Background: There is no study focusing on changes of coronary atherosclerosis during dual hypolipidemic therapy with statin and ezetimibe. Methods: 107 patients with stable angina were enrolled and the final analysis was performed in 89 patients. Randomization was 1:1 to the group A (atorvastatin 80mg and ezetimibe 10mg) and to the standard group S. Treatment period was 12 months. Results: Changes of percent atheroma volume (PAV) were -0,4% in group A and + 1,4% in group S, p=0,014. Combine atherosclerosis regression (increase of lumen volume together with decrease of PAV) was found more frequent in group A (40,5%) than the group S (14,9%), p=0,007. The target LDLc level < 2mmol/l, presence of at least four of five atherosclerotic risk factors, and decrease of VCAM level were independent predictors for plaque regression. There were no significant differences in plaque composition between the two groups over the duration of the study. However during analysis the two groups together, fibrous and fibro-fatty tissues decreased and dense calcification and necrotic core increased during follow-up. Conclusion: The dual hypolipidemic therapy starts atherosclerosis regression. Despite significant decrease of lipid levels the continuous plaque shift from fibro and fibro-fatty to necrotic with calcification...

Background: There is no study focusing on changes of coronary atherosclerosis during dual hypolipidemic therapy with statin and ezetimibe. Methods: 107 patients with stable angina were enrolled and the final analysis was performed in 89 patients. Randomization was 1:1 to the group A (atorvastatin 80mg and ezetimibe 10mg) and to the standard group S. Treatment period was 12 months. Results: Changes of percent atheroma volume (PAV) were -0,4% in group A and + 1,4% in group S, p=0,014. Combine atherosclerosis regression (increase of lumen volume together with decrease of PAV) was found more frequent in group A (40,5%) than the group S (14,9%), p=0,007. The target LDLc level < 2mmol/l, presence of at least four of five atherosclerotic risk factors, and decrease of VCAM level were independent predictors for plaque regression. There were no significant differences in plaque composition between the two groups over the duration of the study. However during analysis the two groups together, fibrous and fibro-fatty tissues decreased and dense calcification and necrotic core increased during follow-up. Conclusion: The dual hypolipidemic therapy starts atherosclerosis regression. Despite significant decrease of lipid levels the continuous plaque shift from fibro and fibro-fatty to necrotic with calcification...

No description available.

Em 2010, doenças cardiovasculares (CVD) causaram 33% do total das mortes no Brasil. O acúmulo de placas lipídicas, calcificadas e/ou fibrosas em vasos sanguíneos é chamado aterosclerose e é uma das principais causas da maioria das internações por doenças coronárias. A implantação de stent é um dos métodos mais comuns para o tratamento de pacientes com obstrução nas coronárias, mas este pode desencadear um crescimento de uma nova íntima e causar novamente o estreitamento do vaso, resultando em problemas de irrigação do coração. Alternativas como Tomografia por Coerência Óptica Intravascular (IOCT) oferecem imagens in vivo para detecção e monitoramento da progressão de CVDs. Adicionalmente, métodos computacionais aplicados a imagens IOCT podem fornecer dados objetivos de estruturas como áreas, perímetros, etc., permitindo mais precisão no diagnóstico. Contudo, ainda é pequena a variedade de métodos quantitativos aplicados a IOCT na literatura, em comparação a outras modalidades relacionadas. Neste trabalho é proposto um método para quantificação da neoíntima após a implantação de stent, fornecendo assim informações para possíveis tratamentos. Para isto são utilizadas imagens reais de IOCT de diferentes fontes: humanos, porcos e coelhos, adquiridas em diferentes períodos após a implantação do stent. Primeiro, é segmentada a parede do vaso (Lúmen), por meio da utilização de modulação de intensidade, filtragem, Fuzzy connectedness e binarização por limiar, seguida de um teste de Branch Opening e um conjunto de operações morfológicas. Segundo, o stent é identificado e segmentado, utilizando características extraídas de derivadas gerando imagens auxiliares à imagem de IOCT seguido pelo emprego de operações de seleção dos possíveis pontos pertencentes ao Stent. Tendo o lúmen e o stent segmentados, a área correspondente à neointima pode ser calculada, executando esse procedimento em imagens do mesmo local adquiridas em períodos diferentes. Assim pode ser feita a quantificação do crescimento de tecido. Para a avaliação do método, é comparada a área segmentada do lúmen e do stent, com os métodos propostos, com a área segmentada manualmente por especialistas (Gold Standard). / In 2010, cardiovascular disease (CVD) caused 33% of the total deaths in Brazil. The accumulation of lipidic, calcified and fibrous plaque, in the vessel wall is called atherosclerosis, and it is the main reason of most admissions in hospitals due to coronary heart disease. The stent implantation is one of the most common methods for coronary obstruction treatment, but this can trigger a neo-intima restenosis, and cause again narrowing of the vessel wall, resulting again in heart-irrigation problems. Modalities such as Intravascular Optical Coherent Tomography (IOCT) can be important for this kind of investigations, because it provides coronary in vivo for detecting and monitoring the progression of CVDs. Additionally, computational methods applied to IOCT images, can render objective structure information, such as areas, perimeters, etc., allowing for more accurate diagnosis. However, the variety of methods in the literature applied in IOCT is still small compared to other related modalities. Therefore, we propose a method for neointima restenosis quantification after stent implantation, thereby providing information to potential treatments. Consequently, we used real IOCT images from different sources: humans, pigs, and rabbits, acquired in different periods after stent implantation. First, the lumen is segmented by using intensity modulation and filtering, next fuzzy connectedness and thresholding is carried out, followed by a \"Branch Opening\" test and a set of morphological operations. Second, the stent is identified and segmented using extracted features by derivative operations, generating auxiliary images to the IOCT. Finally, a set of operations to identify and to select possible points which belong to Stent is performed. Having the lumen and stent segmented the area corresponding to the neo-intima can be calculated. By performing the same procedure in images acquired from the same location at different times, the ratio of the neointima growing can be computed. The evaluation is carried out by comparing the segmented new intima area between the proposed and manual method executed by specialist (Gold Standard).

Ischaemic heart disease remains the single leading cause of death throughout the world. Rupture of an advanced atheromatous coronary plaque precipitates the majority of these clinical events, resulting in thrombosis and myocardial infarction. Post-mortem studies have identified thin-cap fibroatheroma (TCFA) as the plaque subtype most prone to rupture with prospective virtual-histology intravascular ultrasound (VH-IVUS) studies linking VH-TCFA to future adverse clinical events. VH-TCFA are however common along the coronary tree with the majority remaining clinically silent, suggesting that factors other than plaque phenotype play an important role in determining rupture and future plaque behaviour. Rupture is thought to occur when the structural stress within the plaque exceeds the material strength of the overlying fibrous cap. Previous histological work has demonstrated that ruptured plaques are associated with higher stress compared to non-ruptured controls, with in vivo VH-IVUS studies linking higher plaque structural stress (PSS) with the presentation of acute coronary syndrome. Wall shear stress (WSS) on the other hand has been implicated in early plaque development and plaque growth suggesting that both PSS and WSS can influence future plaque behaviour. The work presented in this thesis is associated with a number of novel findings. First, it is the only work to demonstrate that in vivo PSS is higher in coronary atherosclerotic plaques with rupture vs. no rupture across a range of plaque subtypes and irrespective of whether analysis of the entire plaque or of regions close to the minimal luminal area is performed. Second, it shows that the pattern and extent of plaque progression and regression defined as an increase and decrease in plaque area, respectively, are associated with specific biomechanical environments at baseline, in the only study that examines the role of both PSS and WSS in this process. More specifically, high PSS is associated with changes consistent with increased vulnerability both in areas of progression and regression. On the other hand, lower WSS at baseline is associated with greater increases in plaque area and burden in areas that progress and with smaller decreases in areas that regress largely due to changes in fibrous tissue. Although the role of WSS in determining future plaque behaviour has been previously examined, this is the first time that this is assessed specifically in areas of progression and regression, particularly important in view of the dynamic nature of atherosclerotic plaques. More importantly, the work presented in this thesis demonstrates that the interplay of these biomechanical forces is associated with specific patterns of plaque progression and regression despite the fact that PSS and WSS are independent of each other. This has never been previously demonstrated and further suggests that incorporation of biomechanical analysis can play role in the identification of plaques that lead to future clinical events. Finally, the ability of PSS to identify plaques that lead to adverse clinical events was assessed through a propensity core matched analysis of the PROSPECT (A Prospective Natural-History Study of Coronary Atherosclerosis) study. The analysis presented here is the largest, most extensive and thus most significant work to ever examine this with results suggesting that incorporation of PSS and associated parameters can improve the capability of VH-IVUS to identify plaques that lead to such events. In summary, the results of this thesis suggest that coronary PSS plays an important role in the pathophysiology of plaque rupture, and that its incorporation in routine plaque assessment may improve our current ability to identifying coronary plaques that lead to future adverse clinical events. The interplay between PSS and WSS may also affect future plaque behaviour and in particular progression and regression. Prospective studies are now required to fully evaluate the role of these biomechanical forces in plaque development, and whether their incorporation in plaque evaluation can be of clinical significance.

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.

Em 2010, doenças cardiovasculares (CVD) causaram 33% do total das mortes no Brasil. O acúmulo de placas lipídicas, calcificadas e/ou fibrosas em vasos sanguíneos é chamado aterosclerose e é uma das principais causas da maioria das internações por doenças coronárias. A implantação de stent é um dos métodos mais comuns para o tratamento de pacientes com obstrução nas coronárias, mas este pode desencadear um crescimento de uma nova íntima e causar novamente o estreitamento do vaso, resultando em problemas de irrigação do coração. Alternativas como Tomografia por Coerência Óptica Intravascular (IOCT) oferecem imagens in vivo para detecção e monitoramento da progressão de CVDs. Adicionalmente, métodos computacionais aplicados a imagens IOCT podem fornecer dados objetivos de estruturas como áreas, perímetros, etc., permitindo mais precisão no diagnóstico. Contudo, ainda é pequena a variedade de métodos quantitativos aplicados a IOCT na literatura, em comparação a outras modalidades relacionadas. Neste trabalho é proposto um método para quantificação da neoíntima após a implantação de stent, fornecendo assim informações para possíveis tratamentos. Para isto são utilizadas imagens reais de IOCT de diferentes fontes: humanos, porcos e coelhos, adquiridas em diferentes períodos após a implantação do stent. Primeiro, é segmentada a parede do vaso (Lúmen), por meio da utilização de modulação de intensidade, filtragem, Fuzzy connectedness e binarização por limiar, seguida de um teste de Branch Opening e um conjunto de operações morfológicas. Segundo, o stent é identificado e segmentado, utilizando características extraídas de derivadas gerando imagens auxiliares à imagem de IOCT seguido pelo emprego de operações de seleção dos possíveis pontos pertencentes ao Stent. Tendo o lúmen e o stent segmentados, a área correspondente à neointima pode ser calculada, executando esse procedimento em imagens do mesmo local adquiridas em períodos diferentes. Assim pode ser feita a quantificação do crescimento de tecido. Para a avaliação do método, é comparada a área segmentada do lúmen e do stent, com os métodos propostos, com a área segmentada manualmente por especialistas (Gold Standard). / In 2010, cardiovascular disease (CVD) caused 33% of the total deaths in Brazil. The accumulation of lipidic, calcified and fibrous plaque, in the vessel wall is called atherosclerosis, and it is the main reason of most admissions in hospitals due to coronary heart disease. The stent implantation is one of the most common methods for coronary obstruction treatment, but this can trigger a neo-intima restenosis, and cause again narrowing of the vessel wall, resulting again in heart-irrigation problems. Modalities such as Intravascular Optical Coherent Tomography (IOCT) can be important for this kind of investigations, because it provides coronary in vivo for detecting and monitoring the progression of CVDs. Additionally, computational methods applied to IOCT images, can render objective structure information, such as areas, perimeters, etc., allowing for more accurate diagnosis. However, the variety of methods in the literature applied in IOCT is still small compared to other related modalities. Therefore, we propose a method for neointima restenosis quantification after stent implantation, thereby providing information to potential treatments. Consequently, we used real IOCT images from different sources: humans, pigs, and rabbits, acquired in different periods after stent implantation. First, the lumen is segmented by using intensity modulation and filtering, next fuzzy connectedness and thresholding is carried out, followed by a \"Branch Opening\" test and a set of morphological operations. Second, the stent is identified and segmented using extracted features by derivative operations, generating auxiliary images to the IOCT. Finally, a set of operations to identify and to select possible points which belong to Stent is performed. Having the lumen and stent segmented the area corresponding to the neo-intima can be calculated. By performing the same procedure in images acquired from the same location at different times, the ratio of the neointima growing can be computed. The evaluation is carried out by comparing the segmented new intima area between the proposed and manual method executed by specialist (Gold Standard).

Coronary atherosclerosis is by far the most frequent cause of ischemic heart disease. Intravascular ultrasound (IVUS) along with virtual histology (VH) is a useful tool for quantification of coronary plaque buildup and provides new insights into the diagnosis of coronary disease. Rupture of vulnerable plaque causing acute coronary syndromes, coronary remodeling maintaining lumen size and plaque phenotype revealing pathological severity are among the most important topics related to atherosclerosis. In this thesis, variations of IVUS-VH-derived thin-cap fibroatheroma (TCFA) definitions are proposed to evaluate the plaque rupture, which is further analyzed in a layered manner; statins effects on coronary remodeling are comprehensively assessed with the implementation of automated IVUS segmentation and registration of IVUS pullbacks based on baseline and 1-year followup datasets; plaque phenotypes are determined and analyzed morphologically and compositionally on segmental basis using the same serial datasets. In addition, our research involves another important coronary disease — coronary allograft vasculopathy (CAV) which is a frequent complication of heart transplantation (HTx). Another intra-coronary imaging modality — intravascular optical coherence tomography (IVOCT) for quantifying CAV is involved. We present an optimal and automated 3-D graph search approach for the simultaneous IVOCT multi-layer segmentation by transforming the 3-D segmentation problem into finding a minimum-cost closed set in a weighted graph. Furthermore, a computer-aided just-enough-interaction refinement method is proposed to help achieve fully satisfactory 3-D segmentation of IVOCT images. We believe this is the first work that provides a fast, efficient and accurate solution for IVOCT multi-layer assessment in the context of CAV. The major contributions of this thesis are: (1) Proving that IVUS-VH-derived TCFA prevalence may be overestimated, and elucidating the potential loss of plaque material during rupture, (2) providing a comprehensive understanding of remodeling in the context of both changing the remodeling direction and changing the remodeling extent, and demonstrating the statin therapy effects on remodeling across patients, based on automated segmentation of IVUS images and registration of serial data, (3) showing that the pathological intimal thickening is the most active plaque phenotype in terms of plaque composition changes and plaque vulnerability progression, and (4) developing and validating a method for multi-layer 3-D segmentation of IVOCT images within a novel interactive environment.

Submitted by (ana.araujo@ufrpe.br) on 2016-08-08T15:17:09Z No. of bitstreams: 1 Moacy Vasconcelos Cabral.pdf: 608103 bytes, checksum: 99d5c81824432310afaa742f16c76e41 (MD5) / Made available in DSpace on 2016-08-08T15:17:09Z (GMT). No. of bitstreams: 1 Moacy Vasconcelos Cabral.pdf: 608103 bytes, checksum: 99d5c81824432310afaa742f16c76e41 (MD5) Previous issue date: 2008-02-28 / There are several factors that are responsible for the most deaths caused by cardiovascular diseases, which are growing in almost all countries of the world. Acute myocardial infarction (AMI) is the one that occurs with the greatest extent, originating from the partial or total occlusion of one or more coronary arteries – the atherosclerosis. Throughout the years, various techniques were implemented to diagnose as well as to treat coronary diseases. In the search for a better quality of life and a less invasive treatment than the traditional surgeries for myocardial revascularization, angioplasty is applicable. Unfortunately, around 30% of the patients treated with angioplasty, in a period of just six months, come back to treatment due to restenosis – a reoccurrence of the narrowing or blockage in the blood vessel. Nowadays, Intravascular Brachytherapy – a technique with intravenous radiation – is the method of choice as it handles this phase in a satisfactory way, for it is observed the receding of the proliferative metabolism of restenosis. Thus, with the aim for radiological protection of both patients and professionals involved in the therapy, the distribution of doses for the monoenergetic electrons and photons were calculated for blood vessels of 4.5, 3.0 and 1.5 mm of diameter in several sources, using the MCNP4B code. In this context, the goal of this work was to classify theradioactive sources used in Intravascular Brachytherapy by employing Cluster Analyses with related dendograms and Cophenetic Correlation Coefficients. The results showed that the hierarchical techniques were effective in the classification of the electron-emitting radioactive sources (Cophenetic Correlation Coefficients varied from 0.81 to 0.99), whereas for the photons these techniques were not satisfactory (Cophenetic Correlation Coefficients varied from 0.64 to 0.78). / Existem vários fatores que são responsáveis pela grande maioria das mortes causadas por doenças cardiovasculares as quais são crescente em quase todos os países do mundo, sendo o infarto agudo do miocárdio (IAM) a que ocorre com maior destaque, oriundo de oclusão parcial ou total de uma ou mais artérias coronárias (a aterosclerose). Atualmente, vêm sendo aplicadas diversas técnicas tanto para diagnosticar quanto para tratar a doença coronariana. Buscando uma melhor qualidade de vida e um tratamento menos invasivo do que as tradicionais cirurgias de revascularização do miocárdio, emprega-se a angioplastia coronária. Lamentavelmente, em torno de 30% dos pacientes tratados por angioplastia, em um período de apenas seis meses, voltam ao médico devido à reestenose (reestreitamento da artéria). Recentemente, a braquiterapia intravascular (terapia com radiação intravaso) vem sendo bastante útil no retardo do metabolismo proliferativo da reestenose. Dessa forma, visando à proteção radiológica dos pacientes e profissionais envolvidos nesta terapia, cálculos de dose foram realizados em vasos sanguíneos de 4,5, 3,0 e 1,5 mm de diâmetro para diversas fontes de radiação,usando o código MCNP4B. Neste contexto, o objetivo do presente trabalho foi o de classificar fontes radioativas usadas na Braquiterapia Intravascular utilizando a análise de agrupamento, por meio de dendograma e Correlação Cofenética associados. Os resultados mostraram que as técnicas hierárquicas foram eficientes na classificação das fontes radioativas emissoras de elétrons (as Correlações Cofenéticas variaram de 0,81 a 0,99), enquanto que para os fótons essas técnicas não foram satisfatórias (as Correlações Cofenéticas variaram de 0,64 a 0,78).

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.