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2.
Arq. bras. cardiol ; 106(6): 541-543, graf
Article in English | LILACS | ID: lil-787324

ABSTRACT

Abstract We describe the treatment of a patient presenting with very-late stent thrombosis with the use of a drug-coated balloon. In this patient, optical coherence tomography disclosed that ruptured and complicated neoatherosclerosis was the underlying substrate responsible for the episode of very-late stent thrombosis. The potential use of drug-coated balloons in this unique scenario is discussed.


Resumo Descrevemos o tratamento de um paciente apresentando trombose de stent muito tardia com a utilização de um balão farmacológico. Nesse paciente, a tomografia de coerência ótica revelou que a neoaterosclerose apresentava-se complicada e com ruptura, sendo portanto o substrato subjacente responsável pelo episódio de trombose de stent muito tardia. O uso potencial de balões farmacológicos nesse cenário especial é discutido.


Subject(s)
Humans , Male , Middle Aged , Coronary Thrombosis/therapy , Angioplasty, Balloon , Coronary Restenosis/therapy , Atherosclerosis/complications , Drug-Eluting Stents/adverse effects , Coronary Thrombosis/etiology , Coronary Restenosis/etiology , Coronary Restenosis/diagnostic imaging
3.
Arch. cardiol. Méx ; 84(4): 305-309, oct.-dic. 2014. ilus
Article in Spanish | LILACS | ID: lil-744052

ABSTRACT

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


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


Subject(s)
Humans , Male , Middle Aged , Coronary Restenosis/diagnosis , Coronary Restenosis/surgery , Coronary Thrombosis/diagnosis , Coronary Thrombosis/surgery , Drug-Eluting Stents , Prosthesis Failure , Tomography, Optical Coherence , Coronary Restenosis/etiology , Coronary Thrombosis/etiology , Surgery, Computer-Assisted
4.
Article in English | IMSEAR | ID: sea-162162

ABSTRACT

Background: Dilated cardiomyopathy is associated by radial and longitudinal contractile cardiac dysfunction. Left ventricular (LV) thrombus is a frequent finding in patients with dilated cardiomyopathy. The main purpose of our study was to evaluate the role of mitral annular plane systolic excursion (MAPSE) in LV thrombus formation in patients with dilated cardiomyopathy by assessing their correlation. Our additional objective was to compare the relationship of average MAPSE to relations of other LV features [LV size, LV ejection fraction (EF), wall motion score index (WMSI), sphericity index-width to length ratio (w/l) of the LV] and LV thrombus development. Material and Methods: This was a prospective cross-sectional study conducted from October 2009 until January 2012 in 100 sinus rhythm patients with dilated cardiomyopathy without anticoagulation therapy. We excluded patients with: swallowing problems, acute myocardial infarction, atrial fibrillation/flutter, severe systolic dysfunction, severe arterial hypertension, valvular disease, and/or mechanical valves. Results: Mean patient age was 58.1±12.7 years and 69% were men. Mean LV EF was 39.1±6.4%, while mean value of average MAPSE was 9.3±2.2mm. LV thrombus was detected in 14% of patients and its presence correlated well with: average MAPSE (r=-0.22, p=0.01), MAPSE of sepatal wall (r=-0.23, p=0.01), MAPSE of lateral wall (r=-0.2, p=0.02), MAPSE of inferior wall (r=-0.22, p=0.01), LV EF (r=-0.21, p=0.02), LV end diastolic diameter (r=0.24, p=0.008), LV end systolic diameter (r=0.31, p=0.0008), WMSI (r=0.22, p=0.01) and w/l (r=0.19, p=0.03). Conclusions: Longitudinal LV dysfunction is associated with LV thrombus formation, as average MAPSE demonstrates a negative correlation with LV thrombus, and its role is similar to LV size, LV EF, sphericity index and WMSI.


Subject(s)
Aged , Coronary Thrombosis/etiology , Female , Heart Ventricles , Humans , Male , Middle Aged , Mitral Valve/physiopathology , Thrombosis/etiology
5.
Arq. bras. cardiol ; 103(3): 174-182, 09/2014. tab, graf
Article in English | LILACS | ID: lil-723823

ABSTRACT

Background: Drug-eluting stents have been used in daily practice since 2002, with the clear advantages of reducing the risk of target vessel revascularization and an impressive reduction in restenosis rate by 50%-70%. However, the occurrence of a late thrombosis can compromise long-term results, particularly if the risks of this event were sustained. In this context, a registry of clinical cases gains special value. Objective: To evaluate the efficacy and safety of drug-eluting stents in the real world. Methods: We report on the clinical findings and 8-year follow-up parameters of all patients that underwent percutaneous coronary intervention with a drug-eluting stent from January 2002 to April 2007. Drug-eluting stents were used in accordance with the clinical and interventional cardiologist decision and availability of the stent. Results: A total of 611 patients were included, and clinical follow-up of up to 8 years was obtained for 96.2% of the patients. Total mortality was 8.7% and nonfatal infarctions occurred in 4.3% of the cases. Target vessel revascularization occurred in 12.4% of the cases, and target lesion revascularization occurred in 8% of the cases. The rate of stent thrombosis was 2.1%. There were no new episodes of stent thrombosis after the fifth year of follow-up. Comparative subanalysis showed no outcome differences between the different types of stents used, including Cypher®, Taxus®, and Endeavor®. Conclusion: These findings indicate that drug-eluting stents remain safe and effective at very long-term follow-up. Patients in the "real world" may benefit from drug-eluting stenting with excellent, long-term results. .


Fundamento: Stents eluidores de drogas têm sido utilizados na prática médica desde 2002, e apresentam grande eficácia na redução do risco de revascularização do vaso-alvo, e notável redução da taxa de reestenose de 50%-70%. No entanto, a ocorrência de trombose tardia pode comprometer os resultados a longo prazo, especialmente se o risco de trombose for mantido ao longo dos anos. Neste contexto, o registro da prática clínica assume grande importância. Objetivo: Avaliar a eficácia e segurança de stents eluidores de drogas no mundo real. Métodos: Relatamos os resultados de todos os pacientes que foram submetidos à intervenção coronária percutânea com stent eluidor de drogas no período entre janeiro de 2002 a abril de 2007, e que foram acompanhados por 8 anos. Os stents eluidores de drogas foram utilizados de acordo com as recomendações clínicas do cardiologista intervencionista e a disponibilidade do stent. Resultados: Um total de 611 pacientes foram avaliados, com acompanhamento clínico de 96,2% destes pacientes por até 8 anos. A mortalidade total foi de 8,7%. Infarto não-fatal ocorreu em 4,3% dos casos. A taxa de revascularização do vaso-alvo foi de 12,4% e a da lesão-alvo foi de 8,0%. A taxa de trombose de stent foi de 2,1%. Não houve novos episódios de trombose de stent após o quinto ano de acompanhamento. Uma subanálise comparativa indicou não haver diferenças nos desfechos clínicos apos a utilização dos stents Cypher, Taxus e Endeavor. Conclusão: Estes resultados indicam que stents eluidores de drogas são seguros e eficazes em acompanhamentos de longo prazo, e que pacientes no mundo real podem beneficiar destes stents, com excelentes resultados a longo prazo. .


Subject(s)
Aged , Female , Humans , Drug-Eluting Stents/adverse effects , Percutaneous Coronary Intervention/methods , Coronary Angiography , Coronary Artery Disease/surgery , Coronary Thrombosis/etiology , Follow-Up Studies , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Risk Factors , Statistics, Nonparametric , Time Factors , Treatment Outcome
6.
Arq. bras. cardiol ; 102(6): 529-538, 06/2014. tab, graf
Article in English | LILACS | ID: lil-712921

ABSTRACT

Background: Long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain uncertain. Objective: To investigate long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI). Methods: We performed search of MEDLINE, EMBASE, the Cochrane library, and ISI Web of Science (until February 2013) for randomized trials comparing more than 12-month efficacy or safety of DES with BMS in patients with STEMI. Pooled estimate was presented with risk ratio (RR) and its 95% confidence interval (CI) using random-effects model. Results: Ten trials with 7,592 participants with STEMI were included. The overall results showed that there was no significant difference in the incidence of all-cause death and definite/probable stent thrombosis between DES and BMS at long-term follow-up. Patients receiving DES implantation appeared to have a lower 1-year incidence of recurrent myocardial infarction than those receiving BMS (RR = 0.75, 95% CI 0.56 to 1.00, p= 0.05). Moreover, the risk of target vessel revascularization (TVR) after receiving DES was consistently lowered during long-term observation (all p< 0.01). In subgroup analysis, the use of everolimus-eluting stents (EES) was associated with reduced risk of stent thrombosis in STEMI patients (RR = 0.37, p=0.02). Conclusions: DES did not increase the risk of stent thrombosis in patients with STEMI compared with BMS. Moreover, the use of DES did lower long-term risk of repeat revascularization and might decrease the occurrence of reinfarction. .


Fundamento: Os resultados a longo prazo dos stents farmacológicos (SF) contra stents convencionais (SC) em pacientes com infarto do miocárdio com elevação do segmento ST (IMEST) permanecem incertos. Objetivo: Investigar os resultados a longo prazo dos stents farmacológicos (SF) contra stents convencionais (SC) em pacientes com infarto do miocárdio com elevação do segmento ST (IMEST) . Métodos: Foi realizada pesquisa de dados nas bases de dados MEDLINE, EMBASE, na Cochrane Library, e na ISI Web of Science (até fevereiro de 2013) para estudos clínicos aleatórios que comparam a eficácia durante mais de 12 meses ou a segurança do SF com SC em pacientes com IMEST. Foi apresentada uma estimativa agrupada com risco relativo (RR) e seu intervalo de confiança de 95 % (IC), utilizando modelo de efeitos aleatórios. Resultados: Dez estudos com 7.592 participantes com IMEST foram incluídos. Os resultados gerais mostraram que não houve diferença significativa na incidência de morte por todas as causas e trombose de stent definida/provável entre SF e SC em seguimento de longo prazo. Os pacientes que receberam implante de SF pareciam ter uma incidência de infarto do miocárdio recorrente inferior a1 ano que aqueles que receberam SC (RR = 0,75, 95% CI 0,56-1,00, p = 0,05). Além disso, o risco de revascularização do vaso alvo (RVA) depois de receber o SF diminui consistentemente durante a observação a longo prazo (todos p <0,01). Na análise de subgrupo, o uso de stents com eluição de everolimus (EEE) foi associado a um risco reduzido de trombose de stent em pacientes IMEST (RR = 0,37, p = 0,02). Conclusões: SF não aumentou o risco de trombose de stent em pacientes com IMEST em comparação com SC. Além disso, o uso de SF fez baixar o risco de longo prazo de repetição ...


Subject(s)
Female , Humans , Male , Middle Aged , Drug-Eluting Stents , Myocardial Infarction/therapy , Stents , Coronary Thrombosis/etiology , Drug-Eluting Stents/adverse effects , Metals , Myocardial Infarction/physiopathology , Odds Ratio , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , Stents/adverse effects , Time Factors , Treatment Outcome
8.
Rev. chil. cardiol ; 32(3): 196-203, 2013. ilus, tab
Article in Spanish | LILACS | ID: lil-705222

ABSTRACT

Introducción: La principal ventaja de las bioprótesis es no requerir tratamiento anticoagulante. Sin embargo, algunas guías de manejo clínico recomiendan este tratamiento los primeros meses post cirugía. En los últimos años varios autores han demostrado la seguridad del uso exclusivo de aspirina en los primeros 3 meses después del reemplazo valvular aórtico con bioprótesis. Objetivo: Evaluar la morbimortalidad y complicaciones trombo embólicas y hemorrágicas en pacientes sometidos a reemplazo valvular aórtico (RVA) con bioprótesis tratados exclusivamente con aspirina (100 mg) los primeros tres meses post cirugía. Métodos: Estudio retrospectivo de 229 pacientes (137 hombres. edad 65,3 +/- 11,76 años) operados de RVA con bioprótesis entre junio 2006 y diciembre 2011. Hubo 178 cirugías aisladas y 51 combinadas y 20 pacientes tenían endocarditis. Se estudió la morbimortalidad, complicaciones trombo embólicas y sangrado a 30 y 90 días y en el seguimento alejado hasta el 30 de junio de 2012. Resultados: A 30 días hubo 4 accidentes cerebrovasculares, 3 accidentes isquémicos transitorios y una isquemia mesentérica. Fallecieron 8 pacientes (3,5 por ciento). A los 90 días hubo 2 hemorragias (1 hemorragia digestiva, 1 hemotórax), no hubo nuevos eventos trombo embólicos ni otros fallecidos. El seguimiento promedio fue 27.8+/-17,7 meses (rango 6 - 72 meses). Durante el seguimiento fallecieron 17 pacientes y no se registraron eventos trombo embólicos ni hemorrágicos. Conclusión: En pacientes operados de reemplazo valvular aórtico con bioprótesis el uso exclusivo de aspirina fue seguro para prevenir complicaciones trombo embólicas.


Background: The abscense of a need for anticoagulant therapy is a significant advantage of biologic valve prosthesis. However, according to some clinical guidelines conventional anti-coagulant therapy is recommended for the initial 3 months following aortic valve replacement. Aim: The aim of this study was to evaluate morbi-mortality and thrombo-embolic events in patients undergoing aortic valve replacement with a bioprosthesis receiving aspirin during the first 3 months after surgery. Methods: Data on 229 patients (137 males), aged 65.3+/-11.8 years who received biologic aortic valve prosthesis between June 2006 and December 2011 was retrospectively analyzed. 51 patients underwent combined (coronary and/or mitral valve surgery) and 20 patients had infectious endocarditis. Morbidity, mortality, thrombo-embolic and hemorrhagic events were tabulated up to June 30, 2012. Results: During the first 30 days after surgery there were 4 cerebro-vascular events and 1 episode of mesenteric ischemia. Operative (30 day) mortality was 3.5 percent (8 patients). At 90 days, 2 patients had a hemorrhagic event (GI bleeding and hemotho-rax, respectively), but no further embolic events or deaths occurred. Patients were followed for a mean of 27.8 +/-17,7 months (range 6 to 72 months). 17 patients died but no cases of embolism or bleeding were observed. Conclusion: Aspirin was safe and effective for prevention of thrombo-embolic complications following aortic valve replacement with a biologic prosthesis.


Subject(s)
Humans , Male , Female , Middle Aged , Anticoagulants/therapeutic use , Aspirin/therapeutic use , Heart Valve Prosthesis , Coronary Thrombosis/prevention & control , Coronary Thrombosis/etiology
9.
The Korean Journal of Internal Medicine ; : 72-80, 2013.
Article in English | WPRIM | ID: wpr-108741

ABSTRACT

BACKGROUND/AIMS: The Taxus Liberte stent (Boston Scientific Co.) evolved from the Taxus Express stent, with enhanced stent deliverability and uniform drug delivery. This study was designed to compare angiographic and clinical outcomes in real-world practice between the Taxus Liberte and Taxus Express stents. METHODS: Between 2006 and 2008, 240 patients receiving the Taxus Liberte stent at three centers were registered and compared to historical control patients who had received the Taxus Express stent (n = 272). After propensity score matching, 173 patients treated with the Taxus Liberte stent and the same number of patients treated with the Taxus Express stent were selected. The primary outcome was a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), ischemia driven target vessel revascularization (TVR), and stent thrombosis (ST) at 1 year. An additional angiographic assessment was conducted at 9 to 12 months. RESULTS: The study showed no significant difference between the Taxus Express and Taxus Liberte stents (death, 1.73% vs. 2.31%, p = 1.000; MI, 0% vs. 1.73%, p = 0.2478; TVR, 2.31% vs. 1.16%, p = 0.6848; and ST, 0% vs. 1.16%, p = 0.4986). The total MACE rate at 1 year did not differ between the groups (4.05% in Taxus Express vs. 4.05% in Taxus Liberte, p = 1.000). In addition, the binary restenosis rate did not differ (2.25% in Taxus Express vs. 1.80% in Taxus Liberte, p = 0.6848). CONCLUSIONS: In real-world experience with the two Taxus stent designs, both stents showed similarly good clinical and angiographic outcomes at 1 year. A long-term follow-up study is warranted.


Subject(s)
Aged , Female , Humans , Male , Middle Aged , Angioplasty, Balloon, Coronary/adverse effects , Cardiovascular Agents/administration & dosage , Chi-Square Distribution , Coronary Angiography , Coronary Artery Disease/mortality , Coronary Restenosis/etiology , Coronary Thrombosis/etiology , Drug-Eluting Stents , Myocardial Infarction/etiology , Paclitaxel/administration & dosage , Propensity Score , Prosthesis Design , Registries , Republic of Korea , Retrospective Studies , Risk Factors , Stainless Steel , Time Factors , Treatment Outcome
10.
Arq. bras. cardiol ; 98(4): e66-e69, abr. 2012. ilus
Article in Portuguese | LILACS | ID: lil-639427

ABSTRACT

A síndrome do anticorpo antifosfolípide (SAF) é uma trombofilia autoimune, caracterizada pela presença de anticorpos plasmáticos contra fosfolípides, associada a episódios recorrentes de trombose venosa e/ou arterial e morbidade gestacional (especialmente abortamento de repetição). Reportamos o caso de uma paciente feminina, jovem, com diagnóstico de lúpus eritematoso sistêmico (LES), associado à presença de anticorpos antifosfolípide de longa data, com apresentação de infarto agudo do miocárdio (IAM) por trombose proximal da artéria descendente anterior como primeira complicação clínica da SAF.


The antiphospholipid syndrome (APS) is an autoimmune thrombophilia, characterized by the presence of plasma antibodies against phospholipids, associated with recurrent episodes of venous and/or arterial thrombosis and gestational morbidity (especially recurrent miscarriage). We report the case of a young female patient diagnosed with systemic lupus erythematosus (SLE) associated with the presence of antiphospholipid antibodies for a long time, presenting with acute myocardial infarction (AMI) due to proximal thrombosis of the anterior descending artery as the first clinical complication of APS.


El Síndrome del Anticuerpo Antifosfolípido (SAF), es una trombofilia autoinmune, caracterizada por la presencia de anticuerpos plasmáticos contra fosfolípidos, asociada a episodios recurrentes de trombosis venosa y/o arterial y morbilidad gestacional (especialmente aborto de repetición). Reportamos aquí, el caso de una paciente del sexo femenino, joven, con diagnóstico de lupus eritematoso sistémico (LES), asociado a la presencia de anticuerpos antifosfolípido hacía ya mucho tiempo, presentando infarto agudo del miocardio (IAM), por trombosis proximal de la arteria descendente anterior como primera complicación clínica de la SAF.


Subject(s)
Adult , Female , Humans , Antiphospholipid Syndrome/complications , Coronary Thrombosis/etiology , Lupus Erythematosus, Systemic/complications , Myocardial Infarction/diagnosis , Treatment Outcome
12.
Arq. bras. cardiol ; 93(6): 590-597, dez. 2009. tab
Article in English, Spanish, Portuguese | LILACS | ID: lil-542739

ABSTRACT

Fundamento: Descrevemos as bases teóricas e o formato do "Estudo PAINT - Intervenção percutânea com stents com eluição de paclitaxel ou sirolimus em polímero biodegradável comparados com stents sem recobrimento no tratamento de lesões coronárias de novo". Objetivo: Avaliar duas novas formulações de stents com eluição de paclitaxel ou sirolimus em comparação com um stent de estrutura metálica idêntica, porém sem recobrimento polimérico ou eluição de droga. Métodos: O PAINT é um estudo randomizado, multicêntrico, de 3 braços, conduzido em centros terciários brasileiros, que incluiu 275 pacientes alocados para tratamento com os stents InfinniumR (paclitaxel), the SupralimusR (sirolimus) ou Milennium MatrixR (sem recobrimento) na proporção 2:2:1 ratio. Os pacientes apresentavam lesões coronarianas de novo em vasos nativos com um diâmetro entre 2,5 e 3,5 mm, passíveis de tratamento com um único stent com comprimento de 29 mm ou menos. O objetivo primário era comparar a perda tardia aos nove meses de ambos stents com paclitaxel- ou sirolimus versus a perda luminal dos stents convencionais de controle. Objetivos secundários importantes incluíam a comparação angiográfica entre os dois tipos de stents farmacológicos, bem como a análise da ocorrência de eventos clínicos adversos. Resultados e conclusões: O estudo PAINT apresenta um formato peculiar e único que permitiu a avaliação da segurança e eficácia de duas novas formulações de stents farmacológicos, com carreador polimérico biodegradável, e liberação de paclitaxel ou sirolimus, os quais foram comparados contra um stent metálico convencional (objetivo primário). Uma vez que os stents farmacológicos diferiram entre sí somente pela droga, mas eram idênticos nas suas outras características, os estudo também permitiu a comparação do efeito anti-restenótico entre sirolimus e paclitaxel (objetivo secundário).


Background: We describe the rationale and design for the "PercutAneous Intervention with biodegradable-polymer based paclitaxel-eluting or sirolimus-eluting versus bare stents for de novo coronary lesions - PAINT trial". Objectives: To evaluate two novel formulations of paclitaxel-eluting stent and the sirolimus-eluting stent against a stent with the same metallic structure but without polymer coating or drug elution. Methods: The PAINT is a multicenter 3-arm randomized trial, conducted in Brazilian tertiary institutions, which included 275 patients allocated for the InfinniumR paclitaxel-eluting stent, the SupralimusR sirolimus-eluting stent or the Milennium MatrixR bare metal stent in a 2:2:1 ratio. Patients had de novo coronary lesions in native vessels with a diameter between 2.5 and 3.5 mm, amenable for treatment with a single stent of 29 mm or less in length. The primary objetive was to compare the in-stent late loss at 9 months of both paclitaxel- and sirolimus-eluting versus the late loss of control bare metal stents. Important secondary objectives included the comparison in outcomes between sirolimus and paclitaxel stents, as well as the analysis of the incidence of major adverse cardiac events. Results amd conclusions: The PAINT trial had a unique design that allowed for the evaluation of the safety and efficacy profiles of two novel drug-eluting stent formulations, with a biodegradable-polymer carrier and releasing paclitaxel or sirolimus, which were compared against a bare metal stent (primary objective). As the drug-eluting stents differed by the drug, but were identical otherwise, the trial also allowed the comparison of the anti-restenosis effects of sirolimus versus paclitaxel (secondary objective).


Fundamento: Describimos las bases teóricas y el formato del "Estudio PAINT - Intervención percutánea con stents recubiertos de paclitaxel o sirolimus en polímero biodegradable comparados con stents no recubiertos en el tratamiento de lesiones coronarias de novo". Objetivo: Evaluar dos nuevas formulaciones de stents con liberación de paclitaxel o sirolimus en comparación con un stent de estructura metálica idéntica, pero sin recubierto polimérico o liberación de droga. Métodos: El PAINT es un estudio randomizado, multicéntrico, de 3 brazos, llevado a cabo en centros terciaros brasileños, que incluyó a 275 pacientes destinados a tratamiento con los stents InfinniumR (paclitaxel), the SupralimusR (sirolimus) o Milennium MatrixR (no recubierto) en la proporción 2:2:1. Los pacientes presentaban lesiones coronarias de novo en vasos nativos con un diámetro entre 2,5 y 3,5 mm, pasibles de tratamiento con un único stent de hasta 29 mm de longitud. El objetivo primario era comparar la pérdida luminal tardía a los nueve meses de ambos stents con paclitaxel- o sirolimus versus la pérdida luminal de los stents convencionales de control. Los objetivos secundarios importantes incluían la comparación angiográfica entre los dos tipos de stents farmacológicos, así como el análisis de la ocurrencia de eventos clínicos adversos. Resultados y conclusiones: El estudio PAINT presenta un formato peculiar y único que permitió la evaluación de la seguridad y eficacia de dos nuevas formulaciones de stents farmacológicos, con transportador polimérico biodegradable, y liberación de paclitaxel o sirolimus, los que fueron comparados con un stent metálico convencional (objetivo primario). Dado que los stents farmacológicos diferían entre sí solamente por la droga, pero eran idénticos en sus otras características, el estudio también permitió la comparación del efecto antireestenótico entre sirolimus y paclitaxel (objetivo secundario).


Subject(s)
Adolescent , Humans , Young Adult , Angioplasty, Balloon, Coronary/instrumentation , Coronary Disease/therapy , Drug-Eluting Stents , Paclitaxel/administration & dosage , Polymers/chemistry , Sirolimus/administration & dosage , Absorbable Implants , Angioplasty, Balloon, Coronary/methods , Brazil/epidemiology , Cardiovascular Agents/administration & dosage , Coronary Disease/pathology , Coronary Restenosis/prevention & control , Coronary Thrombosis/epidemiology , Coronary Thrombosis/etiology , Drug-Eluting Stents/adverse effects , Epidemiologic Methods , Prosthesis Design , Treatment Outcome , Young Adult
13.
Indian Heart J ; 2008 May-Jun; 60(3): 228-32
Article in English | IMSEAR | ID: sea-3738

ABSTRACT

OBJECTIVE: To evaluate the performance of a biodegradable polymer based rapamycin-eluting coronary stent in a porcine model and demonstrate its safety and efficacy in the treatment of patients with de novo coronary stenosis. BACKGROUND: The indefinite presence of the polymer after the implantation of drug-eluting stents may initiate and sustain inflammation and contribute to the occurrence of late complications. METHODS: Seven study stents and 5 polymer-coated (control) stents were implanted in porcine carotid arteries. Histomorphometric analysis was performed 8 weeks after stent implantation. After establishing the safety of the stent in the animal model, a single-center, non-randomized study in patients with de novo coronary artery lesions was performed. Forty-nine stents were implanted in 43 patients. The 6-month clinical follow-up was 91% (39/43) and angiographic follow-up was 67% (29/43). The primary safety endpoint was the occurrence of 30-day major adverse cardiovascular events (MACE) and the principal efficacy endpoint was the 6-month angiographic late loss and binary restenosis rate. RESULTS: In the porcine model, the study stent showed acceptably low injury, inflammation and fibrin scores. There was a quantitative reduction in neointimal hyperplasia which was not statistically different from the control stent. However, in the first-in-man evaluation, there was significant suppression of intimal growth as evidenced by an angiographic late loss of 0.28 +/- 0.45 mm at 6 months. The restenosis rate was 10.3% (3/297). There was no death, stent thrombosis or myocardial infarction at 30 days or at 6 months. The 6-month target lesion revascularization rate was 3.47 percent; (1/29). CONCLUSION: This preclinical and early clinical experience demonstrates the safety and efficacy of a novel biodegradable polymer-based rapamycin-eluting coronary stent.


Subject(s)
Absorbable Implants , Animals , Aspirin/therapeutic use , Coronary Restenosis/drug therapy , Coronary Thrombosis/etiology , Drug-Eluting Stents/adverse effects , Humans , Immunosuppressive Agents/adverse effects , India , Inflammation/prevention & control , Models, Animal , Platelet Aggregation Inhibitors/therapeutic use , Polymers , Risk Factors , Sirolimus/adverse effects , Ticlopidine/analogs & derivatives , Time Factors
15.
Rev. bras. cardiol. invasiva ; 15(2): 164-166, abr.-jun. 2007. ilus
Article in Portuguese | LILACS | ID: lil-452018

ABSTRACT

A trombose tardia nos stents revestidos com drogas antiproliferativas é uma realidade a ser enfrentada. Ela ocorre com maior frequência dependendo do critério de trombose, do que em stents convencionais. A trombose pode se dar anos após o implante e mesmo em pacientes usando antiagregante plaquetário. O desfecho clínico pode ser dramático, entretanto, não sabemos ainda se este evento realmente aumenta a mortalidade, quando comparado ao stent convencional. Os autores relatam um caso de trombose de stent Cypher, quase quatro anos após o seu implante.


A trombose tardia nos stents revestidos com drogas antiproliferativas é uma realidade a ser enfrentada. Ela ocorre com maior freqüência, dependendo do critério de trombose, do que em stents convencionais. A trombose pode se dar anos após o implante e mesmo em pacientes usando antiagregante plaquetário. O desfecho clínico pode ser dramático, entretanto, não sabemos ainda se este evento realmente aumenta a mortalidade, quando comparado ao stent convencional. Os autores relatam um caso de trombose de stent Cypher, quase quatro anos após o seu implante.


Subject(s)
Humans , Male , Middle Aged , Stents , Coronary Restenosis/surgery , Coronary Restenosis/complications , Coronary Thrombosis/surgery , Coronary Thrombosis/etiology , Paclitaxel/adverse effects , Sirolimus/administration & dosage , Sirolimus/agonists
16.
Arq. bras. cardiol ; 88(5): e111-e114, maio 2007. ilus
Article in Portuguese | LILACS | ID: lil-453059

ABSTRACT

Homem de 39 anos com angina pós-infarto. Coronariografia demonstrou: obstrução total proximal da artéria coronária direita (ACD), lesões obstrutivas de 95 por cento na artéria descendente anterior (ADA), 80 por cento no 2° ramo marginal esquerdo (ME) e 95 por cento na artéria circunflexa (ACX). O paciente foi submetido a implante de stent TAXUS 3,0 x 24 mm e stent EXPRESS 2,75 x 24 mm nos terços proximal e distal da ACD, respectivamente, e stent INFINNIUM 3,0 x 24 mm na ADA com sucesso. Após 7 meses, apresentou IAM anterior por trombose do stent INFINNIUM e reestenose do stent TAXUS, sem perda de resultado nos stents convencionais.


A male 39 year-old patient with post-infarction angina. The coronary angiography showed total proximal obstruction of right coronary artery (RCA), obstructive lesions of 95 percent of the anterior descending artery (ADA), 80 percent of the second left marginal branch (LM2), and 95 percent of the circumflex artery (CXA). The patient was successfully implanted with a Taxus 3.0 x 24 mm stent and an Express 2.75 x 24 mm stent in the proximal and distal thirds of the RCA, respectively, and with an Infinnium 3.0 x 24 mm stent in the ADA. After seven months, the patient had an anterior acute myocardial infarct (AMI) due to thrombosis of the Infinnium stent and restenosis of the Taxus stent, with no loss of results in the conventional stents.


Subject(s)
Adult , Humans , Male , Angioplasty, Balloon, Coronary/adverse effects , Coronary Stenosis/therapy , Coronary Thrombosis/etiology , Paclitaxel/administration & dosage , Stents/adverse effects , Antineoplastic Agents, Phytogenic/administration & dosage , Coronary Angiography , Coronary Restenosis , Coronary Thrombosis/diagnosis , Drug-Eluting Stents/adverse effects , Treatment Outcome
17.
Indian Heart J ; 2007 Mar-Apr; 59(2 Suppl B): B41-9
Article in English | IMSEAR | ID: sea-4883

ABSTRACT

BACKGROUND: Polymer-based sirolimus (Cypher) and paclitaxel (Taxus) drug-eluting stents (DES) have become the treatment of choice for patients with symptomatic coronary artery disease. While these stents have reduced rates of restenosis and target lesion revascularization compared with bare metal stents (BMS), late thrombosis [i.e. stent thrombosis occurring > 30 days after percutaneous coronary intervention (PCI)], an often life-threatening complication, has emerged as a major safety concern. METHODS AND RESULTS: Using human pathological data, we have demonstrated that the current generation US Food and Drug Administration (FDA) Cypher and Taxus DES cause substantial impairment of arterial healing, defined as impaired re-endothelialization, persistent fibrin deposition, and absence or focal presence of smooth muscle cells covering the stent struts compared with BMS. This delay in healing constitutes the most important pathological substrate underlying cases of late DES thrombosis. CONCLUSIONS: This review will focus on the effects of these vascular implants in both animals and humans, especially as they relate to the process of late-stent thrombosis. We will use these data to make practical recommendations regarding anatomic and lesion considerations that may help the interventionalist to minimize the late thrombotic risk of these devices.


Subject(s)
Coronary Restenosis/pathology , Coronary Stenosis/pathology , Coronary Thrombosis/etiology , Drug-Eluting Stents/adverse effects , Equipment Safety , Humans , Paclitaxel/administration & dosage , Sirolimus/administration & dosage , Wound Healing/physiology
20.
Indian J Exp Biol ; 2007 Jan; 45(1): 103-10
Article in English | IMSEAR | ID: sea-60031

ABSTRACT

Atherothrombotic vascular disease is a complex disorder in which inflammation and coagulation play a pivotal role. Rupture of high-risk, vulnerable plaques with the subsequent tissue factor (TF) exposure is responsible for coronary thrombosis, the main cause of unstable angina, acute myocardial infarction, and sudden cardiac death. Tissue factor (TF), the key initiator of coagulation is an important modulator of inflammation. TF is widely expressed in atherosclerotic plaques and found in macrophages, smooth muscle cells, extracellular matrix and acellular lipid-rich core. TF expression can be induced by various stimulants such as C-reactive protein, oxLDL, hyperglycemia and adipocytokines. The blood-born TF encrypted on the circulating microparticles derived from vascular cells is a marker of vascular injury and a source of procoagulant activity. Another form of TF, called alternatively spliced has been recently identified in human and murine. It is soluble, circulates in plasma and initiates coagulation and thrombus propagation. Evidence indicates that elevated levels of blood-borne or circulating TF has been associated with metabolic syndrome, type 2 diabetes and cardiovascular risk factors and is a candidate biomarker for future cardiovascular events. Therapeutic strategies have been developed to specifically interfere with TF activity in the treatment of cardiovascular disease.


Subject(s)
Coronary Artery Disease/etiology , Coronary Thrombosis/etiology , Diabetes Mellitus/metabolism , Endothelium, Vascular/metabolism , Humans , Hyperglycemia/complications , Inflammation/complications , Obesity/complications , Thromboplastin/genetics
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