Fundamentos: Ensaios prévios reunindo pacientes em series consecutivas ou randomicas sem cegamento evidenciaram beneficio da adição do cilostozol à terapia antiplaquetária em diabéticos submetidos ao implante de stents coronários farmacológicos com redução nas taxas de reestenose binária, perda tardia intra-stent e revascularização tardia da lesão alvo. Objetivos: O objetivo primário deste estudo foi verificar se a adição do cilostazol à dupla terapia antiplaquetária, proporcionaria uma redução adicional da hiperplasia intimal em diabéticos após o implante de stent farmacológico, mensurada por meio do cálculo do volume de obstrução pelo ultrassom intracoronário 9 meses após o procedimento índice. Os objetivos secundários foram aferir a angiografia quantitativa do vaso alvo e ocorrência de eventos cardíacos adversos graves (óbito, infarto do miocárdio não fatal e necessidade de nova revascularização da lesão-alvo) aos 30 dias, 9 meses e 1 ano. Casuística e métodos: Estudo prospectivo, unicêntrico, randomizado, duplo cego, reunindo 133 pacientes diabéticos, comparando pacientes que receberam cilostazol (Grupo 1, n= 65 ) versus placebo (Grupo 2, n= 68), submetidos a implante de stent coronário com liberação de zotarolimus em artéria coronária nativa com estenose maior ou igual a 50% e diâmetro de referência igual ou superior a 2,0 mm (avaliação visual), com reestudo angiográfico e análise ultrassonográfica aos 9 meses. Resultados: Os 2 grupos foram similares nas características clínicas, angiográficas e técnicas, exceto na evidencia de maior incidência de hipertensão arterial no grupo 2 (81,5% vs 94,1%, p=0,026) assim como nos diâmetros dos stents coronários utilizados, significativamente menores no grupo 1 (2,78 mm vs 2,96 mm, p<0,001). O calculo do volume de obstrução intimal por meio do ultrassom intracoronário aos 9 meses foi similar entre os grupos (33,2% vs 35,1%, p=0,069), assim como as taxas de eventos cardíacos adversos graves (12,3% vs 8,8%, p= 0,811), trombose de stent (1,5% versus 0,75%, p= 0,237), reestenose binária intra-sent (9,8% vs 6,8%, p= 0,988), perda tardia intra-stent (0,60 vs 0,64, p=0,300) e no segmento ( 0,57 vs 0,58, p= 0,387). Conclusões: A adição do cilostazol à dupla terapia antiplaquetária com ácido acetilsalicílico e clopidogrel em pacientes diabéticos submetidos à implante de stent com zotarolimus, não reduziu eventos cardíacos adversos graves ou o porcentual de hiperplasia intimal intra-stent mensurado pela análise volumétrica do ultrassom intracoronário. / Background: Previous trials with assembled patients in consecutive or random series without blindness offered evidence of the benefit adding cilostazol to the antiplatelet therapy in diabetic patients undergoing drug-eluting stents coronary implantation, with reduction in binary restenosis rates, in-stent late loss and late target lesion revascularization. Objectives: The primary objective of this study was to determine whether the addition of cilostazol to the dual antiplatelet therapy would provide an additional intimal hyperplasia reduction in diabetic patients after drug-eluting stents implantation, measured by calculating the obstruction volume through the intravascular ultrasound 9 months after the index procedure. Secondary objectives were to assess the target vessel quantitative angiography and the occurrence of serious adverse cardiac events (death, nonfatal myocardial infarction and need for a target lesion revascularization) at 30 days, 9 months and 1 year. Methods: Prospective, single center, randomized, double blinded study, gathering 133 diabetic patients, comparing who received cilostazol (Group 1, n= 65) versus placebo (Group 2, n= 68), undergoing coronary stenting, with the releasing of zotarolimus in a native coronary artery with stenosis greater than or equal to 50% and reference diameter equal to or greater than 2.0 mm (visual assessment) with the intravascularultrasound and angiographic restudy at 9 months. Results: Both groups were similar in clinical, angiographic and technical characteristics, except for a higher incidence of arterial hypertension in group 2 (81,5% vs 94,1%, p=0,026) as well as significantly lower coronary stents diameters in group 1 (2,78 mm vs 2,96 mm, p<0,001). The intimal obstruction volume calculated by the intravascularultrasound at 9 months was similar between the groups (33,2% vs 35,1%, p=0,069), as well as the rates of major adverse cardiac events (12,3% vs 8,8%, p= 0,811), stent thrombosis (1,5% versus 0,75%, p= 0,237), in-stent binary restenosis (9,8% vs 6,8%, p= 0,988), in stent late loss (0,60 vs 0,64, p=0,300) and at the segment ( 0,57 vs 0,58, p= 0,387). Conclusions: The addition of cilostazol to the dual antiplatelet therapy with acetylsalicylate acid and clopidogrel, in diabetic patients undergoing stent implantation with zotarolimus did not reduce major adverse cardiac events nor the percentage of intra-stent intimal hyperplasia measured by the intravascularultrasound volumetric analysis.

Stenting remains a common treatment option for atherosclerotic arteries. The main drawback of early stent platforms was restenosis, which has been combated by drug eluting stents; however, these stents have suffered from a higher incidence of late stage thrombosis. To address current stenting limitations, the major research focuses have been the development of the next generation of drug eluting stents and first generation bioabsorbable stents. The main objective of this dissertation was the design and development of a new class of bioabsorbable stent composed of elastin mimetic protein polymers. The first phase explored different stent design schemes and fabrication strategies. Successfully fabricated stents were then mechanically tested to ensure they possessed sufficient mechanical strength. Additionally, described herein is the potential to modulate the properties of the elastin mimetics through different crosslinking strategies. We have demonstrated that chemical crosslinking allows for the tailoring of the physical, mechanical, drug delivery, and endothelialization properties of these materials. The potential for drug delivery from this elastin mimetic stent was benchmarked as was the potential to endothelialize these stents. Furthermore, we developed the necessary delivery systems to allow for deployment in the rat aorta model.

Fundamentos: Ensaios prévios reunindo pacientes em series consecutivas ou randomicas sem cegamento evidenciaram beneficio da adição do cilostozol à terapia antiplaquetária em diabéticos submetidos ao implante de stents coronários farmacológicos com redução nas taxas de reestenose binária, perda tardia intra-stent e revascularização tardia da lesão alvo. Objetivos: O objetivo primário deste estudo foi verificar se a adição do cilostazol à dupla terapia antiplaquetária, proporcionaria uma redução adicional da hiperplasia intimal em diabéticos após o implante de stent farmacológico, mensurada por meio do cálculo do volume de obstrução pelo ultrassom intracoronário 9 meses após o procedimento índice. Os objetivos secundários foram aferir a angiografia quantitativa do vaso alvo e ocorrência de eventos cardíacos adversos graves (óbito, infarto do miocárdio não fatal e necessidade de nova revascularização da lesão-alvo) aos 30 dias, 9 meses e 1 ano. Casuística e métodos: Estudo prospectivo, unicêntrico, randomizado, duplo cego, reunindo 133 pacientes diabéticos, comparando pacientes que receberam cilostazol (Grupo 1, n= 65 ) versus placebo (Grupo 2, n= 68), submetidos a implante de stent coronário com liberação de zotarolimus em artéria coronária nativa com estenose maior ou igual a 50% e diâmetro de referência igual ou superior a 2,0 mm (avaliação visual), com reestudo angiográfico e análise ultrassonográfica aos 9 meses. Resultados: Os 2 grupos foram similares nas características clínicas, angiográficas e técnicas, exceto na evidencia de maior incidência de hipertensão arterial no grupo 2 (81,5% vs 94,1%, p=0,026) assim como nos diâmetros dos stents coronários utilizados, significativamente menores no grupo 1 (2,78 mm vs 2,96 mm, p<0,001). O calculo do volume de obstrução intimal por meio do ultrassom intracoronário aos 9 meses foi similar entre os grupos (33,2% vs 35,1%, p=0,069), assim como as taxas de eventos cardíacos adversos graves (12,3% vs 8,8%, p= 0,811), trombose de stent (1,5% versus 0,75%, p= 0,237), reestenose binária intra-sent (9,8% vs 6,8%, p= 0,988), perda tardia intra-stent (0,60 vs 0,64, p=0,300) e no segmento ( 0,57 vs 0,58, p= 0,387). Conclusões: A adição do cilostazol à dupla terapia antiplaquetária com ácido acetilsalicílico e clopidogrel em pacientes diabéticos submetidos à implante de stent com zotarolimus, não reduziu eventos cardíacos adversos graves ou o porcentual de hiperplasia intimal intra-stent mensurado pela análise volumétrica do ultrassom intracoronário. / Background: Previous trials with assembled patients in consecutive or random series without blindness offered evidence of the benefit adding cilostazol to the antiplatelet therapy in diabetic patients undergoing drug-eluting stents coronary implantation, with reduction in binary restenosis rates, in-stent late loss and late target lesion revascularization. Objectives: The primary objective of this study was to determine whether the addition of cilostazol to the dual antiplatelet therapy would provide an additional intimal hyperplasia reduction in diabetic patients after drug-eluting stents implantation, measured by calculating the obstruction volume through the intravascular ultrasound 9 months after the index procedure. Secondary objectives were to assess the target vessel quantitative angiography and the occurrence of serious adverse cardiac events (death, nonfatal myocardial infarction and need for a target lesion revascularization) at 30 days, 9 months and 1 year. Methods: Prospective, single center, randomized, double blinded study, gathering 133 diabetic patients, comparing who received cilostazol (Group 1, n= 65) versus placebo (Group 2, n= 68), undergoing coronary stenting, with the releasing of zotarolimus in a native coronary artery with stenosis greater than or equal to 50% and reference diameter equal to or greater than 2.0 mm (visual assessment) with the intravascularultrasound and angiographic restudy at 9 months. Results: Both groups were similar in clinical, angiographic and technical characteristics, except for a higher incidence of arterial hypertension in group 2 (81,5% vs 94,1%, p=0,026) as well as significantly lower coronary stents diameters in group 1 (2,78 mm vs 2,96 mm, p<0,001). The intimal obstruction volume calculated by the intravascularultrasound at 9 months was similar between the groups (33,2% vs 35,1%, p=0,069), as well as the rates of major adverse cardiac events (12,3% vs 8,8%, p= 0,811), stent thrombosis (1,5% versus 0,75%, p= 0,237), in-stent binary restenosis (9,8% vs 6,8%, p= 0,988), in stent late loss (0,60 vs 0,64, p=0,300) and at the segment ( 0,57 vs 0,58, p= 0,387). Conclusions: The addition of cilostazol to the dual antiplatelet therapy with acetylsalicylate acid and clopidogrel, in diabetic patients undergoing stent implantation with zotarolimus did not reduce major adverse cardiac events nor the percentage of intra-stent intimal hyperplasia measured by the intravascularultrasound volumetric analysis.

A expectativa de vida após correção cirúrgica da coarctação da aorta (CoAo) permanece menor que a da população geral, sendo que a maioria das mortes tardias se deve a complicações cardiovasculares, tais como: recoarctação, hipertensão arterial sistêmica (HAS), doença coronária, insuficiência cardíaca, acidente vascular cerebral (AVC) e morte súbita. Já se demonstrou que pacientes com CoAo têm estrutura e função arterial anormais, o que pode persistir mesmo após correção cirúrgica e ser responsável pela morbi-mortalidade tardias. Há pouca informação na literatura em relação ao possível remodelamento arterial após aortoplastia. O objetivo primário desse estudo foi avaliar os efeitos imediatos e após 1 ano da aortoplastia com implante de stent na reatividade e rigidez arteriais, e na espessura do complexo médiointimal (EMI). O objetivo secundário foi correlacionar os achados evolutivos da reatividade, rigidez e espessura médiointimal arteriais entre si. Vinte e um pacientes com idade mediana de 15 anos (8-39 anos) foram estudados antes da aortoplastia e após a intervenção (1 dia, 6 meses e 1 ano). A dilatação fluxo-mediada (DFM), a dilatação induzida por nitrato na artéria braquial esquerda, a velocidade da onda de pulso (VOP) carotídea, e a EMI carotídea e na artéria subclávia direita foram estudadas por meio do ultrassom. Antes do tratamento percutâneo, os pacientes apresentaram dilatação fluxo-mediada (DFM) (3,50 ± 2,01% vs 17,50 ± 3,20%, p<0,0001) e dilatação induzida por nitrato (12,51±3,66% vs 28,44 ± 6,85%, p<0,0001) prejudicadas, VOP aumentada (5,40 ± 0,79 m/s vs 4,32 ± 0,54 m/s, p<0,0001) e EMI em carótidas (0,59 ± 0,09 mm vs 0,49 ± 0,04mm, p<0,0001) e artéria subclávia direita aumentadas (1,20 ± 0,25mm vs 0,69 ± 0,16 mm, p<0,0001). Um ano após aortoplastia, não houve melhora significativa na DFM (3,61±1,86%), dilatação induzida por nitrato (12,80±3,53%), rigidez arterial (5,25 ± 0,77 m/s), EMI carotídea (0,59 ± 0,11 mm) ou EMI da artéria subclávia direita (1,21 ± 0,28 mm). Não houve correlação linear entre rigidez arterial, EMI e DFM. Pacientes submetidos à aortoplastia com balão e implante de stent não apresentaram melhora da reatividade arterial, rigidez arterial e EMI. Não houve correlação da rigidez arterial, EMI e DFM entre si. / Life expectancy after surgical repair of aortic coarctation (CoA) remains lower than general population and the majority of late deaths are due to cardiovascular complications, such as recoarctation, systemic arterial hypertension (SAH), coronary artery disease, heart failure, stroke and sudden death. It has been shown that patients with CoA have abnormal arterial structure and function, which may persist even after surgery and may be responsible for late morbidity and mortality. There is little information regarding arterial remodeling after angioplasty. The primary objective of this study was to evaluate immediate and one year results after aortic stenting on arterial reactivity and stiffness and intima-media thickness (IMT). The secondary objective was to correlate arterial reactivity, arterial stiffness and IMT. Twenty-one patients with a median age of 15 years (8-39 years) were studied before and after aortic stenting (1 day, 6 months and 1 year). The flow-mediated dilation (FMD) and nitrate-mediated dilation in left brachial artery, pulse wave velocity (PWV), carotid IMT and right subclavian artery IMT were studied by ultrasound. Before the percutaneous treatment, the patients had impaired FMD (3.50 ± 2.01% vs. 17.50 ± 3.20%, p<0.0001) and nitrate-mediated dilation (12.51 ± 3.66% vs. 28.44 ± 6.85%, p<0.0001), increased PWV (5.40 ± 0.79m/s vs. 4.32 ± 0.54m/s, p<0.0001), increased both carotid IMT (0.59 ± 0.09mm vs. 0.49 ± 0,04mm, p<0.0001) and right subclavian artery IMT (1.20 ± 0.25mm vs. 0.69 ± 0 16mm p <0.0001). One year after angioplasty, there was no significant improvement in FMD (3.61 ± 1.86%), nitrate-mediated dilation (12.80 ± 3.53%), arterial stiffness (5.25 ± 0.77 m/s), carotid IMT (0.59 ± 0.11mm) or right subclavian artery IMT (1.21 ± 0.28 mm). There was no linear correlation between arterial stiffness, IMT and FMD. Patients undergoing balloon angioplasty and stenting showed no improvement in arterial reactivity, arterial stiffness and IMT. There was no correlation among arterial stiffness, IMT and FMD.

FUNDAMENTOS: Com a expressiva ampliação do uso dos stents farmacológicos (SF), nos diversos cenários em que se apresenta a doença arterial coronária (DAC), e diante de todas as evoluções das diferentes formas de tratamento, levantou-se o questionamento sobre a propriedade de indicação da intervenção coronária percutânea (ICP), à busca do discernimento sobre quais pacientes (P) com DAC apresentam o melhor balanço risco/benefício. Visando a sistematizar as indicações para procedimentos de RM, e tomando como referência as Diretrizes Internacionais baseadas nos principais estudos e ensaios clínicos desta área, em 2009, pela primeira vez, ACC/AHA/SCAI/AATS publicaram um documento sugerindo, frente aos diversos cenários clínicos e anatômicos da DAC, critérios de propriedade de indicação para os procedimentos de RM, permitindo classificá-los quanto à indicação em: A - apropriado, PA - pode ser apropriado ou RA - raramente apropriado. OBJETIVOS: O objetivo primário foi avaliar o grau de propriedade de indicação da ICP com SF nos pacientes do Registro DESIRE, no período de Janeiro de 2012 a Dezembro de 2013, correlacionando com a ocorrência de eventos cardíacos maiores (ECAM) (óbito, infarto e revascularização da lesão-alvo), num seguimento clínico de dois anos. Os objetivos secundários foram: comparar o grau de propriedade de indicação da ICP entre pacientes com apresentação clínica estável versus aqueles com síndrome coronária aguda (SCA); e a ocorrência isolada de óbito cardíaco (OC), infarto agudo do miocárdio não-fatal (IM), revascularização da lesão-alvo (RLA) e trombose do stent no período de follow-up. CASUÍSTICA E MÉTODOS: Foram incluídos todos os pacientes, consecutivamente tratados no HCor-ASS com ICP e implante de pelo menos um SF, entre 01/01/2012 a 31/12/2013. A coleta de dados foi feita do banco de dados do Registro DESIRE, em cujo programa constam dados pormenorizados das características clínicas, angiográficas e informações técnicas da intervenção, incluindo complicações, de cada um dos P registrados, além dos dados evolutivos obtidos nos períodos definidos após o procedimento-índice (1, 6, 12 meses e anualmente a partir de então). Fez-se a validação desses critérios, usando-se o aplicativo SCAI-QIT®, que permite a definição, ao serem incluídas as variáveis do P, do grau de propriedade de indicação para o implante do SF. Este aplicativo é facilmente acessado via internet, no seguinte site: http://scai-qit.org/. Após ser feita a classificação dos critérios de propriedade de indicação, os dados foram analisados estatisticamente, para obtenção dos objetivos e resultados do estudo em questão. RESULTADOS: Dentre os 1.108 P do Registro DESIRE analisados, usando-se o aplicativo SCAI-QIT®, observou-se que: 375 (33,8%) tiveram indicações Apropriada (Grupo I); 480 (43,3%) tiveram indicação Pode Ser Apropriada (Grupo II) e 215 (19,4%) tiveram indicação Raramente Apropriada (Grupo III). No Grupo I, 22,7% tinham isquemia silenciosa, 13,3% angina estável, 36,8 % SCAssST e 27,2% SCAcsST. No Grupo II, 34,0% tinha isquemia silenciosa, 11,9% angina estável, 33,3% SCAssST e 20,8% SCAcsST. No Grupo III, 82,3% tinham isquemia silenciosa, 4,2% angina estável, 0% SCAssST e 13,5% SCAcsST. A ocorrência de IM (definido como aumento da CKMB massa >3X o percentil 99) foi de 9,6%, 9,6%% e 7,0% (p= 0,652) nos Grupos I, II e III, respectivamente. A RLA foi de 1,9%, 2,1% e 0,9% (p= 0,592) e a taxa de trombose do stent foi 0,3%, 0,6% e 1,4% (p=0,406). Comparando os 3 grupos não foi estatisticamente significativo as taxas de OC e ECAM no follow-up de 2 anos. CONCLUSÕES: Os resultados deste estudo demonstram que apesar das taxas de PCI em pacientes estáveis e instáveis, destoarem das esperadas e das já documentadas, isso não teve relevância nos eventos maiores e sobrevida dos pacientes no follow-up clínico. / BACKGROUND: With the significant expansion of the use of drug-eluting stents in different scenarios as presented coronary artery disease (CAD), and before all the developments of different forms of treatment, rose the questioning on the indication of ownership of percutaneous coronary intervention (PCI), the pursuit of insight into which patients (P) with CAD have the best balance risk/benefit. Aiming to systematize indications for coronary revascularization procedures, and by reference to the International Guidelines based on the main studies and clinical trials in this area, in 2009 for the first time, ACC/AHA/SCAI/AATS published a paper suggesting, compared to various clinical and anatomical scenarios of CAD, criteria for appropriate indication of coronary revascularization procedures, allowing to classify them as the indicated in: A - Appropriate, PA - May be appropriate or RA - Rarely appropriate. OBJECTIVES: The primary objective was to evaluate the degree of appropriateness of the ICP with pharmacological stents in patients of DESIRE Registry, in the period from January 2012 to December 2013, correlating with the occurrence of major cardiac events (MACE)(death, myocardial infarction and target vessel revascularization), in the clinical follow-up of two years. The secondary objective were: to compare the degree of appropriateness of PCI indication among patients with clinical presentation satble versus those with acute coronary syndrome to isolated occurrence of cardiac death, myocardial infarction (MI), new target lesion revascularization (TLR) and stent thrombosis in follow-up period. METHODS: We included all patients consecutively treated in HCor-ASS with ICP and implantation of at least one drug-eluting stent, between 01/01/2012 to 31/12/2013. Data collection was made of the DESIRE Registry data base in whose program includes these full details of clinical features, and technical information of the intervention, including complications, each of registered patients in addition to the rolling data over defined periods after the index procedure (1, 6 12 months and annually thereafter). It was made the validation of these criteria, using the application SCAI-QIT, which allows definition, when the patient variables are include, the degree of appropriateness implantation of drug-eluting stent. This application is easily accessed via the internet, at the following site: http://scai-qit.org/. After being made the classification of statement of appropriateness criteria, data were statistically analyzed to obtain the objectives and results of the study in question. RESULTS: Among the 1.108 P of DESIRE Registry analyzed using the SCAI-QIT® application, it was observed that: 375 (33,8%) had Appropriate(Group I) indication; 480 (43,3%) had May be appropriate (Group II) indication and 215 (19,4%) had Rarely appropriate (Group II) indication. In Group I, 22,7% had silent ischemia, 13,3% stable angina, 36,8% SCAssST e 27,2% SCAcsST. In Group II, 34,0% had silent ischemia, 11,9% stable angina, 33,3% SCAssST e 20,8% SCAcsST. No Group III, 82,3% had silent ischemia, 4,2% stable angina, 0% SCAssST e 13,5% SCAcsST. The occurrence of MI (defined as increase of CKMB mass >3x the 99 percentile) was 9,6%, 9,6%% and 7,0% (p= 0,652) in Groups I, II e III, respectively. The TLR was 1,9%, 2,1% and 0,9% (p= 0,592) and stent thrombosis rate was 0,3%, 0,6% and 1,4% (p=0,406). Comparing the 3 groups was not statistically significant the rates of mortality and mace in follow-up of 2 years. CONCLUSIONS: The results of this study demonstrate that despite PCI in stable and unstable patients, diverges the expected and already documented, it had no relevance in major events and survival of patients in the clinical follow-up.

Introdução: Os traumas arteriais e venosos são responsáveis por expressiva morbimortalidade, e, em determinados territórios, a técnica de restauração aberta acrescenta riscos elevados ao paciente, que podem ser minimizados com o uso de técnicas endovasculares. Objetivos: O objetivo deste estudo foi criar um modelo experimental de trauma vascular periférico penetrante em que se avalia a viabilidade do reparo endovascular em lesões da parede arterial com diferentes extensões cincunferenciais. Método: Vinte porcos brancos machos foram divididos em quatro grupos, de acordo com a extensão circunferencial do trauma arterial: sem lesão arterial (Grupo 1); lesão arterial com extensão circunferencial <50% (Grupo 2); lesão arterial com extensão circunferencial >50%, variando entre 50-80% (Grupo 3); e secção completa (Grupo 4). A artéria carótida comum esquerda foi dissecada com controle arterial proximal e distal, procedimento que se seguiu de secção controlada da parede arterial, fechamento dos planos e compressão manual por dez minutos, seguida de tratamento endovascular com introdução de stent revestido ViabahnTM (5mm x 50 mm) por via de acesso femoral. Resultados: A viabilidade e a reprodutibilidade do modelo experimental proposto foram confirmadas pelo sucesso no tratamento de todos os animais sem trauma e nos animais com lesões <50%. Sucesso da técnica endovascular também foi observado em quatro dos cinco animais com lesões >50% e, em um animal com secção completa. Variáveis como a duração do procedimento, parâmetros ultrassonográficos e arteriográficos, e flutuação dos sinais vitais foram devidamente monitoradas. Conclusões: O reparo endovascular do trauma arterial periférico em animais de experimentação mostrou-se factível com limitação dependendo da extensão circunferencial da lesão. Este modelo experimental, envolvendo técnicas endovasculares, indicou etapas importantes a serem consideradas em outros estudos nestes animais e com a utilização destes materiais. / Background: Additional surgical trauma often increases the risk of major morbidity and mortality associated with vascular injury, and endovascular repair could have many advantages in such situations. Objectives: The aim of this study was to create an experimental animal model of penetrating peripheral artery injury and to evaluate the feasibility of endovascular repair in different degrees of circumferential injury. Methods: Twenty white male domestic pigs were divided into four groups according to the circumferential extent of arterial injury: no injury; circumferential injury extent < 50% or > 50%, ranging between 50- 80%, and complete sectioning. Left common carotid artery was dissected with proximal and distal artery control followed by controlled section of the arterial wall. Local manual compression was applied for 10 minutes followed by endovascular treatment with a 5 x 50 mm ViabahnTM covered stent using the femoral approach. Results: The feasibility and reproducibility of the proposed experimental model was confirmed by the successful treatment of all animals with no injury and with injuries with a circumferential extent < 50%. Success was also achieved in four of the 5 animals in the group with injuries of circumferential extent > 50%, and in one pig in the complete section group. Additional variables were monitored, such as duration of procedure, ultrasound and arteriography parameters and fluctuation of vital signs. Conclusions: Endovascular repair of arterial injury is possible depending on circumferential extension of arterial lesion. This experimental model, involving endovascular techniques, shows important steps to consider in further studies in these animals and use of these materials.

Σκοπός: Η μελέτη είχε ως σκοπό την διερεύνηση της ασφάλειας και της αποτελεσματικότητας των sirolimus-eluting stent, σε σχέση με τα απλά μεταλλικά stent, στα πλαίσια αγγειοπλαστικής των κνημιαίων αγγείων, σε ασθενείς με χρόνια κρίσιμη ισχαιμία του κάτω άκρου. Πρόκειται για μια προοπτική ελεγχόμενη, κλινική μελέτη με διπλό σκέλος. Τα stent τοποθετήθηκαν σε περιπτώσεις μη ικανοποιητικής αγγειοπλαστικής (δηλ. σε περιπτώσεις ελαστικής επαναφοράς-υπολειμματικής στένωσης >30% και σε περιπτώσεις διαχωρισμού). Οι ασθενείς ελέγχθηκαν κλινικά και αγγειογραφικά στο εξάμηνο και στο 1 έτος. Ασθενείς και μέθοδοι: 29 ασθενείς, εκ των οποίων 8 γυναίκες και 21 άνδρες, με μέση ηλικία τα 68,7 έτη υποβλήθηκαν σε αγγειοπλαστική στα κνημιαία αγγεία, με απλά μεταλλικά stent, ομάδα Β. Σε αυτή την ομάδα τοποθετήθηκαν απλά stent σε 65 αλλοιώσεις, εκ των οποίων 38 στενώσεις και 27 αποφράξεις σε συνολικά 40 κνημιαία αγγεία. Άλλοι 29 ασθενείς, 8 γυναίκες και 21 άνδρες, με μέση ηλικία τα 68,8 έτη αντιμετωπίστηκαν με sirolimus-eluting stent, ομάδα S. Σε αυτή την ομάδα αντιμετωπίστηκαν 66 αλλοιώσεις εκ των οποίων 46 στενώσεις και 20 αποφράξεις, σε 41 συνολικά αγγεία. Οι ασθενείς επανελέγχθηκαν κλινικά και με ενδαρτηριακή αγγειογραφία στους 6 μήνες και στο 1 έτος, μετά την αρχική επέμβαση. Έγινε στατιστική ανάλυση των αποτελεσμάτων. Αποτελέσματα: Οι συνοδές νόσοι ήταν περισσότερες στην ομάδα S (όπως η συμπτωματική νόσος από την καρδιά και τις καρωτίδες, καθώς και η υπερλιπιδαιμία, p<0.05). Η τεχνική επιτυχία ήταν 96,6% (28/29 άκρα) στην ομάδα Β έναντι 100% (29/29 άκρα) στην ομάδα S (p=0.16) Στον επανέλεγχο εξαμήνου: Η βατότητα ήταν 68,1% στην ομάδα Β και 92,0% στην ομάδα S, (p<0.002). Τα μεγαλύτερα ποσοστά βατότητας των sirolimus-eluting stent, μετά από πολυπαραγοντική regression analysis είχαν OR 5.625, με 95% CI 1.711- 18.493, που ήταν στατιστικά σημαντικό (p=0.004). Η δυαδική επαναστένωση εντός του stent ήταν 55,3% ενώ η επαναστένωση στα άκρα του stent ήταν 66,0% στους ασθενείς με τα απλά μεταλλικά stent. Αντιθέτως τα ποσοστά στους ασθενείς με sirolimus-eluting stent ήταν 4,0% και 32,0% αντίστοιχα. Συγκεκριμένα η επαναστένωση εντός του stent είχε OR 0.067, με 95% CI 0.021-0.017, και η επαναστένωση στα άκρα του stent είχε OR 0.229 με 95% CI 0.099-0.533. Και τα δύο ήταν ήταν στατιστικά σημαντικά με p<0.001 και p=0.001, αντίστοιχα. Τα συνολικά ποσοστά επανεπέμβασης (TLR) στο εξάμηνο ήταν 17,0% στην ομάδα Β έναντι 4,0% στην ομάδα S, (OR 0.057, με 95% CI 0.008-0.426). Το αποτέλεσμα ήταν επίσης στατιστικά σημαντικό υπέρ των sirolimus stent. (p=0.02) Η διάσωση του άκρου ήταν 100% και στις δύο ομάδες. Η θνησιμότητα και ο ελάσσων ακρωτηριασμός στο εξάμηνο ήταν 6,9% και 17,2% στην ομάδα Β έναντι 10,3% και 3,4% στην ομάδα S (p=0.32 και p=0.04, αντίστοιχα). Στον επανέλεγχο έτους: Τα sirolimus-eluting stent σχετίζoνταν και πάλι με καλύτερη πρωτογενή βατότητα (OR 10.401, με 95% CI 3.425-31.589, p<0.001) και σημαντικά μειωμένη δυαδική επαναστένωση εντός του stent (OR 0.156, με 95% CI 0.060-0.407, p<0.001), καθώς και στα άκρα του stent. (OR 0.089, με 95% CI 0.023-0.349, p=0.001) Τα ποσοστά επανεπέμβασης στις βλάβες (TLR) ήταν πολύ μικρότερα στην ομάδα του sirolimus (OR 0.238, με 95% CI 0.067-0.841, p=0.026) . Δεν υπήρξαν στατιστικά σημαντικές διαφορές ανάμεσα στις δύο ομάδες Β και S όσον αφορά στα ποσοστά θνησιμότητας 10,3% έναντι 13,8%, στη διάσωση του άκρου 100% έναντι 96% και στους ελάσσονες ακρωτηριασμούς 17,2% έναντι 10,3% αντίστοιχα. Συμπεράσματα: Τα sirolimus-eluting stents περιορίζουν την ενδοθηλιακή υπερπλασία στα κνημιαία αγγεία. Η εφαρμογή τους έχει ως αποτέλεσμα την σημαντική μείωση των ποσοστών επαναστένωσης και μειώνει την ανάγκη για επανεπεμβάσεις. / Aim : The purpose of our study was to investigate the 6-month and 1-year angiographic and clinical outcome in the setting of a controlled clinical study. The study examined the safety and relative effectiveness of sirolimus-eluting stents opposed to conventional metal stents, in the infrapopliteal vessels, in patients with critical limb ischemia (CLI). The stents were used in a bail-out setting during infrapopliteal endovascular procedures, i. e. stenting was carried out in cases of suboptimal angioplasty results (recoil - residual stenosis >30%, or in cases of dissection, after angioplasty). Patients and Methods: Twenty-nine patients comprising 8 women and 21 men with a mean age of 68.7 years were submitted to infrapopliteal revascularization with conventional (bare) metal stents, called group B. In these patients 65 lesions were treated with bare stents, of whom 38 stenoses and 27 occlusions, in a total of 40 infrapopliteal vessels. Another 29 patients, again 8 women and 21 men, with a mean age of 68.8 years were treated with sirolimus-eluting stents, named group S. There were 66 lesions in this group with 46 of them stenoses and 20 occlusions, in a total of 41 arteries. Patients were followed-up with clinical examination and intrarterial angiography 6 months and 1 year after the procedure. Both results were subsequently analyzed statistically. 135 Results: Co morbidities like symptomatic cardiac and carotid disease, as well as hyperlipidemia were more prominent in group S (p<0.05). Technical success was 96.6% (28/29 limbs) in group B against 100.0% (29/29 limbs) in group S (p=0.16). During 6-month patient follow-up: Primary patency was 68.1% in group B opposed to 92.0% in group S (p<0.002). Sirolimus-eluting stents exhibited higher primary patency with OR 5.625 and 95% CI 1.711-18.493, which was statistically significant (p=0.004). Binary in-stent restenosis rate was 55.3% while in-segment restenosis was 66.0%, in patients who had received bare metal stents. In opposition the respective restenosis rates, in patients with sirolimus-eluting stents were 4.0% and 32.0%. Diminished in-stent (OR 0.067 with 95% CI 0.021-0.017) and insegment (OR 0.229 with 95% CI 0.099-0.533) binary restenosis were both statistically significant with p values being p<0.001 and p=0.001 respectively. Collective target lesion re-intervention (TLR) at 6 month follow-up was 17.0% in group B against 4.0% (OR 0.057 with 95% CI 0.008-0.426) in group S, which proved again statistically significant for sirolimus stents (p=0.02). Six-month limb salvage rate was 100% in both groups. Six-month mortality and minor amputation rates were respectively 6.9% and 17.2%, in group B versus 10.3% and 3.4%, in group S (p=0.32 and p=0.04, respectively). During 1-year patient follow-up: 136 SES were still related with better primary patency rate (OR 10.401 with 95% CI 3.425-31.589, p<0.001) and considerably lesser events of in-stent binary restenosis (OR 0.156, 95% CI 0.060-0.407, p<0.001) as well as insegment (OR 0.089, 95% CI 0.023-0.349, p=0.001) binary restenosis. Target lesion re-intervention (TLR), was much lower in the SES patients group during 1-year follow-up (OR 0.238 with 95% CI 0.067-0.841, p=0.026) . At 1 year follow-up there were no statistically significant differences among group B and group S regarding mortality (10.3% against 13.8%), limb salvage rates (100% vs. 96%) and minor amputation (17.2% vs. 10.3%). Conclusions: Sirolimus-eluting stents appear to limit intimal hyperplasia in the infrapopliteal vessels. The use of sirolimus-eluting stents decreases considerably restenosis rates in the infrapopliteal vessels and reduces the need for repeat interventions

Introdução: Os stents farmacológicos (SF) de primeira geração surgiram com o intuito de reduzir as taxas de reestenose intra-stent e de revascularização da lesão-alvo, sendo mais eficazes quando comparados aos stents não-farmacológicos (SNF), porém com aumento de risco de trombose do stent (TS) muito tardia. A cobertura tecidual incompleta e a má aposição tardia das hastes dos stents podem estar vinculadas à TS. O SF de segunda geração BioMatrix®, que utiliza um polímero bioabsorvível, surgiu na expectativa de redução da TS. Devido à alta acurácia e reprodutibilidade e à análise precisa da cobertura tecidual e da aposição das hastes dos stents, a tomografia de coerência óptica (TCO) vem se tornando um método útil na análise desses aspectos. O objetivo desse estudo foi avaliar a cobertura tecidual e a aposição das hastes do SF BioMatrix® após longo período do implante. Métodos: Vinte pacientes submetidos ao implante do SF BioMatrix® (n = 15) ou do SNF S-Stent® (n = 5) foram acompanhados por um período mínimo de cinco anos e avaliados por meio da angiografia coronária quantitativa (ACQ), da ultrassonografia intracoronária (USIC) e da TCO. Para a análise estatística, foram utilizados os programas SPSS® versão 16.0 e SAS versão 9.2. O valor de p < 0,05 era considerado estatisticamente significante. As variáveis categóricas foram expressas em números absolutos e porcentuais e comparadas pelo teste exato de Fisher. As variáveis contínuas foram expressas em média e desvio padrão e/ou mediana e intervalo interquartílico e foram comparadas pelo teste não paramétrico de Mann-Whitney. Resultados: A ACQ demonstrou diferença, porém não significativa na perda tardia da luz entre o SF BioMatrix® e o S-Stent® [0,40 (0,21; 0,77) mm vs 0,68 (0,66; 0,82) mm, p = 0,205]. Os pacientes tratados com o SF BioMatrix® apresentaram porcentual de obstrução do stent significativamente menor quando comparados àqueles que receberam o S-Stent® [5,6 (4,4; 9,7)% vs 28,6 (24,7; 29,0)%, p =0,001]. A análise da TCO demonstrou 126 (8,7%) hastes não cobertas nos stents BioMatrix® e 23 (4,0%) nos S-Stents® (p = 0,297), estando a maioria delas bem apostas (117/126 e 21/23, respectivamente, p = 0,292). Apenas nove (0,6%) hastes nos SF e duas (0,4%) hastes nos SNF estavam simultaneamente sem cobertura tecidual e mal apostas (p = 0,924). No grupo BioMatrix®, apenas 1 (11,1%) paciente teve todas as hastes cobertas. Já no grupo S-Stent, 66,7% dos pacientes (2/3) apresentaram cobertura completa das hastes (p = 0,127). Conclusões: A avaliação tardia do SF BioMatrix® pela TCO mostrou cobertura tecidual e aposição em quase a totalidade de suas hastes, de maneira similar àquela encontrada nos SNF S-Stents®. / Introduction: First generation drug-eluting stents (DES) have emerged as a strategy to prevent in-stent restenosis and the need of target-vessel revascularization when compared to bare metal stents (BMS); but at the expense of a higher risk of very late stent thrombosis (ST). Uncovered and malapposed struts may be associated with both late and very late ST. It has been postulated that the second generation DES, the biolimus-eluting stent BioMatrixTM with biodegradable polymer, may reduce the incidence of ST. Given its high accuracy and reproducibility with precise analysis of the complete strut apposition and strut coverage, the optic coherence tomography (OCT) has been extensively used for stent analysis. The aim of this study was to assess the struts coverage and apposition of DES BioMatrixTM in a long-term follow up. Methods: Twenty patients undergoing a BioMatrixTM (n = 15) or BMS S-StentTM (n = 5) implantation were followed up for a period of at least five years and evaluated by means of OCT, quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS). All statistical analyses were performed using SPSSTM (v.16.0) and SAS (v.9.2) software. Statistical significance was considered at p values < 0.05. Categorical variables were expressed as counts and percentages, and continuous variables as mean SD and/or median and interquartile range. For per-patient level comparison, the difference between two stent types was evaluated by nonparametric Mann-Whitney U test while categorical variables were evaluated by the Fisher exact test. Results: QCA analysis showed no differences in the occurrence of intrastent late loss between the groups [0.40 (0.21; 0.77) mm vs 0.68 (0.66; 0.82) mm, p = 0.205 for BioMatrixTM and S-StentsTM, respectively]. The vessel, stent and lumen volumes assessed by IVUS after the procedure and 5 years later were similar between the two groups. Patients treated with BioMatrixTM had significantly less stent obstruction percentage when compared to those treated with S-StentTM [5.6 (4.4; 9.7)% vs 28.6 (24.7; 29.0)%, p = 0.001]. OCT analysis demonstrated 126 (8.7%) uncovered struts in the BioMatrixTM group compared to 23 (4.0%) in the S-StentsTM group (p = 0.297), being the majority of them well apposed (117/126 and 21/23, respectively, p = 0.292). Only 9 (0.6%) struts in the DES and 2 (0.4%) struts in the BMS groups were imultaneously uncovered and malapposed (p = 0.924). Among the BioMatrixTM patients, 55.6% (5/9) had more than 95% of covered struts and in only 1 (11.1%) patient all struts were covered. On the other hand, among the S-StentTM patients, 66.7% (2/3) had complete covered struts (p = 0.127). Conclusion: Long term assessment of DES BioMatrixTM by OCT showed tissue coverage and apposition in almost all struts, similary to those found in the BMS S-StentsTM.

Introdução: as próteses metálicas autoexpansíveis (PMAE) são consideradas a melhor forma de tratamento paliativo da disfagia para pacientes com câncer avançado de esôfago. Os eventos adversos (EA) são uma grande preocupação, especialmente em pacientes com melhor prognóstico e maior sobrevida. O presente estudo teve como objetivo avaliar os EA de pacientes que sobreviveram por mais de 6 meses com a prótese esofágica no local. Métodos: análise retrospectiva de um banco de dados coletado prospectivamente incluindo todos os pacientes submetidos à colocação de prótese esofágica para o tratamento paliativo de doenças malignas e que permaneceram com a prótese por mais de 6 meses, durante o período de fevereiro de 2009 a fevereiro de 2014 em um centro acadêmico terciário. Resultados: sessenta e três pacientes foram incluídos. O seguimento médio foi de 10,7 meses. O sucesso clínico foi alcançado em todos os pacientes e a mediana da patência da prótese foi de 7,1 meses. Eventos adversos ocorreram em 40 pacientes (63,5%), totalizando 62 EA (média de 1,5 EA por paciente). O manejo endoscópico dos EA foi bemsucedido em 84,5% dos casos, com uma média de 1,6 reintervenções por paciente. A análise univariada revelou que a capacidade funcional, a idade e a radioterapia pós-prótese apresentaram tendência ao maior risco de EA. A análise multivariada revelou que apenas a capacidade funcional foi associada a EA (p = 0,025; HR = 4,1). Conclusão: eventos adversos são comuns em pacientes com prótese metálica de esôfago por período prolongado para paliação de doenças malignas. No entanto, o evento adverso não foi relacionado com maior taxa de mortalidade, e a maioria das complicações pôde ser manejada endoscopicamente com sucesso. Apenas a capacidade funcional foi um fator de risco para os EA. Os presentes dados sugerem que a prótese metálica é uma opção válida para a paliação de condições esofágicas malignas, mesmo quando se espera sobrevida maior que 6 meses / Background and Aims: self-expandable metallic stents (SEMS) are considered the best palliative treatment of dysphagia for patients with advanced esophageal cancer. Adverse events (AE) are a major concern, especially in patients with better prognosis and longer survival. The present study aimed to evaluate the AE of patients who survived longer than 6 months with esophageal stents in place. Methods: retrospective analysis of a prospectively collected database including all patients submitted to esophageal stent placement for the palliation of malignant diseases, during the period from February 2009 to February 2014 at a tertiary-care academic center, who remained with the stent longer than 6 months. Results: sixtythree patients were included. Mean follow-up was 10,7 months. Clinical success was achieved in all patients, and the median stent patency was 7,1 months. Adverse events occurred in 40 patients (63.5%), totaling 62 AE (mean 1.5 AE per patient). Endoscopic management of AE was successful in 84.5% of cases, with a mean of 1.6 re-interventions per patient. The univariate analysis revealed that performance status, age and post-stent radiotherapy presented a trend to higher risk of AE. The multivariate analysis revealed that only performance status was associated with AE (p = 0,025; HR = 4.1). Conclusions: AE are common in patients with long-term esophageal stenting for malignancy. However, AE was not related to higher mortality rate, and most complications could be successfully managed by endoscopy. Only performance status was a risk factor for AE. Our data suggest that metallic stenting is a valid option for the treatment of malignant esophageal conditions, even when survival longer than 6 months is expected

Introdução: O Stent Carotídeo (SC) surgiu como uma alternativa à cirurgia de endarterectomia para o tratamento de estenose carotídea extracraniana com o objetivo de prevenir o acidente vascular encefálico (AVE). O sucesso do SC depende de estratégias que minimizem o risco de AVE. No início do estudo não existiam estudos randomizados comparando o implante de stent carotídeo com diferentes tipos de proteção cerebral. Objetivos: Testar de forma aleatória a eficácia de dois diferentes princípios de proteção embólica no território carotídeo (Angioguard®) e Mo.Ma), utilizando a ressonância magnética ponderada em Difusão (RM-PD) para detectar novas lesões isquêmicas no encéfalo analisando número, tamanho e localização. Métodos: Sessenta pacientes submetidos ao implante do stent carotídeo (SC), foram alocados aleatoriamente para utilizar filtro distal Angioguard® (30 pacientes) e balão de oclusão proximal Mo.Ma (30 pacientes) desde julho de 2008 a 2011. Todos os pacientes realizaram RM-PD pré e 48 horas pós o SC. Os resultados foram avaliados por neurologista independente e cego ao tipo de proteção cerebral utilizada. Foram acompanhados por um período de pelo menos um ano. Os dados qualitativos foram resumidos em frequências absolutas e relativas (porcentagens) e comparados utilizando o teste quiquadrado com correção de continuidade de Yates ou o teste exato de Fisher. Os dados quantitativos foram expressos em médias e desvio-padrão, e/ou medianas e intervalos interquartis e foram comparadas utilizando o teste t de Student ou não paramétrico de Mann-Whitney. Resultados: Não houve diferença estatisticamente significativa em quanto a antecedentes clínicos ou características das lesões carotídeas entre os grupos, apenas as lesões eram mais calcificadas no grupo Angioguard® (p < 0,01). Não houve diferença entre os grupos quanto a incidência de novas lesões isquêmicas (63,3% do Angioguard® vs 66,7% do Mo.Ma, p = 0,787). Quando presentes, as lesões isquêmicas por pacientes o fizeram em número significativamente menor no grupo Mo.Ma, entre 1 e 43 lesões (mediana = 6), comparado ao grupo AngioguardÒ, entre 1 e 76 lesões (mediana = 10) com p < 0,001. Três pacientes (5%) apresentaram eventos neurológicos em até 30 dias e no seguimento de um ano, 1 paciente teve um infarto agudo do miocárdio. Conclusão: Foram observadas novas lesões isquêmicas cerebrais em mais de 60% dos pacientes que utilizaram os dois dispositivos de proteção cerebral, entretanto houve significativamente menos lesões por paciente no grupo Mo.Ma, com significância estatística p = < 0,001. A maioria das lesões foi pequena < 0,5 mm, e encontradas em território ipsilateral. Não foi observado óbito ou AVE maior no seguimento de pelo menos um ano. / Background: Carotid Stent (CAS) has emerged as an alternative to surgical carotid endarterectomy for the treatment of extracranial carotid stenosis in order to prevent stroke. The success of the CAS depends on estrategies that minimize the risk of stroke. When this study began there were no randomized trial comparing different types of cerebral protection during carotid stenting. Objectives: Randomly test the effectiveness of two different embolic protection principles in carotid artery (Angioguard®) vs Mo.Ma) using diffusion-weighted magnetic resonance imaging (DWI) to detect new ischemic lesions in the brain, analyzing the number, size and location of this new ischemic lesions between groups. Methods: Sixty patients undergoing CAS, were randomly assigned to use distal filter AngioguardÒ (30p) and proximal balloon occlusion Mo.Ma (30p) from July 2008 to July 2011. All patients underwent DWI before and 48 hours after the CAS. The results were evaluated by an independent neuroradiologist blind to the type of cerebral protection used. The patients were followed during at least year. Qualitative data were summarized as absolute and relative frequencies (percentages) and compared using chisquare test with Yates continuity correction or Fisher\'s exact test. Quantitative data were expressed as means and standard deviations, and / or medians and interquartile ranges and were compared using the Student t test or nonparametric Mann-Whitney test. Results: Demographic, clinical and lesion characteristics were not different between the two groups, there were more calcified lesion in the Angioguard® group (p < 0.001). There was no difference between groups regarding the incidence of new ischemic lesions in the Angioguard® group compared to the Mo.Ma group (63.3% vs 66.7% p = 0.787). When present, the number of ischemic cerebral lesions per pacient were in fewer number in the Mo.Ma group (1 to 43 lesions; median = 6) compared to the Angioguard® group (1 to 76 lesions; median = 10) p < 0.001 and this difference was significant. Three patients (5%) had neurological events within 30 days with complete regression of symptoms, and one patient develop an infarction during the first year of follow-up. Conclusions: There were new cerebral ischemic lesions detected by DWI in more than 60% of the patients in both groups, on the other hand there were significantly fewer lesions per patient in those allocated to Mo.Ma as compared to Angioguard® with statistical significance p = 0.001. Most lesions were small < 0.5mm, and localized in ipsilateral territory. There was no death or disabling stroke in at least one year of follow-up.