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1.
Diabetes Res Clin Pract ; 127: 275-284, 2017 May.
Article in English | MEDLINE | ID: mdl-28412543

ABSTRACT

AIMS: The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country. METHODS: REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke). RESULTS: A total of 5006 subjects was included and analyzed in four groups: No diabetes and no previous cardiovascular event, n=430; diabetes and no previous cardiovascular event, n=1138; no diabetes and previous cardiovascular event, n=1747; and diabetes and previous cardiovascular event, n=1691. Major clinical events in one-year follow-up occurred in 332 patients. A previous cardiovascular event was associated with a higher risk of having another event in the follow-up (HR 2.31 95% CI 1.74-3.05, p<0.001), as did the presence of diabetes (HR 1.28 95% CI 1.10-1.73, p=0.005). In patients with diabetes,failure to reach HbA1c targetswas related topoorer event-free survival compared to patients with good metabolic control (HR 1.70 95% CI 1.01-2.84, p=0.044). CONCLUSIONS: In Brazil, diabetes confers high risk for major clinical events, but this condition is not equivalent to having a previous cardiovascular event. Moreover, not so strict targets for HbA1c in patients with diabetes and previous cardiovascular events might be considered.


Subject(s)
Cardiovascular Diseases/etiology , Diabetes Mellitus, Type 2/etiology , Brazil , Cardiovascular Diseases/mortality , Cardiovascular Diseases/pathology , Diabetes Mellitus, Type 2/mortality , Diabetes Mellitus, Type 2/pathology , Female , Humans , Male , Middle Aged , Registries , Risk Factors , Social Class
2.
Diabetes Res Clin Pract ; 127: 275-284, 2017. tab, ilus
Article in English | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1062383

ABSTRACT

AIMS:The aim of this study was to determine the rate of major clinical events and its determinants in patients with previous cardiovascular event or not, and with or without diabetes from a middle-income country.METHODS:REACT study is a multicenter registry conducted between July 2010 and May 2013 in Brazil. Patients were eligible if they were over 45years old and high cardiovascular risk. Patients were followed for 12months; data were collected regarding adherence to evidence-based therapies and occurrence of clinical events (all-cause mortality, non-fatal cardiac arrest, myocardial infarction, or stroke).


Subject(s)
Humans , Male , Female , Middle Aged , Diabetes Mellitus/etiology , Diabetes Mellitus/mortality , Diabetes Mellitus/pathology , Cardiovascular Diseases/etiology , Cardiovascular Diseases/mortality , Cardiovascular Diseases/pathology
5.
Int J Cardiovasc Imaging ; 27(6): 867-74, 2011 Jul.
Article in English | MEDLINE | ID: mdl-21082255

ABSTRACT

Despite the expressive reduction in the intimal hyperplasia (IH) formation after DES implantation at the mid-term, late restenosis has been recently noticed. Our objective was to determine, by means of serial angiography (QCA) and intravascular ultrasound (IVUS) at two different time points, whether the occurrence of the "late catch-up" phenomenon occurs after sirolimus-eluting stent (SES) implantation. Thirty-eight non-complex patients treated with a single 18-mm SES who had systematic serial QCA and IVUS analyses at mean 8 and 20 months were enrolled. Primary endpoint is to evaluate the temporal course of IH formation after SES implantation, by comparing QCA in-stent late loss and IVUS percent IH obstruction between the invasive follow-ups. Mean cohort age was 59.3 years and 31.6% were diabetics. Baseline reference vessel diameter was 2.8 ± 0.4 mm and lesion length was 11.5 ± 3.5 mm. Left anterior descending artery was the most frequent target vessel (55.3%). Between 8 and 20 months, a non-significant increase in in-stent late loss from 0.10 ± 0.18 to 0.15 ± 0.30 mm (P = 0.38) was observed. By IVUS, a slight increase in the percent IH obstruction (1.03 ± 2.13 to 1.76 ± 1.87%, P = 0.12) was detected between the two evaluations. Interestingly, all the neoformed tissue accrued from 8 to 20 months accumulated in the distal portion of the stent. In the non-complex scenario, SES implantation was associated with a minimal, non-significant increase in the IH volume between 8 and 20 months.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiovascular Agents/administration & dosage , Coronary Angiography/methods , Coronary Artery Disease/therapy , Coronary Restenosis/diagnosis , Drug-Eluting Stents , Sirolimus/administration & dosage , Tomography, X-Ray Computed , Ultrasonography, Interventional , Aged , Analysis of Variance , Angioplasty, Balloon, Coronary/adverse effects , Brazil , Chi-Square Distribution , Coronary Artery Disease/diagnostic imaging , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Female , Humans , Hyperplasia , Male , Middle Aged , Predictive Value of Tests , Prosthesis Design , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
6.
Catheter Cardiovasc Interv ; 72(2): 156-63, 2008 Aug 01.
Article in English | MEDLINE | ID: mdl-18655121

ABSTRACT

BACKGROUND: Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire Device (RVT-GDW, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario. METHODS: The RAPID-CTO study is a non-randomized, single center, first-in-man evaluation of a new guidewire system for treatment of CTO. The RVT-GDW is a new device designed to provide enhanced penetration and positioning control for crossing CTO via: (1) an 0.014 "guidewire with a mechanically active distal end; (2) a handle attached proximally to the guidewire, with an adjustable torquer, and interfaced to (3) a non-disposable, battery-operated, control unit, that provides activation control and audio feedback during the CTO crossing procedure. Per protocol, the RVT-GDW device was only used after at least 5 min (fluoroscopy time) of attempt with commercially available conventional guidewires to cross the target lesion. RESULTS: A total of 16 patients (16 lesions) were treated with the RVT-GDW. Mean age was 56.25 years, 56.2% were men, and 25% diabetics. The average duration of occlusion was 4.7 +/- 2.1 months. The mean vessel reference diameter was 2.76 +/- 0.31 mm and the mean lesion length was 16.64 +/- 7.70 mm (range 4.37-35.0 mm). Thirteen patients (81.2%) had "tapered stump" morphology at the proximal end of the occlusion, and a side branch was involved in 12 (75.0%). All lesions had contralateral circulation; bridging collaterals were seen in three (18.7%). Procedural success was achieved in 10 lesions (62.5%), with an average procedural time of 111.43 +/- 35.76 min. There were no major adverse cardiac events at both in-hospital and 30-day clinical follow-up. CONCLUSIONS: The first-in-man RAPID-CTO study suggests that the novel RVT-GDW device is technically feasible, safe and effective in crossing chronically occluded coronary arteries. Larger studies are warranted.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Coronary Occlusion/therapy , Angioplasty, Balloon, Coronary/adverse effects , Angioplasty, Balloon, Coronary/methods , Chronic Disease , Coronary Angiography , Coronary Occlusion/diagnostic imaging , Feasibility Studies , Female , Humans , Male , Middle Aged
7.
Rev. bras. cardiol. invasiva ; 16(1): 31-36, jan.-mar. 2008. tab, ilus
Article in Portuguese | LILACS, Sec. Est. Saúde SP | ID: lil-489325

ABSTRACT

Introdução: Pacientes submetidos a intervenção percutânea em hospitais públicos brasileiros não têm acesso aos stents farmacológicos. No início de 2006, participamos de um registro multicêntrico internacional que disponibilizava o uso rotineiro dessas próteses, no cenário do mundo real. Neste artigo, procuramos identificar os perfis clínico, angiográfico e do procedimento de pacientes consecutivamente tratados em períodos subseqüentes de dois meses, de acordo com a disponibilidade desses modelos, visando à identificação de eventuais alterações nesses perfis. Método: Estudo observacional de uma série de 471 pacientes, divididos em dois grupos: A, 229 casos dilatados na vigência da disponibilidade de stents farmacológicos; e B, 242 pacientes subseqüentes tratados da forma usual. Não houve critérios de inclusão/exclusão. Resultados: Stents farmacológicos foram mais implantados no grupo A (44% vs. 2%; p < 0,0001). No que se refere às características de base, observou-se predomínio significante de diabéticos dependentes de insulina em A (8% vs. 3%; p = 0,02), o mesmo ocorrendo com lesões-alvo tipos B2 ou C (73% vs. 57%; p < 0,0001), lesões situadas em bifurcações (15% vs. 9%; p = 0,02) e intervenções multiarteriais (15% vs. 6%; p = 0,003). A angiografia quantitativa identificou os casos de A como portadores de estenoses situadas em vasos de menor calibre (2,4 mm vs. 2,6 mm; p = 0,0004), também exibindo lesões mais longas (14,9 mm vs. 12,7 mm; p = 0,0008). Conclusões: A disponibilidade dos stents farmacológicos gerou alterações no perfil dos casos tratados, que passou a abordar situações mais predispostas à reestenose, como os diabéticos dependentes de insulina, os multiarteriais com lesões de alta complexidade e os portadores de lesões mais longas em vasos de fino calibre.


Introduction: Patients submitted to percutaneous intervention in public hospitals in Brazil have no access to DES. At the beginning of 2006, we participated in an international multicenter registry which made available the routine use of these prosthesis, in a “real world” scenario. In this article, we intend to identify the clinical, angiographical and procedural profiles of the patients, consecutively treated in two-month subsequent periods, according to the availability of these models, with the aim of identifying eventual changes in their profiles. Method: Observational series of 471 patients, divided into two groups: A) 229 cases, treated during a period of availability of DES for routine use; and B) 242 patients subsequently treated as usual (no routine avalilability of DES). There were no inclusion/exclusion criteria. Results: More DES were implanted in group A (44% vs. 2%; p<0.0001). Regarding baseline clinical and angiographic characteristics, a significant predominance of insulin-dependent diabetics was observed in group A (8% vs. 3%; p=0.02), as well as B2 or C lesions (73% vs. 57%; p<0.0001); lesions in bifurcations (15% vs. 9%; p=0.02), and multiarterial interventions (15% vs. 6%; p=0.003). Quantitative angiography identified the A group cases as bearers of stenosis placed in smaller vessels (2.4 mm vs. 2.6 mm; p=0.0004), also exhibiting longer lesions (14.9 mm vs. 12.7 mm; p=0.0008). Conclusions: The availability of DES changed the profile of the patients treated, being more likely situations prone to restenosis, such as insulin dependent diabetics, multiarterial disease, patients presenting complex lesions, longer lesions and smaller target vessels.


Subject(s)
Humans , Male , Middle Aged , Stents , Angioplasty, Balloon, Coronary/methods , Angioplasty, Balloon, Coronary , Coronary Disease/complications , Coronary Disease/diagnosis
8.
Catheter Cardiovasc Interv ; 72: 156-163, 2008.
Article in English | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1061844

ABSTRACT

Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire DeviceTM (RVT-GDWTM, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario. Methods. The RAPID-CTO study is a non-randomized, single center, first-in-man evaluation of a new guidewire system for treatment of CTO. The RVT-GDW is a new device designed to provide enhanced penetration and positioning control for crossing CTO via: (1) an 0.014 ‘‘guidewire with a mechanically active distal end; (2) a handle attached proximally to the guidewire, with an adjustable torquer, and interfaced to (3) a non-disposable, battery-operated, control unit, that provides activation control and audio feedback during the CTO crossing procedure. Per protocol, the RVT-GDW device was only used after at least 5 min (fluoroscopy time) of attempt with commercially available conventional guidewires to cross the target lesion. Results. A total of 16 patients (16 lesions) were treated with the RVT-GDW. Mean age was 56.25 years, 56.2% were men, and 25% diabetics. The average duration of occlusion was 4.7 6 2.1 months. The mean vessel reference diameter was 2.76 6 0.31 mm and the mean lesion length was 16.64 6 7.70 mm (range 4.37–35.0 mm). Thirteen patients (81.2%) had ‘‘tapered stump’’ morphology at the proximal end of the occlusion, and a side branch was involved in 12 (75.0%). All lesions had contralateral circulation; bridging collaterals were seen in three (18.7%). Procedural success was achieved in 10 lesions (62.5%), with an average procedural time of 111.43 6 35.76 min. There were no major adverse cardiac events at both in-hospital and 30-day clinical follow-up. Conclusions. The first-in-man RAPID-CTO study suggests that the novel RVT-GDW device is technically feasible, safe and effective in crossing chronically occluded coronary arteries. Larger studies are warranted.


Subject(s)
Angioplasty , Coronary Disease , Myocardial Revascularization
9.
Rev. bras. cardiol. invasiva ; 15(3): 234-239, jul.-set. 2007. tab, graf
Article in Portuguese | LILACS, Sec. Est. Saúde SP | ID: lil-469928

ABSTRACT

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


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


Subject(s)
Humans , Male , Female , Middle Aged , Stents , Coronary Restenosis/complications , Coronary Restenosis/diagnosis , Sirolimus/analogs & derivatives , Coated Materials, Biocompatible/adverse effects
10.
Rev. bras. cardiol. invasiva ; 15(1): 77-81, jan.-mar. 2007. ilus
Article in Portuguese | LILACS, Sec. Est. Saúde SP | ID: lil-452033

ABSTRACT

É relatado o caso de uma mulher de 40 anos, hipertensa e tabagista, que foi admitida com quadro de infarto agudo do miocárdio sem supradesnivelamento do segmento ST. A cinecoronariografia inicial revelava lesão moderada no terço proximal da artéria circunflexa. Proposto tratamento percutâneo da referida lesão e, no momento do procedimento, a angiografia revelou ausência de lesões na circunflexa e aparecimento de extensa dissecção desde o óstio até o terço médio da artéria descendente anterior, com fluxo distal TIMI III, optando-se por tratamento clínico...


Subject(s)
Humans , Female , Adult , Stents , Aortic Dissection/complications , Aortic Dissection/diagnosis , Angioplasty, Balloon, Coronary/methods , Angioplasty, Balloon, Coronary , Hypertension/complications , Hypertension/diagnosis , Tobacco Use Disorder
11.
Arq Bras Cardiol ; 87(4): e162-7, 2006 Oct.
Article in English, Portuguese | MEDLINE | ID: mdl-17128305

ABSTRACT

The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents2, which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare System's participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the National Health Surveillance Agency (ANVISA). During this stage the interested company submits to the regulatory agency, results from clinical studies that demonstrate the efficacy and safety of the new device or pharmaceutical product. Frequently, in addition to clinical studies, approval records for clinical use from the regulatory agencies of other countries, mainly the United States of America and the European Community are also submitted. The successful completion of this stage means that the medication or device may be prescribed or used by the physicians in Brazil. The second stage in the incorporation of new healthcare technology involves the reimbursement or financing of the treatment that was approved in the previous stage based on its efficacy and safety. This stage can be more complex than the first one since the new technology, whether a substitution for established treatment methods or the introduction of a new treatment concept, are usually more expensive. The incorporation of new technology requires a cost-effectiveness analysis so that fund administrators can make decisions based on the universal scenario of limited resources to finance healthcare with treatments that are more and more burdensome. The difficulties of funding management are aggravated by medical and social ethical implications that arise when a treatment is approved based on its efficacy and safety but is not made available to patients who could benefit greatly from it. In Brazil, assessment methods for the incorporation of new technology based on reimbursement or financing have not been fully developed for either the private healthcare plans or the Brazilian Public Healthcare System (SUS). The implementation of new technology in both healthcare systems is a slow process and frequently the implementation is a result of the requirements of patients or the organizations that represent them and at times is the result of legal proceedings or political pressure imposed by physicians and their respective scientific societies. Our objective is to review the evolution of percutaneous coronary intervention (PCI) in Brazil and its current status in view of the advent of drug-eluting stents, the growing participation of drug-eluting stents in myocardial revascularization to treat patients with coronary heart disease, as well as, to compare the regulatory standards from Brazil and other countries regarding the incorporation and recommendations for the use of this new technology.


Subject(s)
Angioplasty, Balloon, Coronary/methods , Coronary Disease/surgery , Stents , Brazil , Consensus , Coronary Restenosis/prevention & control , Drug Delivery Systems , Humans , Societies, Medical , Stents/economics
12.
Arq. bras. cardiol ; 87(4): e162-e167, out. 2006. graf
Article in Portuguese, English | LILACS | ID: lil-438259

ABSTRACT

Os autores revisam a evolução da intervenção coronariana percutânea, a sua crescente aplicação na revascularização miocárdica de pacientes portadores de doença arterial coronariana, seja no Brasil, seja no âmbito mundial. Desde a introdução do método, em 1977, com a utilização isolada do cateter-balão, a constatação de que o mesmo tinha limitações (oclusão aguda e reestenose), a adoção dos stents coronarianos e, mais recentemente, o advento dos stents farmacológicos, idealizados para reduzir ainda mais as taxas de reestenose, possibilitaram o crescimento exponencial da aplicação da intervenção coronariana percutânea (ICP) no Brasil, superando a cirurgia de revascularização e tornando-se o tratamento majoritário para enfermos sintomáticos, acometidos de aterosclerose obstrutiva coronariana. Esta preferência se salienta, a partir do ano 2000, após o início do reembolso dos stents pelo Sistema de Unico de Saúde Brasileiro. Este fato demonstra a importância do Sistema Público de Saúde, quando este incorpora os avanços médicos, e passa a oferecer bons padrões de tratamento cardiovascular a grande número de brasileiros. Destaca-se a complexidade da profilaxia da reestenose intra-stent, por sua ocorrência imprevisível e ubíqua. O controle deste fenômeno melhora a qualidade de vida, reduzindo o retorno da angina do peito, a realização de novos procedimentos de revascularização e a re-internação hospitalar. Os stents farmacológicos lograram êxito sólido e consistente na conquista deste objetivo de forma abrangente, beneficiando todas as apresentações clínicas e angiográficas, em maior ou menor grau. Sua adoção e critérios para sua utilização em outros países são discutidos, assim como a formalização das indicações preconizadas pela Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista, para o seu reembolso pelo SUS. A incorporação de novas tecnologias em saúde é um processo que compreende duas etapas distintas: na primeira, o registro do produto é efetivado na Agência Nacional de Vigilância Sanitária (ANVISA)...


The authors review percutaneous coronary intervention (PCI) evolution and its growing application in myocardial revascularization for patients with coronary heart disease in Brazil and worldwide. PCI was introduced in 1977 using only the catheter balloon. Limitations of this method (acute occlusion and coronary restenosis) led to the adoption of coronary stents and more recently the advent of drug-eluting stents², which were developed to drastically reduce restenosis rates. These developments allowed the exponential growth of percutaneous coronary intervention (PCI) procedures in Brazil which have replaced many bypass surgery procedures and have become the gold standard for the majority of symptomatic patients suffering from coronary artery disease. The preference for this procedure gained new dimensions in 2000 when the Brazilian Public Healthcare System (SUS) began reimbursing for stent procedures. This measure exemplified the importance of the Public Healthcare System's participation in incorporating medical advances and offering a high standard of cardiovascular treatment to a large portion of the Brazilian population. It is emphasized that prevention of in-stent restenosis is complex due to its unpredictable and ubiquitous occurrence. Control of this condition improves quality of life and reduces the recurrence of angina pectoris, the need to perform new revascularization procedures and hospital readmissions. The overall success of the drug-eluting stents has proven to be reliable and consistent in overcoming restenosis and has some beneficial impact for all clinical and angiographic conditions. This paper discusses the adoption and criteria for the use of drug-eluting stents in other countries as well as the recommendations established by the Brazilian Society of Interventional Cardiology for their reimbursement by SUS. The incorporation of new healthcare technology involves two distinct stages. During the first stage, the product is registered with the National Health Surveillance Agency (ANVISA)...


Subject(s)
Humans , Angioplasty, Balloon, Coronary/methods , Coronary Disease/surgery , Myocardial Revascularization/methods , Stents , Brazil , Coronary Restenosis/prevention & control , Drug Delivery Systems , Societies, Medical , Stents/economics
14.
Arq. bras. cardiol ; 83(n.spe): 59-63, dez. 2004. tab
Article in Portuguese | LILACS, Sec. Est. Saúde SP | ID: lil-390724

ABSTRACT

OBJETIVO: A reestenose intra-stent é a maior limitação das intervenções coronárias percutâneas. O carbeto de silício amorfo (SiC-a), substância antitrombótica e antiinflamatória capaz de reduzir a deposição de fibrina, plaquetas e leucócitos sobre o stent, apresenta potencial de prevenir a hiperplasia neo-intimal e a reestenose. MÉTODOS: Estudo prospectivo, randomizado e tipo rótulo aberto comparando pacientes com doença coronariana tratados com e sem stents revestidos com o SiC-a, utilizando a angiografia quantitativa e o ultra-som intracoronário. Foram incluídos 100 pacientes (50 em cada grupo) a fim de mensurar o volume de hiperplasia neo-intimal intra-stent/extremidades. Como os stents comparados apresentavam extensões diferentes, o volume de hiperplasia foi analisado em valores absolutos (por paciente) e relativos (por milímetro de extensão do stent). Avaliaram-se ainda os eventos cardíacos maiores e os resultados da angiografia quantitativa. RESULTADOS: Os grupos apresentaram características de base semelhantes. Todos os pacientes foram tratados com sucesso. No 6° mês de evolução foram reestudados 94 por cento dos casos dos dois grupos, obtendo-se ultra-som em 92 por cento. O volume de hiperplasia neo-intimal absoluto foi significativamente maior nos tratados com os stents revestidos (51.2 DP 18.8 mm³ vs 41.9 DP 16.4 mm³; p=0.014), porém o relativo foi semelhante (2.9 DP 1.0 mm³/mm stent vs 2.5 DP 0.9 mm³/mm stent; p=0.108). A obstrução volumétrica da luz também foi similar (36.4 DP 11.1 por cento vs 37.9 DP 10.9 por cento; p=0.505). O diâmetro mínimo da luz (1.9 DP 0.7 mm vs 1.8 DO 0.6 mm; p=0.552), a reestenose (19.1 por cento vs 17 por cento; p>0.999) e a revascularização do vaso-alvo (16 por cento vs 14 por cento; p>0.999) não diferiram. CONCLUSÃO: Os stents revestidos apresentaram resultados clínicos, angiográficos e ultra-sonográficos similares aos controles.


Subject(s)
Female , Humans , Male , Middle Aged , Biocompatible Materials/therapeutic use , Carbon Compounds, Inorganic/therapeutic use , Coronary Disease/surgery , Coronary Restenosis/prevention & control , Silicon Compounds/therapeutic use , Stents , Coronary Angiography , Coronary Disease , Hyperplasia/prevention & control , Prospective Studies , Treatment Outcome , Tunica Intima/pathology , Tunica Intima
15.
Rev Bras Cardiol Invas ; 12(2): 96-101, abr.mai.jun 2004. tab
Article in Portuguese | Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1066254

ABSTRACT

Os tents farmacológicos são maior avanço tecnológico já produzido na área de cardiologia intervencionista com a finalidade de tratar a doença arterial coronária. Eles vieram coroar anos de pesquisas que aprimoram o instrumental terapêutico endovascular iniciado com o balão desenvolvido por Andreas Grüntzig, cuja indicação era bastante restrita e suas complicações nada desprezíveis, até o desenvolvimento destas próteses de extrema navegabilidade, muito baixo perfil e capazes de carrear consigo substâncias bioativas. este desnvolvimento propiciou um aumento muito expressivo na indicação da técnica com índices de complicação extremamente baixos. Neste artigo fizemos uma revisão sitemática do tema, abordando as características inerentes a este dispositivo: stent-polímero fármaco...


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Disease , Stents/trends
16.
In. Sousa, Amanda GMR; Piegas, Leopoldo S; Sousa, J Eduardo MR. Série monografias Dante Pazzanese. Rio de Janeiro, Revinter, 2004. p.1-51, ilus, ilus.
Non-conventional in Portuguese | LILACS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1069430

ABSTRACT

A reperfusão coronária promoveu marcante transformação no tratamento dos pacientes com infarto do miocárdio, beneficiando grande número de enfermos no último quarto do século passado. O método mais adequado deve promover a lise do trombo coronário oclusivo e reduzir simultaneamente, a estenose coronária subjacente, que, associadas, constituem o binômio patogênico para o estabelecimento do infarto agudo do miocárdio. A primeira série de 12 pacientes consecutivos submetidos à angioplastia transluminal coronária na vigência de infarto agudo do miocárdio, sem o uso prévio de fibrinolíticos, foi relatada em 1983. A patir de 1993, foram realizados estudos randomizados, comparando os dois métodos de reperfusão coronária, farmacológico e mecânico...


Subject(s)
Angioplasty, Balloon , Coronary Stenosis , Myocardial Infarction/therapy , Myocardial Reperfusion/history , Stents
17.
Rev. Soc. Cardiol. Estado de Säo Paulo ; 11(4): 853-865, jul.-ago. 2001. tab, graf
Article in Portuguese | LILACS, Sec. Est. Saúde SP | ID: lil-394933

ABSTRACT

A recanalização da artéria epicárdica culpada foi o grande avanço no tratamento do infarto agudo do miocárdio. A estratégia farmacológica com fibrinolíticos permitiu a obtenção de amplo benefício clínico, documentado pela redução da mortalidade em diversos estudos. A utilização endovenosa dessas drogas, entretanto, também exibe limitações, entre outras o baixo porcentual de patência do vaso culpado, com fluxo veloz e persistente. A obtenção desse fluxo TIMI 3 correlaciona-se diretamente com maior sobrevida, adquirindo grande importância em qualquer estratégia de reperfusão no infarto agudo do miocárdio. Paralelamente, a estratégia mecânica de reperfusão no infarto agudo do miocárdio demonstrou sua vantagem em relação aos fibrinolíticos, já na angioplastia com balão, nos estudos clínicos da década de 90. Assim sendo, a intervenção percutânea, nessa condição, promove maior sobrevida, menor reinfarto e menor necessidade de nova revascularização, com maior segurança. A incorporação dos stents coronarianos ampliou tais benefícios, tanto pelo alto perfil de segurança de implante como pela redução da reestenose. Mais recentemente, atenção especial foi dada à microcirculação e à reperfusão tecidual completa no infarto agudo do miocárdio, permitindo a introdução de novos fármacos (inibidores da glicoproteína IIb/IIIa), que, com sinergismo, potencializaram a vantagem da angioplastia primária, na otimização dos resultados apresentados. Recentemente, com o estudo CADILLAC, a Cardiologia Intervencionista sintetiza a estratégia mecânica de reperfusão no infarto agudo do miocárdio, que, no momento, direciona nossas condutas.


Subject(s)
Humans , Aged , Streptokinase , Tissue Plasminogen Activator/therapeutic use , Fibrinolytic Agents/therapeutic use , Myocardial Infarction/surgery , Myocardial Infarction/therapy , Time Factors , Stents , Angioplasty , Diabetes Mellitus , Shock, Cardiogenic , Platelet Aggregation Inhibitors , Meta-Analysis , Perfusion , Myocardial Reperfusion
18.
Rev. Soc. Cardiol. Estado de Säo Paulo ; 10(1): vii-xxvii, jan.-fev. 2000. ilus, tab
Article in Portuguese | LILACS, Sec. Est. Saúde SP | ID: lil-266110

ABSTRACT

A revascularizaçäo miocárdica percutânea, iniciada pela contribuiçäo original de Andreas Guentizig, em 1977, experimentou, em duas décadas, extraordinário desenvolvimento e representa, hoje, a coluna mestra da Cardiologia Intervencionista. Dos balöes aos stents houve enorme ganho-de-efetividade, a curto e a longo prazos, com ampliaçäo substancial da segurança, já que as taxas de complicaçöes maiores foram reduzidas em mais de dez vezes. As endopróteses coronárias têm comprovado efeito preventivo em relaçäo à reestenose, reduzindo-a em 50 'por cento'quando comparadas ao baläo. Contudo, resta ainda o problema da reestenose intra-stent para ser mais bem resolvido. Novos subgrupos de pacientes têm sido incluídos nas indicaçöes atuaais, destacando-se os multiarteriais, aqueles com infarto agudo do miocárdio e os com lesöes em pontes de veia safena. Restam ainda mais alguns, em que o delineamento do benefício requer comprovaçäo, como os portadores de vasos-alvo de pequeno diâmetro e os com lesöes longas ou em bifurcaçäo. A questäo de custo-efetividade, por fim, näo é de menor importância e constitui linha de investigaçäo de grande interesse atual.


Subject(s)
Humans , Stents/trends , Stents , Myocardial Revascularization/history , Myocardial Revascularization/methods , Myocardial Revascularization/trends , Time Factors
19.
Arq. bras. cardiol ; 70(6): 423-430, Jun. 1998.
Article in Portuguese | LILACS | ID: lil-320310

ABSTRACT

PURPOSE: To report the results of percutaneous coronary interventions, in Brazil, in the years 1996-97, comparing them to those of 1992-93. METHODS: Data were collected in a standard form and the 1996-97 results were compared to those of 1992-93. RESULTS: The current Registry received data from 79effective members of the SBHCI in 127 hospitals, including 22,025 patients, 60.67of whom underwent PTCA, 36.57stent implantation, 2.3PTRA, 0.06DCA and 0.4laser angioplasty. Balloon angioplasty was the most frequent procedure in 1996-97, but its overall rate fell from 6.75to 55.8(p = 0.0001) concomitantly, there was a 35relative increase in the use of stents from 1992-93 to 1996-97. The success rate of the later period was higher (89.7vs 92.8, p = 0.000001), with lower residual stenosis (22vs 19, p = 0.001). Besides, there were lower major complications rates: acute myocardial infarction (2.5vs 1.2, p = 0.002) and death (1.8vs 1.4, p = 0.0003). CONCLUSION: The procedures most often carried out in both periods were balloon angioplasty (60.67) and implantation of stents (36.57); the success rate high, abrupt closure rate was low (1.5). These favorable results corroborate the high standards of the Brazilian Interventional Cardiology.


Subject(s)
Humans , Aged , Angioplasty , Coronary Disease , Myocardial Revascularization , Registries , Aged, 80 and over , Angioplasty , Brazil , Stents , Treatment Outcome
20.
Arq. bras. cardiol ; 68(2): 73-77, Fev. 1997. tab
Article in Portuguese | LILACS | ID: lil-320362

ABSTRACT

PURPOSE: To analyse the influence of unstable coronary syndromes (UCS) in the early and late prognosis after rotational atherectomy (RA). METHODS: We treated 236 patients with RA between Aug/1992 and May/1996. Patients were divided into two groups: A) stable coronary syndromes 120 (51) patients; B) UCS: 116 (49) patients. Definitions: 1) procedure success (PS)--lesion success in all locations were RA use was attempted, without a major complication; 2) late coronary events (LCE)--angina, MI, additional revascularization or death. RESULTS: There was a significant predominance of age > 70 (A = 14x B = 24, p = 0.03) in B and previous MI (A = 32x B = 11, p = 0.0001) in A. Other characteristics were similar in both groups, including complex lesions (type B2/C), which were observed in 77A stenosis and 80B lesions. PS was 95in A and 92in B (p = NS). In-hospital major complications were observed in 2.5A and 4.3B patients, (p = NS). One patient died in each group. A and B patients had similar time of follow-up. LCE occurred in 25A and 39B patients (p = 0.002). Recurrence of angina (36x 23; p = 0.01) and target lesion revascularization (29x 18; p = 0.03) were also more frequently required in B cases. CONCLUSION: This study suggests that UCS (group A) does not implicate in worse acute results after RA. However, UCS patients present greater incidence of late coronary events, particularly recurrence of angina and target-lesion revascularization.


Subject(s)
Humans , Male , Female , Aged , Coronary Disease , Atherectomy, Coronary/methods , Retrospective Studies , Follow-Up Studies , Treatment Outcome , Coronary Angiography , Postoperative Complications , Chi-Square Distribution
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