fifty lesions met the primary study objective; thus, IDS success rate was 91%. The procedure duration was 21 ± 9 minutes, fluoroscopy time was 7.3 ± 4.7 minutes, and contrast volume per vessel was 103 ± 33 cm3. The final residual stenosis, by quantitative coronary angiography, was 3.4 ± 4%. The reduced need for additional catheters resulted in a 20% procedural cost reduction. There were no bleeding or vascular complications. At 8 months, the event-free survival rate was 84%. CONCLUSIONS: DS using the Svelte Acrobat IDS via radial approach with low-profile catheters is safe and efficacious in select coronary artery disease patients, and its use is associated with potential procedural cost savings.

A volumetric intravascular ultrasound comparison of early drug-eluting stent thrombosis versus restenosis.

OBJECTIVES: We compared intravascular ultrasound findings of drug-eluting stent (DES)-treated lesions that developed thrombosis versus in-stent restenosis (ISR). BACKGROUND: Stent underexpansion is a predictor of both DES thrombosis and ISR. However, all underexpanded DES may not be equal. METHODS: Intravascular ultrasound findings from 20 definite DES thrombosis patients (representing all definite thromboses from 1,407 consecutive DES patients undergoing intravascular ultrasound imaging) were compared with 50 risk-factor-balanced ISR patients with no evidence of stent thrombosis and 50 risk-factor-balanced "no-event" patients with neither thrombosis nor ISR. RESULTS: Minimum stent area (3.9 +/- 1.0 mm(2) vs. 5.0 +/- 1.7 mm(2), p = 0.008), mean stent area (5.3 +/- 1.0 mm(2) vs. 7.2 +/- 2.0 mm(2), p = 0.001), and both focal (55.4 +/- 13.2% vs. 74.9 +/- 19.9%, p < 0.001) and diffuse stent expansion (77.4 +/- 19.3% vs. 109.5 +/- 23.1%, p < 0.001) were significantly smaller in the stent thrombosis group versus ISR and in both groups versus the "no-event" group. Minimum stent area <4.0 mm(2) (65% vs. 32%, p = 0.01) or <5.0 mm(2) (85% vs. 52%, p = 0.01) was more common in the stent thrombosis versus the ISR group and in both groups vs. "no-event" patients; and the relative length of the stent area <5 mm(2) was greatest in the stent thrombosis group (36.6 +/- 37.7%), intermediate in the ISR group (22.8 +/- 35.6%), and least in the "no-event" group (10.9 +/- 26.4%), p = 0.04. In the stent thrombosis group, the minimum stent area site occurred in the proximal stent segment in 50% versus 24% in the ISR group (p = 0.03). There were no differences in edge dissection, stent fracture, or stent-vessel-wall malapposition among the groups. CONCLUSIONS: The DES-treated lesions that develop thrombosis or restenosis are often underexpanded, but underexpansion associated with thrombosis is more severe, diffuse, and proximal in location.

Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions.

BACKGROUND: Despite the advances in interventional cardiology, stent expansion remains an important predictor of success, impacting restenosis and thrombosis rates after either bare-metal (BMS) or drug-eluting stent implantation. Especially for the treatment of complex lesions (e.g., calcified lesions, in-stent restenosis, etc.), adequate lesion preparation might help improve procedural results as well as clinical outcomes. We sought to investigate the safety, feasibility and mechanism of action of a new scoring-balloon catheter, the AngioSculpt, comprised of a semicompliant balloon and a nitinol spiral cage designed to address complex lesions. METHODS: A total of 60 consecutive patients at two centers were prospectively enrolled in this first-in-man coronary study and divided into two groups according to the type of lesion treated: Group I: patients with de novo coronary lesions (n = 47) as a pretreatment strategy before BMS implantation, and Group II: patients with BMS restenosis (n = 17) as a standalone therapy. A subgroup of patients in each cohort was assigned to intravascular (IVUS) analysis. Patients in Group II were submitted to routine 6-month follow-up angiography. In Group I, angiographic restudy was contingent upon the presence of ischemia. Lesions longer than 20 mm in very tortuous vessels, in arterial or vein grafts, in the setting of acute myocardial infarction or with visible thrombus were excluded from this study. RESULTS: Success was achieved in all cases. The mean age of the study populations was 62 +/- 11.6 years (Group I) and 53 +/- 9.4 years (Group II), with 26% and 18% diabetics, respectively. In Group I, 73% of lesions were diffuse and fibrocalcified, while in Group II, 72% were classified as diffuse. No serious complications were observed in either group. Balloon slippage (or the "watermelon seed" phenomenon) was not observed. Significant acute gain was achieved in both groups (0.7 mm in Group I and 1.64 mm in Group II). A minimum final area (in-stent) 6.5 mm2 was achieved in 85% of the cases in Group I and in 82% of the cases in Group II. CONCLUSIONS: In this preliminary in vivo study, the use AngioSculpt(R) proved to be feasible and safe for the treatment of complex coronary lesions. Six-month results suggest the use of this novel device as an attractive option for the percutaneous approach of restenotic coronary lesions and should be assessed in a larger, more complex cohort of patients.

Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels

Background Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (N3.0 mm)

has yet to be established. Objective We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. Methods This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat

intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of z3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to

250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. Results Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single

vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 F 0.3 mm for BMS vs 3.18 F 0.2 for DES; P = .1).

Lesion was significantly longer in the group treated with DES (13.4 F 5.1 mm for BMS group vs 14.3 F 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS

were free of major events ( P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). Conclusion Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type

Reestenose associada à fratura de stent com liberação de sirolimus / Stent Fracture Associated to Restenosis in Sirolimus Eluting Sten

Os autores descrevem um caso de fratura de stent Cypher®. Inicialmente, a fratura foi acompanhada clinicamente (paciente era assintomático, sem evidência clara de isquemia à investigação não-invasiva). Entretanto, durante seguimento tardio, o paciente passou a apresentar sintomas de angina estável, necessitando de nova intervenção percutânea e, posteriormente, implante de novo stent farmacológico.

The authors describe a case of stent fracture following the use of Cypher®. Initially, the fracture was clinically approached (patient was asymptomatic with no clear evidence of ischemia in non-invasive assessment). However, during the long-term follow-up this patient started manifesting stable angina symptoms requiring new percutaneous intervention with additional drug-eluting stent implantation.

Clinical and angiographic results of percutaneous coronary revascularization using a trilayer stainless steel-tantalum-stainless steel phosphorylcholine-coated stent: the TriMaxx trial.

BACKGROUND: The TriMaxx coronary stent system includes a novel trilayer metal stent having two outer layers of 316L stainless steel and with an inner 0.0007 inches layer of tantalum. This enables creation of a maximally flexible and thin device (0.0029 inches) while still maintaining the requisite strength and radiopacity for effective implantation. OBJECTIVES: The objective of this multi-center, single-arm prospective clinical trial was to assess the safety and performance of the TriMaxx stent for the treatment of single de novo coronary artery lesions. METHODS: One hundred patients with ischemic coronary occlusive disease because of single de novo obstructive lesions of native coronary arteries were treated with 3 x 15 or 3 x 18 mm TriMaxx stents in four hospitals in Brazil and Germany between May of 2004 and September of 2005. An independent core laboratory analyzed the quantitative coronary angiography (QCA) results immediately after stent implantation, and after six months. RESULTS: The lesion, procedure, and device-deployment success rates were 100, 99, and 100%, respectively. Eighty-eight patients underwent follow-up angiography at 6 +/- 1 months. After six months, 13 (13%) of patients had sustained major adverse cardiac events, including 9.0% that required target lesion revascularization (TLR). The follow-up angiographic studies revealed a binary in-stent restenosis rate of 25% with in-stent late lumen loss of 0.94 +/- 0.57 mm. CONCLUSIONS: These results demonstrate that the TriMaxx stent can be safely deployed for the treatment of single de novo coronary occlusive lesions with six-month clinical and angiographic results rates comparable to historical results using other bare metal stents.

Treatment of restenotic drug-eluting stents: an intravascular ultrasound analysis.

BACKGROUND: The intravascular ultrasound (IVUS) findings during repeat intervention for drug-eluting stent (DES) restenosis have not been well described. METHODS: We identified 62 consecutive DES restenosis lesions (45 sirolimus-eluting stents and 17 paclitaxel-eluting stents) undergoing repeat intervention with pre and postintervention IVUS. Lumen, stent and intimal hyperplasia (stent minus lumen) areas were measured at the minimal lumen area (MLA) site and minimal stent area (MSA) site. RESULTS: Repeat stent implantation was performed in 55 lesions (88.7%). Overall, MLA increased from 2.3 +/- 0.7 mm(2) preintervention to 4.6 +/- 1.6 mm(2) postintervention. Preintervention MLA was seen at exactly the preintervention MSA site in 42%, while 73% of postintervention MLAs were located at the preintervention MSA site. There was a strong correlation between the preintervention MSA and the postintervention MLA (r = 0.79; p < 0.001). Preintervention MSA was the strongest independent predictor of a larger postintervention MLA (coefficient 0.72; p < 0.001). CONCLUSIONS: The preintervention MSA was a major predictor of larger lumen area after repeat intervention for DES restenosis. Several IVUS studies have shown that stent dimensions do not change over time. Therefore, the MSA of the original stent implantation procedure still has the greatest impact on subsequent interventions to treat DES restenosis.

Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels

BACKGROUND: Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (> 3.0 mm) has yet to be established. OBJECTIVE: We investigated whether DES are superior to bare metal stents (BMS) in terms of clinical outcomes for the treatment of large coronary vessels. METHODS: This study assessed the long-term outcomes (cardiac death, acute myocardial infarction, and need for repeat intervention in the treated vessel) of patients treated with either a DES (Cypher and Taxus) or a BMS of > or = 3.5 mm in diameter. A total of 250 consecutive patients who underwent DES implantation were clinically followed for 1 year and compared to 250 patients who were treated with BMS. Interventions in the setting of acute ST elevation myocardial infarction and treatment of bypass grafts were excluded. RESULTS: Cypher was the DES deployed in 70.8% of cases. Most of the enrolled patients were men (78%) with single vessel disease (65.6%). The left anterior descending artery was the culprit vessel in 34.2% of cases. Bare metal stent and DES cohorts had equivalent interpolated reference vessel diameter (3.19 +/- 0.3 mm for BMS vs 3.18 +/- 0.2 for DES; P = .1). Lesion was significantly longer in the group treated with DES (13.4 +/- 5.1 mm for BMS group vs 14.3 +/- 3.5 for DES; P = .0018). After 1 year of clinical follow-up, 95.2% of patients treated with DES and 91.2% of the patients who received BMS were free of major events (P = .2). A trend toward higher target-lesion revascularization was noticed in the group treated with BMS (4.8% vs 1.6%; P = .07). CONCLUSION: Percutaneous treatment of large coronary vessels carries a low risk of clinical events irrespective of the type of stent used.

A three-dimensional intravascular ultrasound comparison between the new zotarolimus-eluting stent (ZoMaxx) and the non-drug-eluting TriMaxx stent.

BACKGROUND: Despite the effectiveness of sirolimus- and paclitaxel-eluting stents in reducing intimal hyperplasia (IH) and the need for repeat revascularization, concerns about their long-term safety have motivated the search for new drug-eluting stents (DES). Recently developed, the ZoMaxx stent combines a sirolimus-analogous agent (zotarolimus), featuring a phosphorycoline polymer and stainless steel and tantalum platform. We sought to assess the efficacy of this new DES in reducing IH. METHODS: A total of 40 patients were treated with the ZoMaxx stent and compared to 50 patients treated with its non-drug-eluting equivalent, the TriMaxx stent. Only single de novo lesions in native coronary vessels greater than or equal to 3.0 mm were enrolled. Serial quantitative coronary angiography and intravascular ultrasound (IVUS) images were obtained at baseline and 6- month follow up. All patients were clinically followed for 1 year. This analysis aimed to compare the percent of IH between the 2 stents. Secondarily, we assessed in-segment late loss, binary restenosis and major adverse cardiac events. RESULTS: Baseline patient and lesion characteristics were comparable between the 2 groups. At follow up, zotarolimus efficiently suppressed neointimal hyperplasia formation with a marked reduction in the percentage of stent obstruction by IVUS (4.6 +/- 3.6% vs. 31.2 +/- 16%; p < 0.0001). Almost 90% of the segments stented with ZoMaxx did not exhibit more than 10% of obstruction. After 1 year, 12 patients treated with the TriMaxx and 2 patients treated with the ZoMaxx presented in-segment binary restenosis (p = 0.03). CONCLUSIONS: In this initial experience, ZoMaxx proved to be clinically safe and superior to its non-drug-coated equivalent in reducing in-stent IH formation and restenosis.

Inibição da proliferação neointimal após o implante de stents eluidores de biolimus A9: Análise volumétrica tardia com ultra-som intracoronário / Supressiion of intimal proliferation after implantation of biolimus A9-eluting stents: 6-month single-center intravascular ultrasound follow-up

Introdução: O estudo STEALTH I demonstrou a eficácia e segurança dos stents eluidores de Biolimus A (BA9) em reduzir a perda-tardia angiográfica e apresentar uma baixa incidência de eventos cardíacos maiores, entretanto os achados de ultra-som intracoronário (USIC) ainda não foram descritos. O objetivo deste estudo é descrever os achados de análise volumétrica por USIC nos pacientes recrutados em nossa instituição. Métodos e Resultados: Quarenta e cinco pacientes apresentando lesão coronária de novo, única, foram randomizados 2:1 para receber stents eluidores de BA9 (n igual 30) ou stents controle (n igual 15). A média de idade foi de 58 anos, com 16 por cento diabéticos e 62 por cento do sexo masculino. As características clínicas e angiográficas foram similares entre os grupos. Aos 6 meses de seguimento não houve diferença significativa entre os grupos quanto a desfechos clínicos. O índice de hiperplasia intimal intra-stent foi inferior no grupo dos stents eluidores de BA9 em comparação ao grupo controle 0,19 mais/menos 0,08 vs. 2.71 mais/menos 0.50, ) menor 0.0001), assim como o percentual de obstrução...

Background: Biolimus A9 (BA9) is a novel sirolimus analog with similar antiproliferative properties. BA9-eluting stents reduce angiographic late-loss compared to bare metal stents (BMS), with a low incidence of major adverse cardiac events (MACE), as reported in the randomized, controlled STEALTH I trial. We describe the intravascular ultrasound (IVUS) volumetric findings of patients enrolled at our institution. Methods and Results: Forty-five patients presenting a single, de novo coronary lesion (2.5-4.0 mm vessels; lesion length <24 mm) were randomly assigned in a 2:1 basis to receive either BA9-eluting (n=30) or bare metal stents (n=15). Mean age was 58 years, with 16% diabetics and 62% men. Baseline clinical and angiographic characteristics were similar between groups. At 6 month follow-up, there was no statistical difference in clinical outcomes between groups. In-stent intimal hyperplasia index measured by IVUS was 0.19+/-0.08 mm3/ mm3 for the BA9 group vs. 2.71+/-0.50 mm3/mm3 for BMS controls. The percentage of stent obstruction was also significantly lower for the BA9 group when compared to BMS (2.2+/-0.80% vs. 19.9+/-4.67%, P<0.0001). No stent thrombosis, aneurysm formation or incomplete stent apposition was observed in any group. Conclusions: Using IVUS volumetric analysis, we showed that BA9-eluting stents have a potent inhibitory effect on neointimal proliferation when compared to BMS at 6-month follow-up.

Late incomplete apposition after drug-eluting stent implantation: incidence and potential for adverse clinical outcomes

Aim Late acquired incomplete stent apposition (ISA) has been documented after drug-eluting stent (DES) implantation; However, its clinical consequences of late ISA after implantation sirolimus - (SES) or paclitaxel-eluting stent (PES) in a non-elected population. Methods and Results From our database, we analysed 195 consecutive patients who underwent DES placetement(175 with SES and 20 with PES) into native artery lesions and had serial intravascular ultrasound studies (IVUS) performed at index procedure and after 6-8 months. They were clinically followed for 29 +- 15 mounths (median of 24.3 months, interquartile range 18.1 - 31.6 months. They were clinically followed for a separation of at least one stent strut from the vessel wall in a segment without a side-branch and where the immediate post-implantation IVUS revealed complete apposition of stent struts...

Late incomplete apposition after drug-eluting stent implantation: incidence and potential for adverse clinical outcomes.

AIM: Late-acquired incomplete stent apposition (ISA) has been documented after drug-eluting stent (DES) implantation; however, its clinical role remains controversial. We sought to investigate the incidence and long-term clinical consequences of late ISA after implantation of sirolimus- (SES) or paclitaxel-eluting stent (PES) in a non-selected population. METHODS AND RESULTS: From our database, we analysed 195 consecutive patients who underwent DES placement (175 with SES and 20 with PES) into native artery lesions and had serial intravascular ultrasound studies (IVUS) performed at index procedure and after 6-8 months. They were clinically followed for 29 +/- 15 months (median of 24.3 months, interquartile range 18.1-31.6 months). Late ISA was defined as separation of at least one stent strut from the vessel wall in a segment without a side-branch and where the immediate post-implantation IVUS revealed complete apposition of stent struts. We identified 10 patients (5.1%) with late ISA, three patients after PES, and seven patients after SES implantation. ISA was localized almost exclusively at body of the stents (nine out of 10 cases). Mean ISA volume and length were 44.5 +/- 41.9 mm(3) and 7.4 +/- 11 mm, respectively. There was a marked increase in vessel volume from 416.0 +/- 163.9 mm(3) at baseline to 514.4 +/- 247.9 mm(3) at follow-up (P = 0.001) with no significant change in plaque volume (232.4 +/- 52.7 at baseline and 226.4 +/- 22.3 mm(3) at follow-up, P = 0.3) in patients who presented with late-acquired ISA. During the follow-up period, one patient with SES and one patient with PES who presented late-acquired ISA had late stent thrombosis and acute myocardial infarction. CONCLUSION: Late-acquired ISA was observed in 5.1% of patients after DES implantation and is related to regional vessel positive remodelling. The relationship between late-acquired ISA and long-term adverse outcomes (e.g. stent thrombosis) requires further analysis.