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INTRODUÇÃO: A nefropatia induzida pelo contraste (NIC) é uma complicação potencial após a intervenção coronária percutânea (ICP). A patogênese está associada a mecanismos inflamatórios, disfunção endotelial e estresse oxidativo, e as estatinas, por seus efeitos pleiotrópicos, vêm sendo analisadas nesse cenário. Avaliamos se uma dose de reforço de rosuvastatina pré-ICP eletiva, em pacientes em uso crônico de estatina, reduz a ocorrência de NIC. MÉTODOS: Estudo prospectivo, randomizado, aberto, realizado em único centro. Os pacientes foram divididos de acordo com a utilização (grupo 1) ou não (grupo 2) de 40 mg de rosuvastatina, 2 a 6 horas pré-ICP. A frequência de NIC foi comparada entre os dois grupos e nos subgrupos de diabéticos e com disfunção renal prévia. RESULTADOS: Foram incluídos 135 pacientes, com idade de 60,7 + 9,3 anos, randomizados para o grupo 1 (n = 67) ou para o grupo 2 (n = 68). A prevalência de diabetes foi de 31,1% e de clearance de creatinina < 60 ml/min, de 13,3%. A incidência de NIC foi de 8,1% e não mostrou diferença entre os grupos (9% vs. 7,4%; P = 0,89). A incidência de NIC nos diabéticos foi de 15% vs. 13,6% (P = 0,75) e nos portadores de disfunção renal prévia foi de 12,5% vs. 0 (P = 0,93). CONCLUSÕES: O uso de uma dose de reforço de rosuvastatina em sua posologia máxima não exerceu efeito protetor renal nos pacientes em uso crônico de estatina submetidos a ICP eletiva. BACKGROUND: Contrast-induced nephropathy (CIN) is a potential complication after percutaneous coronary intervention (PCI). The pathogenesis is associated to inflammatory mechanisms, endothelial dysfunction and oxidative stress and the use of statins, due to their pleiotropic effects, has been investigated in this setting. We assessed whether a preload dose of rosuvastatin prior to elective PCI in patients on chronic statin reduces the incidence of CIN. METHODS: Prospective, randomized, open label, single-center study. Patients were divided according to the use (group 1) or not (group 2) of rosuvastatin 40 mg, 2-6 hours prior to PCI. The frequency of CIN was compared between the two groups as well as in the diabetic and renal dysfunction subgroups. RESULTS: We included 135 patients, with 60.7 + 9.3 years of age, randomized to group 1 (n = 67) or group 2 (n = 68). The prevalence of diabetes was 31.1% and the prevalence of creatinine clearance < 60 ml/min was 13.3%. The incidence of CIN was 8.1% and there was no difference between groups (9% vs. 7.4%; P = 0.89). The incidence of CIN in diabetic patients was 15% vs. 13.6% (P = 0.75) and in those with renal dysfunction it was 12.5% vs. 0 (P = 0.93). CONCLUSIONS: The use of a preload dose of rosuvastatin at its maximum dosage did not exert a protective effect in renal function of chronic statin users undergoing elective PCI.

INTRODUÇÃO: A maior taxa de trombose tardia observada após implante de stents farmacológicos de primeira geração trouxe preocupação acerca de sua segurança a longo prazo. Inflamação vascular local e cicatrização tardia foram identificadas como importantes substratos para esse fenômeno. Polímero persistente, fármaco antiproliferativo ou ambos foram identificados como importantes fatores etiológicos. No estudo atual procuramos investigar o desempenho e a eficácia do novo stent eluidor de paclitaxel Amazonia-PAX, sem cobertura polimérica, em comparação com o stent de primeira geração eluidor de paclitaxel Taxus Liberté, com cobertura polimérica. MÉTODOS: O PAX-A é um estudo prospectivo, randomizado, cego e unicêntrico, no qual pacientes com lesões únicas, de novo, < 20 mm, em coronárias de 2,5 mm a 3,5 mm de diâmetro, foram randomizados para receber o stent Amazonia-PAX (n = 16) ou o stent Taxus Liberté (n = 15). Os desfechos primários foram a perda luminal tardia intrastent e a porcentagem do volume de obstrução intrastent por ultrassom intracoronário (USIC) 4 meses após o procedimento. Os desfechos secundários foram constituídos por reestenose binária e variação dos volumes do vaso, lúmen e stent pelo USIC aos 4 meses, bem como a ocorrência de eventos cardíacos adversos maiores [ECAM: morte, infarto do miocárdio (IM) não-fatal e revascularização da lesão-alvo (RLA)] em um ano. RESULTADOS: Não foram observadas diferenças nas características clínicas e angiográficas basais. No seguimento de 4 meses, a perda luminal tardia intrastent (0,77 [0,47-1,05] mm vs. 0,42 [0,17-0,86] mm; P = 0,29) e a porcentagem do volume de obstrução intrastent (19,2 + 9,5% vs. 9,3 + 10,1%; P = 0,08) foram maiores no stent Amazonia-PAX. Em um ano, a taxa de ECAM foi de 18,7% no grupo Amazonia-PAX e de 26,7% no grupo Taxus Liberté (P = 0,8). Houve uma morte e dois IMs não-fatais nos grupos Taxus Liberté e Amazonia-PAX, respectivamente. Dois pacientes no grupo Amazonia-PAX e 4 pacientes no grupo Taxus Liberté necessitaram RLA. CONCLUSÕES: O stent eluidor de paclitaxel não-polimérico Amazonia-PAX promoveu moderada inibição da hiperplasia intimal em comparação com o stent eluidor de paclitaxel com polímero durável de primeira geração Taxus Liberté. BACKGROUND: Increased rates of late stent thrombosis after first-generation drug eluting stents have prompted concerns about its long-term safety. Local vascular inflammation and delayed healing have been identified as important substrates. Persistent polymer, anti-proliferative drug, or both, have been identified as important etiological factors. In the present study we sought to investigate the performance and efficacy of the novel polymer-free Amazonia-PAX paclitaxel-eluting stent against the first-generation, polymer-based Taxus Liberté paclitaxel-eluting stent. METHODS: PAX-A is a prospective, randomized, single-blinded, single-center study, in which patients with single de novo, < 20 mm lesions, in native coronaries of 2.5 mm to 3.5 mm diameter were randomized to receive the Amazonia-PAX stent (n = 16) or the Taxus Liberté stent (n = 15). Primary end-points were in-stent late luminal loss by QCA and in-stent % obstruction volume by intravascular ultrasound (IVUS) at 4-month follow-up. Secondary end-points included binary restenosis and changes in vessel, lumen and stent volume detected by IVUS at the 4-month follow-up, as well as major adverse cardiac events [MACE: death, non-fatal myocardial infarction (MI) and target lesion revascularization (TLR)] at one year. RESULTS: No differences were observed in the baseline clinical and angiographic characteristics. At the 4-month follow-up in-stent late luminal loss (0.77 [0.47-1.05] mm vs. 0.42 [0.17-0.86] mm; P = 0.29) and in-stent % obstruction volume (19.2 + 9.5% vs. 9.3 + 10.1%; P = 0.08) were higher in the Amazonia-PAX stent. At 1 year, MACE rate was 18.7% in the Amazonia-PAX group and 26.7% in the Taxus Liberté group (P = 0.8). One death and two non-fatal MIs were detected in the Taxus Liberté and Amazonia-PAX groups, respectively. Two patients in the Amazonia-PAX and 4 patients in the Taxus Liberté required TLR. CONCLUSIONS: The polymer-free Amazonia-PAX paclitaxel-eluting stent promoted a moderate intimal hyperplasia inhibition as compared to the first-generation polymer-based paclitaxel-eluting stent Taxus Liberté.

INTRODUÇÃO: Embora os stents farmacológicos tenham reduzido de forma inconteste o crescimento neointimal e sua consequência clínica direta, a reestenose, questionamentos acerca de sua segurança a longo prazo têm motivado o desenvolvimento de novas tecnologias. A aplicação sistêmica de fármacos antiproliferativos teria o potencial de solucionar o problema da reestenose e ao mesmo tempo amenizar a questão da segurança tardia inerente aos polímeros sintéticos. Recentemente, estudo investigando a administração intravenosa de uma solução de paclitaxel ligado à albumina (ABI-007) produziu efeito discreto na redução da formação de tecido neointimal. Este trabalho teve como objetivo avaliar, por meio da angiografia e do ultrassom intracoronário (USIC) seriados, a efetividade da aplicação intracoronária do ABI-007 na supressão da hiperplasia neointimal após implante de stents não-farmacológicos MÉTODO: Entre novembro de 2006 e maio de 2007, pacientes portadores de lesões coronárias de novo, com extensão < 18 mm, em vasos nativos de 2,5 mm a 3,5 mm de diâmetro, foram submetidos a intervenção coronária percutânea com implante de stents não-farmacológicos, seguida de injeção intracoronária de 70 mg/m² de ABI-007. Avaliação com angiografia e USIC foi programada para todos os pacientes imediatamente após o procedimento e aos seis meses de seguimento. Desfecho primário era a perda luminal tardia (QCA) e o porcentual de obstrução volumétrica gerado pela hiperplasia neointimal (USIC) aos seis meses RESULTADOS: Foram incluídos 11 pacientes, com média de idade de 58,4 ± 7,3 anos, 54% do sexo feminino e 18,2% de diabéticos. A artéria descendente anterior foi o vaso mais frequentemente tratado (45,5%) e a maioria das lesões era do tipo A/B1 (63,7%). A administração de ABI-007 foi bem tolerada por todos os pacientes. Aos seis meses, a perda luminal tardia foi de 0,84 ± 0,46 mm, tendo sido identificados três casos (27,3%) de reestenose binária. Ao USIC, o porcentual de obstrução volumétrica foi de 38,4 ± 16,2%. Não houve casos de remodelamento vascular significativo, nem de má-aposição tardia dos stents. Ao final de dois anos, não houve ocorrência de eventos cardíacos maiores CONCLUSÃO: Embora a administração intracoronária de ABI-007 tenha sido bem tolerada, sem efeitos tóxicos adversos reportados, essa modalidade terapêutica apresentou baixa capacidade de suprimir a formação de tecido neointimal após implante de stents nãofarmacológicos, com perda tardia e porcentual de obstrução volumétrica semelhantes aos observados após implante de stents não-farmacológicos isolados. BACKGROUND: Although drug-eluting stents have proven to be highly effective in decreasing neointimal hyperplasia and its direct clinical consequence, restenosis, concerns regarding their long-term safety have led to the development of new technologies. The systemic use of antiproliferative drugs may resolve restenosis while minimizing the longterm safety issues inherent to synthetic polymers. Recently, a study investigating the intravenous administration of albumin-bound paclitaxel (ABI-007) showed that it produced a mild effect on the reduction of neointimal tissue formation. The present study was aimed at investigating, by means of serial angiography and intravascular ultrasound (IVUS), the efficacy of intracoronary ABI-007 administration in the suppression of neointimal hyperplasia after bare-metal stent implantation METHOD: From November 2006 and May 2007, patients with de novo coronary lesions < 18 mm were submitted to percutaneous coronary intervention using bare-metal stents, followed by a 70 mg/m² intracoronary injection of ABI-007. Angiography and IVUS assessment was planned for all of the patients immediately after the procedure and at the six-month follow-up. The primary end-point was late lumen loss (LL) and percent neointimal volume obstruction caused by neointimal hyperplasia (IVUS) at 6 months RESULTS: 11 patients were included, with mean age of 58.4 ± 7.3 years, 54% were female and 18.2% diabetics. Left anterior descending artery was the most frequent vessel treated (45.5%) and most of the lesions were type A/B1 (63.7%). ABI-007 administration was well tolerated by all patients. At the 6-month follow-up, LL was 0.84 ± 0.46 mm and three cases (27.3%) of binary restenosis were identified. IVUS percent volumetric obstruction was 38.4 ± 16.2%. No cases of significant vascular remodeling or late acquired stent malapposition were observed. After two years, there were no cases of major adverse cardiac events CONCLUSION: Although the intracoronary ABI-007 administration was well tolerated, with no adverse toxic events reported, this treatment modality demonstrated a low capacity of suppressing neointimal tissue formation after bare-metal stent implantation, with late loss and percent of volumetric obstruction percentages similar to those observed after bare-metal stent implantation alone.

INTRODUÇÃO: Reportamos a incidência e preditores de nova revascularização da lesão-alvo (RLA) numa coorte de pacientes do mundo real tratados com stents farmacológicos (SF) MÉTODO: Entre maio de 2002 e fevereiro de 2010, 3.320 pacientes de único centro foram submetidos a intervenção percutânea (ICP), eletiva ou de urgência, com implante de 5.320 SF (Cypher, 83%; Taxus, 9%; Xience V/Promus, 3%; Endeavor, 4%; BioMatrix, 1%). O seguimento clínico de até oito anos (mediana, 3,4 anos) foi completo em 98% do grupo e 129 pacientes (3,88%) foram submetidos a RLA RESULTADOS: Entre os pacientes com RLA, 33% tinham diabetes, 10% eram portadores de insuficiência renal e 61%, de doença em múltiplos vasos. A artéria descendente anterior foi o vaso mais frequentemente tratado (33%), e 72,3% das lesões eram de alta complexidade (tipo B2/C). Nesse grupo, foram implantados 214 SF em 191 lesões e 45% dos pacientes receberam múltiplos stents. Na análise univariada, os preditores de RLA foram: diabetes melito [razão de risco (RR) 1,88, intervalo de confiança (IC) de 95% 1,08-3,27; P = 0,025), uso do stent Taxus (RR 1,73, IC 95% 1,20-2,50; P = 0,003), lesão ostial (RR 1,82, IC 95% 1,1-2,98; P = 0,018), ponte de safena (RR 2,36; IC 95% 1,55-3,50; p = 0,0001), e lesões reestenóticas (RR 1,95, IC 95% 1,17-3,24; P = 0,009). Após análise multivariada, permaneceram como preditores independentes: diabetes melito, uso do stent Taxus e tratamento de lesões em pontes de safena (RR 1,64, IC 95% 1,14-2,35; P = 0,008) CONCLUSÃO: No registro DESIRE, a RLA em pacientes complexos tratados com SF foi baixa, e o diabetes melito, o tratamento de lesões em ponte de safena e o uso de SF Taxus foram os únicos preditores de RLA no acompanhamento clínico de até oito anos. BACKGROUND: We report the incidence and predictors of target lesion revascularization (TLR) in a cohort of realworld patients treated with drug eluting stents (DES) METHOD: From May 2002 to February 2010, 3,320 patients were treated with elective or emergency percutaneous coronary intervention (PCI) and 5,320 DES (Cypher, 83%; Taxus, 9%; Xience V/Promus, 3%; Endeavor, 4%; BioMatrix, 1%) were implanted in a single center. The clinical follow-up of up to eight years (median time 3.4 years) was concluded in 98% patients of the group and 129 patients (3.88%) were submitted to TLR RESULTS: Of the patients with TLR, 33% had diabetes, 10% had chronic kidney disease and 61% had multivessel disease. The left anterior descending artery was the most frequent target vessel (33%) and 72.3% of the lesions were complex lesions (type B2/C). In this group, 214 DES were implanted in 191 lesions and 45% of the patients received multiple stents. In the univariate analysis, TLR predictors were: diabetes mellitus [relative risk (RR) 1.88, 95% confidence interval (CI) 1.08-3.27; P = 0.025], use of Taxus stents (RR 1.73, 95% CI 1.20-2.50; P = 0.003), ostial lesion (RR 1.82, 95% CI 1.1-2.98; P = 0.018), saphenous bypass graft (RR 2.36, 95% CI 1.55-3.50; P = 0.0001), and restenotic lesions (RR 1.95, 95% CI 1.17-3.24; P = 0.009). After the multivariate analysis, the independent predictors were: diabetes mellitus, use of Taxus stents and treatment of lesions in saphenous bypass grafts (RR 1.64, 95% CI, 1.14-2.35; P = 0.008) CONCLUSION: In the DESIRE registry, TLR in complex patients treated with DES was low and diabetes mellitus, treatment of lesions in saphenous bypass grafts and the use of Taxus stents were the only TLR predictors in the clinical follow-up of up to 8 years.

INTRODUÇÃO: Os diabéticos representam um desafio para as intervenções coronárias percutâneas (ICP) em decorrência das elevadas taxas de reestenose, limitando a utilização desse procedimento em situações com grande perspectiva de recidiva, restringindo o emprego da técnica e predispondo à revascularização incompleta. Os stents farmacológicos contribuíram para a atenuação expressiva dessas limitações, podendo ter causado mudanças nas características dos casos tratados contemporaneamente. Assim, nosso objetivo foi comparar o perfil dos diabéticos tratados por ICP em dois momentos distintos desta década MÉTODO: Estudo de coorte envolvendo 2.530 pacientes diabéticos revascularizados de forma consecutiva, divididos em dois grupos: grupo A, 1.309 pacientes revascularizados no período de 2006 a 2008; e grupo B, 1.221 pacientes tratados entre 2003 e 2005. Excluíram-se apenas os pacientes em que foram utilizados stents farmacológicos não disponíveis para uso comercial RESULTADOS: Os stents farmacológicos foram mais utilizados no grupo A (23% vs. 9%; P < 0,0001), em que também ocorreu predomínio significante de pacientes em uso de insulina (14% vs. 10%; P = 0,0001), com disfunção renal crônica (20% vs. 10,1%; P < 0,0001), lesões B2/C (68% vs. 63%; P = 0,003), oclusões crônicas (17% vs. 10%; P < 0,0001), stents com diâmetro < 2,5 mm (26% vs. 22%; P = 0,01) e stents com extensão > 24 mm (31% vs. 22%; P < 0,0001). Intervenções multiarteriais (12% vs. 6%; P < 0,001) e revascularização completa (65% vs. 59%; P = 0,002) também predominaram no grupo A. Os resultados clínicos hospitalares não diferiram CONCLUSÃO: A maior disponibilidade de stents farmacológicos causou alterações substanciais no perfil dos diabéticos tratados contemporaneamente, ampliando as indicações para casos mais complexos e proporcionando a obtenção de uma revascularização miocárdica mais completa. BACKGROUND: Diabetic patients represent a challenge for percutaneous coronary interventions (PCI) due to the high restenosis rates, which limit the use of the procedure in cases prone to recurrences, predisposing patients to incomplete revascularization. Drug-eluting stents (DES) have contributed for a significant improvement of these limitations and may have caused changes in the characteristics of patients treated contemporaneously. Thus, our objective was to compare the profile of diabetic patients treated in two different periods of this decade METHOD: This was a consecutive cohort study including 2,530 diabetic patients who were divided into two groups: group A, 1,309 patients revascularized from 2006 to 2008; and group B, 1,221 patients treated from 2003 to 2005. Only patients using DES not commercially available were excluded RESULTS: DES were more frequently used in group A (23% vs. 9%; P < 0.0001), which has a higher prevalence of insulinrequiring patients (14% vs. 10%; P = 0.0001), chronic renal failure (20% vs. 10.1%; P < 0.0001), B2/C lesions (68% vs. 63%; P = 0.003), total occlusions (17% vs. 10%; P < 0.0001), stent diameter < 2.5 mm (26% vs. 22%; P = 0.01) and stent length > 24 mm (31% vs. 22%; P < 0.0001). Multivessel interventions (12% vs. 6%; P < 0.001) and complete revascularization (65% vs. 59%; P = 0.002) also prevailed in group A. Clinical hospital results were not different between groups CONCLUSION: The greater availability of DES has led to significant changes in the profile of diabetic patients treated currently, expanding the indications for more complex patients and providing a more complete myocardial revascularization.

INTRODUÇÃO: A intervenção coronária percutânea em pontes de safena continua sendo um grande desafio por apresentar maiores taxas de complicações associadas ao procedimento. O novo stent balão-expansível MGuardTM foi desenvolvido com uma malha polimérica ultrafina revestindo a porção externa de um stent convencional, com o objetivo de reduzir a embolização distal durante a intervenção. Nosso objetivo foi avaliar a eficácia do novo dispositivo em prevenir as complicações embólicas periprocedimento. MÉTODOS: Avaliamos uma coorte consecutiva de pacientes com lesões complexas em pontes de safena tratados com stent MGuardTM, que foi comparada a pacientes tratados de maneira convencional com stent e filtros de proteção distal. O objetivo primário incluiu a ocorrência de eventos cardiovasculares adversos maiores (morte, infarto agudo do miocárdio e revascularização da lesão-alvo) em até 30 dias do procedimento. RESULTADOS: Foram analisados 38 pacientes, 16 no grupo MGuardTM e 22 pacientes no grupo filtro de proteção distal. A maioria era do sexo masculino (81,6%), e a média de idade dos enxertos foi de 10,4 ± 5,6 anos. Os pacientes do grupo filtro de proteção distal apresentaram lesões mais longas (17,4 ± 6,3 mm vs. 26 ± 16,2 mm; P = 0,052) e com maior carga trombótica quando comparados aos do grupo MGuardTM (6,3% vs. 50%; P = 0,005). Em nenhum dos dois grupos ocorreram eventos cardíacos adversos maiores nos primeiros 30 dias de evolução. CONCLUSÕES: O stent MGuardTM demonstrou, em nossos pacientes, ser um dispositivo eficaz no tratamento de lesões complexas em pontes de safena. Comparações randomizadas e com maior número de pacientes deverão ser realizadas no futuro para confirmar esses resultados preliminares. BACKGROUND: Percutaneous coronary intervention in saphenous vein grafts remain a major challenge due to the high complication rates associated to the procedure. The new balloon-expandable MGuardTM stent was developed with an ultra-thin mesh sleeve attached to its outer surface, designed to reduce distal embolization during the procedure. Our objective was to evaluate the efficacy of the new device to prevent periprocedural embolic complications. METHODS: A consecutive cohort of patients with complex saphenous vein graft lesions treated with the MGuardTM stent were compared to patients treated with bare metal stents and distal filter protection. The primary objective included the occurrence of major adverse cardiovascular events (composite of death, non-fatal myocardial infarction and target lesion revascularization) up to 30 days of the procedure. RESULTS: Thirty-eight patients were evaluated, 16 in the MGuardTM group and 22 patients in the distal filter protection group. Most patients were male (81.6%) and the mean age of the treated grafts was 10.4 ± 5.6 years. Distal filter protection group patients had longer lesions (17.4 ± 6.3 mm vs. 26 ± 16.2 mm; P = 0.052) and higher thrombus burden (6.3% vs. 50%; P = 0.005). There were no major adverse cardiac events in any of the groups up to 30 days of the procedure. CONCLUSIONS: The MGuardTM stent proved to be effective in the treatment of complex saphenous vein graft lesions in our series of patients. Randomized comparisons with a larger number of patients must be carried out in the future to confirm these preliminary results.

INTRODUÇÃO: Neste estudo, buscamos avaliar os resultados clínicos de pacientes com lesões coronárias em vasos de fino calibre, numa coorte de pacientes do mundo real submetidos a intervenção coronária percutânea (ICP) com stents farmacológicos. MÉTODOS: Entre maio de 2002 e dezembro de 2009, 1.380 pacientes consecutivos do Registro DESIRE (Drug Eluting Stents In the Real World), com 1.683 lesões em vasos de fino calibre (< 2,5 mm de diâmetro), foram submetidos a ICP, eletiva ou de urgência, com implante de 1.818 stents farmacológicos (CypherTM, 89%; TaxusTM, 7,5%; Xience V TM/PromusTM, 3%; EndeavorTM, 0,33%; BiomatrixTM, 0,2%) e incluídos neste estudo. O seguimento clínico de até 7 anos (mediana, 2,8 anos) foi completo em 98%, sendo obtido com 1, 6 e 12 meses e, então, anualmente. Tivemos como objetivo determinar as taxas de eventos cardíacos adversos maiores (ECAM) ao longo do período do acompanhamento clínico. RESULTADOS: A média de idade foi de 64,5 ± 11,7 anos, com predomínio de pacientes do sexo masculino (76,7%). Diabetes melito foi encontrado em 31,6% dos casos e 9,8% eram portadores de insuficiência renal crônica. A artéria descendente anterior foi o vaso mais frequentemente tratado (43,4%) e dois terços das lesões eram de alta complexidade (B2/C). Sucesso angiográfico do procedimento foi obtido em 98,8% dos casos. A taxa de ECAM foi de 12,8% durante o seguimento, com 4,5% de óbito cardíaco, 4,2% de infarto agudo do miocárdio, 4,5% de nova revascularização da lesão-alvo e 1,5% de trombose do stent. CONCLUSÕES: No Registro DESIRE, o tratamento de vasos de pequeno calibre com stents farmacológicos, em pacientes não-selecionados, associou-se a excelentes resultados agudos e tardios, e a baixas taxas de trombose ao longo da evolução.

INTRODUÇÃO: O sangramento associado à intervenção coronária percutânea (ICP) é uma complicação frequente e muitas vezes negligenciada quanto a sua importância prognóstica. Diversos estudos têm demonstrado o impacto clínico adverso do sangramento, principalmente no aumento da mortalidade a curto e longo prazos. O objetivo deste estudo é avaliar os preditores e o impacto clínico do sangramento em uma grande coorte contemporânea de pacientes submetidos a ICP. MÉTODOS: Avaliamos 2.892 pacientes consecutivos submetidos a ICP eletiva ou de urgência, entre janeiro de 2008 e junho de 2009, em um centro de referência para a realização do procedimento. Foram comparados os grupos que apresentaram ou não sangramento em relação às variáveis clínicas, angiográficas e relacionadas à intervenção, bem como a evolução clínica intrahospitalar. Regressão logística múltipla foi realizada com a finalidade de determinar o grau de influência e independência dos fatores preditores de sangramento. RESULTADOS: A incidência de sangramento periprocedimento foi de 1,7%. Considerando-se apenas os pacientes com síndrome coronária aguda (SCA), a incidência elevou-se para 3,4%. A análise multivariada identificou, como fatores independentes de sangramento, SCA [odds ratio (OR) 3,96, intervalo de confiança de 95% (IC 95%) 1,45-11,42], utilização de inibidores de glicoproteína IIb/IIIa (OR 2,55, IC 95% 1,68-3,87), insuficiência renal crônica (OR 2,34, IC 95% 1,11-3,49), Killip IV (OR 2,32, IC 95% 1,54-3,5) e acesso vascular por via femoral (OR 1,72, IC 95% 1,19-3,14). O sangramento periprocedimento foi associado com insuficiência renal aguda (16,7% vs. 1,6%; P < 0,001) e mortalidade no período intra-hospitalar (10,4% vs. 0,7%; P < 0,001). CONCLUSÕES: O presente estudo demonstra que o sangramento periprocedimento, mais frequentemente observado em pacientes com SCA, é preditor de eventos clínicos adversos maiores no período intra-hospitalar, incluindo maior mortalidade. BACKGROUND: Percutaneous coronary intervention (PCI)related bleeding is a frequent complication whose prognosis is often neglected. Several studies have shown the adverse clinical impact of bleeding, especially increased short and long-term mortality rates. The purpose of this study was to evaluate predictors and clinical impact of this complication in a large cohort of patients undergoing PCI. METHODS: We performed a prospective analysis of 2,892 consecutive patients undergoing elective or urgent PCI from January/2008 to June/2009. Patients with and without bleeding were compared for clinical, angiographic and procedure-related variables as well as in-hospital clinical outcomes. Multiple logistic regression analysis was performed to determine the influence and independence of bleeding predictors. RESULTS: Procedure-related bleeding was identified in 1.7% of the patients. Taking in account only patients with acute coronary syndrome (ACS) the incidence increased to 3.4%. Multivariate analysis identified ACS [odds ratio (OR) 3.96, 95% confidence interval (95% CI) 1.45-11.42], use of glycoprotein IIb/IIa inhibitors (OR 2.55, 95% CI 1.68-3.87), chronic renal failure (OR 2.34, 95% CI 1.11-3.49), Killip IV (OR 2.32, 95% CI 1.54-3.5) and femoral access (OR 1.72, 95% CI 1.19-3.14) as independent predictors of bleeding. Procedure-related bleeding was associated with in-hospital acute renal failure (16.7% vs. 1.6%; P < 0.001) and in-hospital mortality (10.4% vs. 0.7%; P < 0.001). CONCLUSIONS: The present study demonstrates that periprocedural bleeding, more frequently observed in patients with ACS, is a predictor of in-hospital major clinical adverse events, including increased mortality rates.

INTRODUÇÃO: Estudos recentes incluindo pacientes portadores de doença coronária estável sugerem ausência de benefício clínico da estratégia inicial de intervenção coronária percutânea com stents não-farmacológicos associada a terapia medicamentosa otimizada vs. terapia medicamentosa otimizada isolada. No entanto, o tratamento ideal para pacientes com doença coronária estável no mundo real permanece controverso. Reportamos o impacto dos stents farmacológicos (SF) em pacientes portadores de doença coronária estável tratados na prática clínica diária. MÉTODO: Entre maio de 2002 e novembro de 2009, 1.814 pacientes portadores de doença coronária estável (angina estável ou isquemia silenciosa) foram prospectivamente incluídos no Registro DESIRE, e o seguimento clínico de até 8 anos (média de 3,9 ± 2 anos) foi realizado em 98% desses pacientes. RESULTADOS: A média das idades era de 64,2 ± 10,8 anos, 28% tinham diabetes melito, 21% tinham infarto do miocárdio prévio e 51,7%, revascularização prévia. A artéria descendente anterior foi o vaso-alvo mais tratado (42%), e, considerando-se o total de lesões (n = 2.701), 66,3% delas eram de elevada complexidade (tipos B2/C). Ao final do procedimento, o sucesso angiográfico foi de 99%. No seguimento clínico tardio, as taxas cumulativas de eventos adversos foram: morte cardíaca, 3,4%; infarto do miocárdio, 5,5%; revascularização da lesão-alvo (RLA), 4,8%; e trombose de stent, 0,8%. CONCLUSÃO: A utilização de SF na doença coronária estável esteve associada a excelente evolução clínica tardia, incluindo taxa cumulativa de RLA < 5%, e segurança sustentada. Comparados a dados históricos, tais achados demonstram grande benefício dos SF nessa população, sugerindo que a intervenção coronária percutânea com SF pode ser uma alternativa inicial segura e eficaz no tratamento de pacientes com doença coronária estável. BACKGROUND: Recent studies in patients with stable coronary artery disease suggest there is no clinical benefit of the initial strategy of percutaneous coronary intervention with bare metal stents associated to optimal medical therapy (OMT) vs OMT alone. However, the best therapeutic option for patients with stable coronary artery disease in the real world remains controversial. We report the impact of drug eluting stents (DES) in patients with stable coronary artery disease treated in the daily clinical practice. METHOD: From May 2002 to November 2009, 1,814 patients with stable coronary artery disease (stable angina or silent ischemia) were prospectively included in the DESIRE Registry and 98% of the patients were followed up to 8 years (mean 3.9 ± 2 years). RESULTS: Mean age was 64.2 ± 10.8 years, 28% had diabetes mellitus, 21% had a prior myocardial infarction and 51.7% had a prior revascularization. Left anterior descending artery was treated in 42% of the patients. When all of the lesions (n = 2,701) were taken into consideration, 66.3% were classified as complex B2/C lesions. Angiographic success was 99%. The cumulative rate of adverse events in the late clinical follow-up was: cardiac death, 3.4%; myocardial infarction, 5.5%; target-lesion revascularization (TLR), 4.8%; and stent thrombosis, 0.8%. CONCLUSION: The use of DES in stable coronary artery disease was associated to excellent late clinical follow-up including a cumulative TLR rate < 5% and stent thrombosis < 1%. When compared to historical data, such findings show a great benefit of DES in this population, suggesting that percutaneous coronary intervention with DES is a safe and effective initial strategy in patients with stable coronary artery disease.

INTRODUÇÃO: A reestenose intrastent (RIS), resultante da excessiva resposta reparadora neointimal após o implante da prótese, é uma das principais limitações da intervenção coronária percutânea. A despeito da eficácia dos stents farmacológicos (SF) de primeira geração no tratamento da RIS, questões relacionadas à segurança e ao perfil de flexibilidade/navegabilidade dessas próteses estimularam o desenvolvimento de novas gerações de SF. O novo SF FirebirdTM (Microport Co. Ltd., Xangai, China) combina uma plataforma de aço inoxidável (316 L) de hastes finas (0,0040 polegada), um potente agente antiproliferativo (sirolimus, na dose de 9 µg/mm²) e um revestimento que inclui três camadas de polímero durável, que controla a liberação do fármaco. Apesar de ser um dos SF mais utilizados na China, pouco se conhece sobre seu desempenho, sobretudo em subgrupos de maior complexidade. MÉTODO: Entre fevereiro e dezembro de 2009, pacientes portadores de lesão reestenótica única, de stents não-farmacológicos, foram submetidos a intervenção coronária percutânea com implante de stent FirebirdTM. Avaliação com angiografia e ultrassom intracoronário (USIC) foi programada para todos os pacientes aos 12 meses de seguimento. O desfecho primário foi a perda luminal tardia (QCA) e o porcentual de obstrução volumétrica intrastent (USIC) aos 12 meses. RESULTADOS: Foram incluídos 25 pacientes com média de idade de 56,8 ± 7,7 anos, 80% dos quais eram do sexo masculino e 40%, diabéticos. A artéria descendente anterior foi o vaso mais frequentemente tratado (44%) e a maioria das lesões era do tipo difuso/proliferativo (64%). Aos 12 meses, a perda luminal tardia foi de 0,3 ± 0,24 mm, não tendo sido identificado nenhum caso de reestenose binária. Ao USIC, o porcentual de obstrução volumétrica intrastent foi de 2,6 ± 1,9%. CONCLUSÃO: Neste estudo unicêntrico, o novo SF FirebirdTM demonstrou resultados angiográficos e ultrassonográficos favoráveis para o tratamento da RIS de stents não-farmacológicos, no acompanhamento de um ano. BACKGROUND: In-stent restenosis (ISR), resulting from excessive neointimal hyperplasia, is a major limitation of percutaneous coronary intervention. Despite the efficacy of first generation drug-eluting stents (DES) in the treatment of ISR, issues related to the safety and flexibility/navigability profile have encouraged the development of new generations of DES. The new FirebirdTM DES (Microport Co. Ltd., Shanghai, China) combines a stainless steel platform (L316) of fine struts (0,0040'), a powerful anti-proliferative agent (sirolimus, at a dose of 9 µg/mm²) and a coating that includes three layers of a durable polymer, which controls drug release. Though it is a most used DES in China, little is known about its performance, particularly in subgroups of greater complexity. METHOD: Between February and December 2009, patients with single bare metal stent restenotic lesions, were submitted to percutaneous coronary intervention with FirebirdTM stent implantation. Angiography and intravascular ultrasound (IVUS) were scheduled for all patients at 12 months of follow-up. The primary end-point was late loss and the percentage of in-stent volumetric obstruction at 12 months. RESULTS: Twenty-five patients with mean age of 56.8 ± 7.7 years were included, of which 80% were males and 40% diabetics. The anterior descending artery was the most frequently treated vessel (44%) and most lesions had a diffuse/proliferative pattern (64%). At 12 months, late luminal loss was 0.3 ± 0.24 mm, and no case of binary restenosis was identified. IVUS percent volumetric obstruction was 2.6 ± 1.9%. CONCLUSION: In this single center study, the new FirebirdTM DES showed favorable angiographic and IVUS results for the treatment of bare metal ISR at the one year follow-up.

Even though sirolimus-eluting stents (SES) have been shown to significantly improve binary restenosis and target lesion revascularisation rates (TLR) compared to bare metal stents in diabetic patients, the revascularisation rate is still higher than those of non-diabetics. Whether a double dose (DD) of sirolimus on a stent would provide a greater reduction in neointimal hyperplasia compared to single dose (SD) SES in de novo coronary lesion of diabetic patients is unknown.A total of 56 patients (58 lesions) were prospectively randomised in a double blind fashion in a 1:1 ratio to SD (30 lesions) versus DD (28 lesions). Procedure success was achieved in all patients. QCA results at 6 months were comparable between groups, including the primary endpoint of in-stent late lumen loss (0.19+/-0.29 mm in SD versus 0.18+/-0.33 mm in DD, p=0.96). Furthermore, restenosis was not found inside the stent in either group. By IVUS, there was no late/acquired incomplete stent apposition at follow-up, and% neointimal volume was 2.2+/-1.8% in SD versus 1.7+/-2.0% in DD, p=0.44. At 1-year clinical follow-up, there was no significant difference between groups for major events, including TLR which occurred in 1 patient in SD versus 3 patients in DD, p=0.61. Overall, there was only 1 subacute stent thrombosis (DD arm), and no late thromboses.Double dose SES did not improve the prevention of neointimal proliferation in diabetic patients with de novo coronary lesion compare to single dose SES.

INTRODUÇÃO: O remodelamento vascular positivo após intervenção coronária percutânea com stents farmacológicos pode estar associado a dose excessiva do fármaco antiproliferativo e/ou toxicidade local do polímero sintético. Tal fenômeno pode levar à aposição incompleta tardia das hastes do stent, atuando como fator de risco para trombose tardia/muito tardia. Objetivamos avaliar a resposta vascular secundária ao implante de stents liberadores de sirolimus com diferentes doses e formas de eluição por meio de análise seriada com ultrassom intracoronário. MÉTODO: Avaliamos 50 pacientes de baixo a moderado risco cardiovascular divididos em três grupos, de acordo com a dose de sirolimus e a forma de eluição: grupo 1, Cypher® (7,7 µg de sirolimus/mm de stent, polímero durável); grupo 2, Cypher Redox® (3,1 µg de sirolimus/mm de stent, polímero durável); e grupo 3, VESTAsyncTM (2,9 µg de sirolimus/mm de stent, sem polímero). RESULTADOS: No seguimento de 10 ± 1 meses, os stents Cypher®, Redox® e VESTAsyncTM apresentaram perda luminal tardia, respectivamente, de 0,16 ± 0,36 mm, 0,24 ± 0,33 mm e 0,37 ± 0,24 mm (P = 0,19). Na análise com ultrassom intracoronário, os stents Cypher® e Redox® apresentaram discreto remodelamento vascular positivo, traduzido pelo aumento não-significativo do volume do vaso de 0,1 ± 1,6 mm³/mm e 0,5 ± 0,6 mm³/mm, respectivamente. Por outro lado, o grupo VESTAsyncTM apresentou ausência de remodelamento vascular positivo (-0,3 ± 1,9 mm³/mm). CONCLUSÕES: Na população avaliada, não foi observada relação linear entre doses crescentes de sirolimus e remodelamento vascular positivo, sugerindo que esse fenômeno vascular pode estar relacionado à presença de um polímero sintético.

INTRODUÇÃO: A presença de polímeros sintéticos em contato com a parede vascular tem sido associada a intensa resposta inflamatória local e a eventos adversos tardios. Entretanto, sua ausência pode comprometer a eficácia dos stents farmacológicos em suprimir a hiperplasia intimal. Avaliamos, com angiografia coronariana quantitativa (ACQ) e ultrassom intracoronariano (USIC), a eficácia do stent VestasyncTM (VES), liberador não-polimérico de sirolimus em baixa dose (55 µg), e do stent CypherTM (CYP), liberador de sirolimus polimérico em alta dose (140 µg). MÉTODO: Quinze pacientes com lesões primárias < 14 mm, em artérias coronárias nativas de 2,5 mm a 3,5 mm, foram tratados com VES e comparados a uma coorte histórica de 15 pacientes tratados com CYP. ACQ e USIC foram realizados pós-procedimento, aos 4 e 12 meses. Desfechos primários foram: perda tardia intrastent e porcentual de obstrução volumétrica intrastent. RESULTADOS:As características clínicas eram semelhantes. O grupo VES tinha vasos menores (2,67 ± 0,32 mm vs. 2,98 ± 0,4 mm; P = 0,02). Aos 4 meses, o grupo VES mostrou tendência a maior perda tardia intrastent (0,30 ± 0,25 mm vs. 0,10 ± 0,3 mm; P = 0,06), mas porcentual de obstrução volumétrica intrastent similar ao do grupo CYP (2,8 ± 2,2% vs. 2,2 ± 3,8%; P = 0,60). Aos 12 meses, a perda tardia intrastent foi de 0,37 ± 0,24 mm no grupo submetido a implante de stent VES vs. 0,16 ± 0,36 mm no grupo submetido a implante de stent CYP (P = 0,074), e o porcentual de obstrução volumétrica intrastent foi de 4,0 ± 2,2% no grupo que recebeu stent VES vs. 2,4 ± 3,9% no grupo que recebeu stent CYP (P = 0,17). Não houve casos de reestenose binária. CONCLUSÕES: O stent VES mostrou-se seguro e eficaz em suprimir a hiperplasia intimal até 12 meses. Ausência do polímero e dosagem reduzida da droga não comprometeram sua eficácia. Estudos maiores e com seguimento mais longo são necessários para avaliar se esses achados melhorarão o perfil de segurança dos stents farmacológicos. BACKGROUND: The long-term presence of the stent polymer in contact with the vessel wall has been associated to intense inflammatory response and late adverse events. However, absence of the stent polymer may compromise drug dose and drug delivery kinetics, leading to some efficacy issues. We aimed to compare, by means of serial quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS), the efficacy of the novel nonpolymeric low-dose (55 µg) VESTAsyncTM (VES) sirolimus-eluting stent, with the permanent polymer, high-dose (140 µg) CypherTM sirolimus-eluting stent (CYP). METHODS: Fifteen patients with single, de novo lesions < 14 mm, in native vessels of 2.5 mm to 3.5 mm diameter, were treated with VES and compared to a paired historical cohort of 15 patients treated with CYP. QCA and IVUS data were obtained post-procedure and at 4 and 12-month follow-up. Primary endpoints were the comparison of in-stent late luminal loss and percentage of intimal hyperplasia obstruction. RESULTS: Clinical characteristics were similar between groups. The VES group had smaller vessels (2.67 ± 0.32 mm vs. 2.98 ± 0.4 mm; P = 0.02). At 4 months, the VES group had a tendency towards a higher in-stent late luminal loss (0.30 ± 0.25 mm vs. 0.10 ± 0.3 mm; P = 0.06) but similar IVUS % of intimal hyperplasia obstruction (2.8 ± 2.2% vs. 2.2 ± 3.8%; P = 0.60). At 12-months, in-stent late luminal loss was 0.37 ± 0.24 mm (VES) vs. 0.16 ± 0.36 mm (CYP), P = 0.074, and the IVUS % of intimal hyperplasia obstruction was 4.0 ± 2.2% (VES) vs. 2.4 ± 3.9% (CYP), P = 0.17. There were no cases of binary restenosis. CONCLUSION: The VES proved safe and effective in reducing intimal hyperplasia formation up to 12 months. The absence of the polymer, as well as the lower drug dose, did not impact the efficacy of this device. Whether these changes will affect the safety profile of this novel DES has to be confirmed in a larger cohort of patients and longer follow up.

INTRODUÇÃO: Os stents eluidores de everolimus mostraramse seguros e eficazes em estudos randomizados com pacientes selecionados e de baixa complexidade clínica e angiográfica. No entanto, estudos que avaliam seu impacto em pacientes mais complexos da prática clínica corrente são escassos. MÉTODO: No total, foram avaliados, prospectivamente, 193 pacientes tratados apenas com stents eluidores de everolimus. Os únicos critérios de exclusão foram reestenose de outro stent farmacológico, intervenção em enxertos de veia safena, e infarto agudo do miocárdio com elevação do segmento ST. O desfecho primário foi a ocorrência de eventos cardíacos adversos maiores, definidos como a combinação de morte de origem cardíaca, infarto do miocárdio e revascularização do vaso-alvo. RESULTADOS: A média das idades foi de 60,6 ± 11,8 anos. Metade da população era do sexo feminino e 36,8% eram portadores de diabetes. Doença multiarterial estava presente em 61,6% dos pacientes. Foi tratada 1,8 ± 0,66 lesão em 1,73 ± 0,9 vaso, com 2,27 ± 0,9 stents por paciente. A maioria das lesões (70,6%) era do tipo B2/C, bifurcações verdadeiras foram tratadas em 37,3% dos casos e calcificação moderada a grave estava presente em 17,4% das lesões. Eventos cardíacos adversos maiores ocorreram em 6,7% dos pacientes ao final de um ano, principalmente à custa de eventos da fase hospitalar. Houve apenas um caso (0,5%) de trombose subaguda provável do stent. Não houve casos de trombose tardia. CONCLUSÕES: A presente análise sugere que o uso de stents eluidores de everolimus é seguro e eficaz em pacientes complexos da prática clínica diária, com baixas taxas de eventos cardíacos adversos maiores até o final do primeiro ano. Seguimento mais longo e com maior número de pacientes é necessário para confirmação desses resultados promissores.

INTRODUÇÃO: Embora os stents farmacológicos (SF) tenham se mostrado superiores aos não-farmacológicos (SNF) em reduzir reestenose, não está ainda totalmente definida a segurança desses instrumentais quando utilizados para tratar lesões mais complexas. Objetivamos determinar os desfechos clínicos bastante tardios de pacientes tratados com SF para indicações off-label. MÉTODO: Incluímos nesta análise os pacientes consecutivos tratados apenas com SF, entre maio de 2002 e janeiro de 2008, em uma única instituição. Foram excluídos pacientes que receberam SF e SNF no mesmo procedimento, aqueles tratados em fase aguda do infarto agudo do miocárdio (IAM) e os que apresentavam lesões em pontes de safena. Os pacientes foram divididos em dois grupos, conforme a indicação para uso do stent: grupo on-label, pacientes com lesão única, de novo, em vaso de calibre entre 2,5 mm e 3,5 mm, com lesões que não excedessem 30 mm em extensão no caso do stent CypherTM e 28 mm quando o SF utilizado fosse o TaxusTM; e grupo off-label, que incluiu os demais pacientes. Os desfechos primários avaliados foram: ocorrência de óbito cardíaco, IAM e trombose no longo prazo (> 1 ano). RESULTADOS: A maioria dos pacientes tratados era do grupo off-label [1.702 (78,5%) pacientes de 2.167]. O seguimento clínico completo foi obtido em 98,3% da população. Os pacientes do grupo off-label apresentaram maiores taxas de óbito cardíaco (3,0% vs. 2,6%; P = 0,037), IAM (4,1% vs. 2%; P = 0,005) e trombose do stent (1,9% vs. 0,6%; P = 0,021), porém com taxas equivalentes de nova revascularização da lesão-alvo. CONCLUSÕES: Neste registro, o uso de SF em situações de elevada complexidade angiográfica associou-se a baixas taxas de eventos adversos maiores (< 11%) e trombose de stent (< 2%). Entretanto, quando comparados aos pacientes de menor complexidade, essa população apresentou pior evolução tardia. BACKGROUND: Although superior to bare metal stents (BMS) in reducing restenosis, drug-eluting stents (DES) long-term safety, especially after being deployed to treat complex lesions, has not been completely established. We sought to evaluate very late clinical outcomes of DES in the off-label scenario. METHODS: Between May 2002 and January 2008 all consecutive patients treated solely with DES were prospectively enrolled in the single center DESIRE registry. Patients with acute myocardial infarction and saphenous vein grafts were excluded. Patients were divided into two groups, according to their "label" status: on-label group, patients with a single de novo lesion located in a native coronary artery of 2.5 to 3.5 mm in diameter and < 28 mm (Taxus®) or < 30 mm (Cypher®) in length. The off-label group included the remaining patients. Our primary objective was to compare the long-term (> 1 year) incidence of cardiac death, non-fatal myocardial infarction (MI) and stent thrombosis (ST) between the 2 groups. RESULTS: Most of the enrolled patients were off-label [1,702 (78.5%) patients of 2,167]. Complete follow-up data were obtained in 98.3% of the cases. off-label patients presented a higher incidence of cardiac death (3.0% vs. 2.6%; P = 0.037), MI (4.1% vs. 2.0%; P = 0.005) and ST (1.9% vs. 0.6%; P = 0.021). Need for repeat lesion revascularization was similar between groups. CONCLUSION: In the DESIRE registry, DES in patients with a very complex profile was associated with low rates of major adverse cardiac events (< 11%) and ST (< 2.0%) up to 6-year follow-up; however, the outcomes in this subset are still inferior compared to those with strict indications for DES.

INTRODUÇÃO: Com o aumento da longevidade da população, as intervenções coronárias percutâneas (ICP) em octogenários têm sido realizadas com frequência crescente. No entanto, como os pacientes vivem mais, possivelmente apresentar-se-ão ao cardiologista com doença mais avançada, tanto em relação às comorbidades como à própria coronariopatia, fato que, se confirmado, poderia influenciar os resultados almejados. MÉTODO: Estudo de coorte, retrospectivo, com o objetivo de avaliar se houve mudanças nos perfis clínico e angiográfico de octogenários tratados por meio de ICP numa fase mais atual (biênio 2006/2007), em comparação com o período 2002/2003. Os pacientes foram identificados a partir de um banco de dados informatizado, no qual eram incluídos de forma prospectiva e divididos em dois grupos: grupo A, 128 pacientes tratados no biênio 2006/2007; e grupo B, 98 pacientes dilatados no biênio 2002/2003. Não foram estabelecidos critérios de inclusão e exclusão. Consideraram-se significantes valores de P < 0,05. RESULTADOS: Os 128 pacientes do grupo A corresponderam a 4,7% das ICP realizadas em 2006/2007, enquanto os 98 casos do grupo B corresponderam a 3,7% das dilatações de 2002/2003 (P = 0,07). Predominaram significativamente no grupo A: ICP em pacientes renais crônicos (28,1% vs. 10,2%; P = 0,008) e uso de stents com diâmetro < 2,5 mm (27,7% vs. 8,2%; P = 0,0001). Notamos tendência para tratar maior número de pacientes com doença multiarterial (60% vs. 49%; P = 0,12) e lesões reestenóticas (6,7% vs. 1%; P = 0,09). O sucesso do procedimento foi similar entre os grupos (93,8% vs. 94,9%, nos grupos A e B, respectivamente; P > 0,99). CONCLUSÕES: 1) Houve tendência do aumento de octogenários tratados mais recentemente; e 2) os casos dilatados no biênio 2006/2007 apresentaram perfil clínico/angiográfico de maior risco, em especial para o desenvolvimento de reestenose coronariana. INTRODUCTION: As population longevity increases, percutaneous coronary interventions (PCI) in eighty-year-old individuals have been increasingly more performed. However, as patients live longer, they are likely to be referred to the cardiologist with a more advanced disease, both in terms of comorbidities and coronary disease, which might influence the desired results. METHOD: Retrospective cohort study aimed at assessing whether there have been changes in the clinical and angiographic profile of eighty-year-old individuals treated by PCI at a more recent period (2006/2007) compared to the 2002/2003 period. Patients were prospectively identified and included using a computerized database and were divided into two groups: group A, 128 patients treated in 2006/2007; and group B, 98 patients treated in 2002/2003. There were no inclusion and exclusion criteria. P < 0.05 was considered statistically significant. RESULTS: The 128 patients in group A corresponded to 4.7% of PCI performed in 2006/2007, whereas the 98 cases in group B corresponded to 3.7% of PCI in 2002/2003 (P = 0.07). In group A, PCI in chronic renal patients (28.1% vs. 10.2%; P = 0.008) and the use of stents < 2.5 mm (27.7% vs. 8.2%; P = 0.0001) were statistically significant. There was a trend to treat a larger number of patients with multiartery disease (60% vs. 49%; P = 0.12) and restenotic lesions (6.7% vs. 1%; P = 0.09). The procedure success rate was similar between groups (93.8% vs. 94.9%, respectively; P > 0.99). CONCLUSIONS: 1) There was a trend in the increase of eighty-year-old individuals treated more recently; 2) cases dilated in 2006/2007 had a higher clinical/angiographic risk profile, specially for the development of coronary restenosis.

We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 microg).Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology.A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter andor=14-mm length were enrolled in this first-in-man study. Primary end point was in-stent late lumen loss (LL) at 4 and 9 months.Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 +/- 0.3 mm and 10 +/- 2.0 mm, respectively. Procedure success was obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 +/- 0.25 mm and 2.6 +/- 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 +/- 0.23 mm and 4.0 +/- 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition. There were no major adverse cardiac events within 1 year of follow-up.The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.

Background: Recently, cardiologists have treated more complex patients and lesions with drug-eluting stents (DES). However, long-term efficacy and safety of the off-label use of these new devices is yet to be demonstrated. Methods: The Drug-Eluting Stents in the Real World (DESIRE) registry is a prospective, nonrandomized single-center registry with consecutive patients treated solely with DES between May 2002 and May 2007. The primary end-point was long-term occurrence of major adverse cardiac events (MACE). Patients were clinically evaluated at 1, 3, and 6 months and then annually up to 5 years. Results: A total of 2,084 patients (2,864 lesions and 3,120 DES) were included. The mean age was 63.8 ± 11.5 years. Diabetes was detected in 28.9% and 40.7% presented with acute coronary syndrome. Cypher™ was the predominant DES in this registry (83.5%). Mean follow-up time was 2.6 ± 1.2 years and was obtained in 96.5% of the eligible patients. Target lesion revascularization (TLR) was performed in 3.3% of the patients. Q wave myocardial infarction (MI) occurred in only 0.7% of these patients and total stent thrombosis rate was 1.6% (n = 33). Independent predictors of thrombosis were PCI in the setting of MI (HR 11.2; 95% CI, 9.6–12.4, P = 0.001), lesion length (HR 4.6; 95% CI, 3.2–5.3, P = 0.031), moderate to severe calcification at lesion site (HR 13.1; 95% CI, 12.1–16.7, P < 0.001), and in-stent residual stenosis (HR 14.5; 95% CI, 10.2–17.6, P < 0.001). Conclusion: The use of DES in unselected population is associated with long-term safety and effectiveness with acceptable low rates of adverse clinical events.

We sought to investigate the performance and efficacy of the third-generation polymer-free Vestasync-eluting stent (VES).Recent concerns regarding the long-term safety of drug-eluting stents have been raised. Synthetic polymers have been associated with intensive inflammatory response and late stent thrombosis. Newly developed, the VES combines a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free sirolimus formulation (55 mum).In May 2007, 15 patients with single de novo lesion located in native coronary arteries 3.0 to 3.5 mm in diameter andor =14 mm in length were consecutively enrolled. Primary end points included in-stent late lumen loss and in-stent percent of obstruction at 4 months. Serial angiography and intravascular ultrasound were obtained at the index procedure and repeated at 4-month follow-up.Mean population age was 63.8 years; 33% of patients were diabetic. The left anterior descending artery was the prevalent target vessel (47%). Reference vessel diameter and lesion length were 2.67 +/- 0.32 mm and 9.98 +/- 1.98 mm, respectively. The VES was successfully implanted in all cases, and there were no procedure and in-hospital complications. Life-long aspirin and 6-month clopidogrel therapy were prescribed for all patients. At 4 months, in-stent late lumen loss was 0.30 +/- 0.25 mm and percent of stent obstruction was 2.8 +/- 2.2%. After up to 6 months of clinical follow-up, no major adverse cardiac event was registered.The third-generation VES demonstrated excellent acute results in the treatment of de novo coronary lesions. Longer follow-up with a more complex subset of patients and lesions is required to confirm these preliminary results.

FUNDAMENTOS: Disturbios de fluxo coronario decorrentes de embolizacao de fragmentos de ateroma/trombo estao associados a pior prognostico apos intervencao coronaria percutânea (ICP). A abordagem de lesoes em pontes de safena (PS) e no cenario de sindromes coronarias agudas (SCA) esta frequentemente associada a essas complicacoes. Apesar de dispositivos de protecao embolica terem demonstrado seu valor na prevencao desses eventos, estes adicionam tempo e custo a ICP, alem de terem seu uso limitado as PS. Recem-desenvolvido, o stent MGuard® combina uma malha microscopica presa as hastes de um stent nao-farmacologico, conferindo baixo perfil a esse dispositivo. OBJETIVOS: Avaliar a eficacia e a seguranca do stent MGuard® por meio de desfechos clinicos e angiograficos. METODO: Estudo unicentrico com 19 pacientes portadores de lesoes de novo em PS ou lesoes com caracteristicas angiograficas de instabilidade em coronarias nativas. O desfecho primario incluiu a taxa de eventos cardiacos adversos maiores (ECAM) em trinta dias. RESULTADOS: A apresentacao clinica em 60% dos casos era de SCA e em 55% dos pacientes a lesao encontrava-se em PS. O stent MGuard® foi implantado com sucesso em todos os casos, alcancando fluxo TIMI 3/blush 3 ao final de todas as ICPs, nao sendo observadas complicacoes angiograficas. Nao foram registradas elevacoes de CK-MB maiores que tres vezes o valor de referencia pos-ICP ou ECAM em trinta dias. CONCLUSOES: Nesta avaliacao preliminar, o stent MGuard® demonstrou alta eficacia num grupo de pacientes com alta complexidade angiografica (sem uso adjunto de dispositivos de protecao embolica). Seguimento angiografico de seis meses e uma amostra maior de pacientes sao necessarios para confirmar tais achados.

FUNDAMENTOS: Historicamente, as intervencoes coronarias percutâneas (ICP) em lesoes de bifurcacao associam-se com elevadas taxas de complicacoes, principalmente em decorrencia dos resultados subotimos no ramo lateral (RL) e da necessidade de revascularizacao da lesao-alvo (RLA) durante seguimento tardio. Avaliamos o impacto dos stents farmacologicos (SF) na evolucao clinica tardia de pacientes nao-selecionados provenientes da pratica clinica diaria com lesao envolvendo bifurcacao. METODO: A partir de maio de 2002, 195 pacientes com lesao de bifurcacao foram consecutivamente tratados em dois centros clinicos (grupo SF = 89 pacientes; grupo stent nao-farmacologico [SNF] = 106), e o seguimento clinico foi completo ate dois anos. RESULTADOS: Os dois grupos apresentavam perfis clinicos semelhantes, incluindo media das idades de 63 anos, e 25% de diabetes melito. A maioria das lesoes tinha comprometimento significativo dos dois ramos (78% vs. 76%; p = 0,82), a estrategia de stent provisional RL foi utilizada na maioria dos casos (75% vs. 89% de SNF; p = 0,45), e o sucesso angiografico no RL (fluxo TIMI 3, estenose residual < 50%, sem disseccao) foi atingido em 80% vs. 78% (p = 0,56), nos grupos SF e SNF, respectivamente. Aos 24 meses de seguimento, o grupo SF apresentou maior sobrevida livre de RLA (97,8% vs. 82,1%; p < 0,0001), com consequente maior sobrevida livre de eventos cardiacos adversos maiores (ECAM) (93,3% vs. 77,4%; p = 0,003). A trombose de stent ocorreu em 2 pacientes em cada grupo. CONCLUSOES: Em pacientes naoselecionados do "mundo-real", o uso de SF para o tratamento de lesoes coronarias em bifurcacao mostrou-se significantemente superior ao uso de SNF no seguimento clinico tardio, em especial no que se refere a efetividade clinica em reduzir as taxas de RLA, com consequente aumento na sobrevida livre de ECAM, sem o comprometimento de sua seguranca tardia.

INTRODUÇÃO: A doença carotídea aterosclerótica (DCA) é responsável por 40% dos acidentes vasculares cerebrais (AVC). Apesar de a intervenção carotídea percutânea (ICP) ser uma alternativa à endarterectomia, ainda há poucos dados disponíveis comparando a ICP em pacientes assintomáticos (PAS) versus sintomáticos (PS). O objetivo desta análise foi avaliar essa questão em um grupo consecutivo de pacientes. MÉTODO: Foram realizadas 262 ICP em 230 pacientes consecutivos, 61 (26,5%) PAS versus 169 (73,5%) PS. A angiografia carotídea quantitativa (ACQ) foi realizada pré e pós-procedimento e o seguimento clínico, na fase hospitalar e aos 6 e 12 meses. RESULTADOS: As características demográficas foram similares entre os dois grupos, sendo 31% diabéticos. Obtivemos sucesso primário em 100% dos casos, com ausência de complicações maiores em ambos os grupos. Na análise com ACQ, o diâmetro de estenose foi maior no grupo PAS (83,4 ± 7,6% vs. 74,9 ± 12,5%; p < 0,01), mas o grupo PS apresentou lesões mais longas (18,3 ± 5,7% vs. 21,7 ± 7,4%; p < 0,01). Aos 30 dias, não houve diferença na incidência de AVC maior (1,8 vs. 2,0%; p = 0,45) ou menor (0 vs. 1,4%; p = 0,19) entre os grupos PAS e PS, respectivamente. Entre 1-12 meses, não houve casos de AVC adicionais em ambos os grupos. Constatou-se somente um caso tardio de revascularização da lesão-alvo no grupo PS e nenhuma morte de causa neurológica foi observada tanto no grupo PAS como no grupo PS. CONCLUSÃO: A ICP é uma técnica segura e eficaz, com baixa incidência de complicações aos 30 dias e 12 meses. A incidência de óbito, AVC e revascularização da lesão-alvo foi similar entre os dois grupos. BACKGROUND: Carotid atherosclerotic disease (CAD) is responsible for 40% of strokes. Despite percutaneous carotid intervention (PCI) is an alternative to endarterectomy, there is little data available comparing the PCI in asymptomatic vs. symptomatic patients. The purpose of this analysis was to evaluate this issue in a consecutive group of cases. METHODS: 262 PCIs were conducted on 230 consecutive patients, 61 (26.5%) in asymptomatic vs. 169 (73.5%) in symptomatic patients. Quantitative carotid angiography (QCA) was performed before and after the procedure and the clinical follow-up obtained in-hospital and at 6 and 12 months. RESULTS: The demographic characteristics were similar between groups; 31% were diabetics. Primary success was obtained in all cases, with no major complications in both groups. QCA analysis revealed a higher diameter stenosis in asymptomatics (83.4% ± 7.6% vs. 74.9% ± 12.5%; p < 0.01), but symptomatic patients had longer lesions (18.3% ± 5.7% vs. 21.7% ± 7.4%; p < 0.01). At 30 days there was no difference in the incidence of major (1.8% vs. 2.0%; p = 0.45) or minor strokes (0 vs. 1.4%; p = 0.19) for both groups. Between 1 and 12 months there have been no additional strokes. A late target vessel revascularization was observed in symptomatic patients but no neurologic deaths in both groups. CONCLUSION: PCI is safe and effective, with low incidence of complications at 1 and 12 months. The incidence of death, stroke and target vessel revascularization was similar between groups.

INTRODUÇÃO: A intervenção coronária percutânea em vasos de fino calibre está associada a piores resultados imediatos e tardios, com elevadas taxas de reestenose, motivando o desenvolvimento de novos instrumentais para tal finalidade. OBJETIVO: Avaliar a exeqüibilidade, a eficácia e a segurança do novo sistema de stent CardioMindTM para o tratamento de lesões em vasos de fino calibre. MÉTODO: Dez pacientes portadores de lesões únicas, de novo, < 14 mm, em artérias coronárias nativas < 2,5 mm de diâmetro foram submetidos a implante do stent CardioMindTM. Todos os pacientes foram submetidos a angiografia e ultra-sonografia intracoronária (USIC) pósprocedimento e aos seis meses, com o desfecho primário de eficácia avaliado pela perda luminal tardia (PT) à angiografia e porcentagem (%) de obstrução do stent à USIC. RESULTADOS: A média das idades foi de 63 ± 10,6 anos, 60% dos pacientes eram do sexo feminino e 60%, diabéticos. O diâmetro de referência do vaso e a extensão da lesão foram de 2,06 ± 0,27 mm e 9,35 ± 1,39 mm, respectivamente. Sucesso do dispositivo e do procedimento foi obtido em todos os pacientes. Aos seis meses, a PT foi de 0,53 ± 0,60 mm e o volume de obstrução do stent à USIC, de 24,1 ± 8,7%. Um paciente apresentou reestenose binária, necessitando nova revascularização. Não houve óbitos e/ou infarto do miocárdio no acompanhamento clínico de seis meses. CONCLUSÕES: Este estudo piloto, com a utilização pela primeira vez em humanos do sistema de stent CardioMindTM em artérias coronárias de fino calibre, demonstrou ser esse stent factível e seguro, com resultados animadores na redução da hiperplasia intimal. O impacto clínico desses achados deve ser avaliado numa coorte maior de pacientes. BACKGROUND: Percutaneous coronary intervention in small vessels is associated to poor short and long-term results with high rates of restenosis, inducing the development of newer devices for this purpose. OBJECTIVE: To assess the feasibility, efficacy and safety of the new CardioMindTM stent system in the treatment of small vessel coronary artery disease (CAD). METHODS: Ten patients presenting a single, de novo lesion in a native coronary artery < 2.5 mm in diameter were assigned to receive the CardioMindTM stent. All patients were submitted to angiography and intravascular ultrasound (IVUS) evaluation immediately post-procedure and at 6 months. The primary end-point of efficacy was assessed by the late lumen loss at angiography and percentage (%) of neointimal obstruction at IVUS at 6 months. RESULTS: Mean age was 63 ± 10.6 years, 60% were female and 60% diabetics. Reference vessel diameter and lesion length were 2.06 mm ± 0.27 mm and 9.35 mm ± 1.39 mm, respectively. Device and procedure success were obtained in all patients. At 6-month, late loss was 0.53 mm ± 0.60 mm and % of neointimal obstruction by IVUS was 24.1% ± 8.7%. One patient presented binary restenosis requiring repeat percutaneous intervention. There were no cases of cardiac death and/or myocardial infarction. CONCLUSIONS: The CardioMindTM stent system showed to be viable and safe in this "First-In-Man" study of the use of this novel device in the treatment of small vessel CAD, with encouraging results in the reduction of in-stent late loss and neointimal formation. The clinical impact of these findings should be assessed in a larger cohort of patients.

INTRODUÇÃO: O tratamento percutâneo com cateter-balão e stents não-farmacológicos (SNF) de lesões na artéria descendente anterior (DA), quando comparado ao tratamento das outras artérias epicárdicas, freqüentemente cursa com taxas maiores de reestenose, comprometendo o resultado tardio da abordagem percutânea. OBJETIVO: Comparar a segurança e a eficácia tardia dos stents farmacológicos (SF) versus os SNF no tratamento de lesões únicas na DA. MÉTODO: Entre junho de 2002 e junho de 2003, 166 pacientes com lesão única em DA foram tratados com SF e comparados a uma coorte histórica de 141 pacientes tratados com SNF sob os mesmos critérios de inclusão/exclusão. Seguimento clínico tardio (aproximadamente dois anos) foi obtido em todos os pacientes. Objetivou-se comparar a taxa de eventos cardíacos adversos maiores (ECAM), definidos como morte cardíaca, infarto do miocárdio e revascularização da lesão-alvo (RLA), entre os dois grupos. RESULTADOS: Os grupos não diferiram quanto às características basais. O sucesso do procedimento foi obtido em todos os casos, não havendo eventos maiores na fase intra-hospitalar. Ao final de dois anos, 95,7% dos pacientes tratados com SF e 73,7% dos que receberam SNF estavam livres de ECAM (p < 0,0001). RLA ocorreu em 15,6% e 1,2% dos pacientes tratados com SNF e SF, respectivamente (p < 0,0001). Ainda que não significativa, a mortalidade cardíaca foi maior no grupo que recebeu SNF, comparativamente ao que recebeu SF (6,38% vs. 1,81%, respectivamente; p = 0,07). CONCLUSÃO: O implante de SF para o tratamento de lesões únicas na DA mostrou-se superior ao de SNF, reduzindo de forma significativa a taxa de ECAM, sobretudo a necessidade de nova RLA. INTRODUCTION: Percutaneous treatment (PCI) of single lesions in the LAD with balloon angioplasty or bare-metal stent (BMS) often have poorer outcomes when compared to PCI of lesions in the other major coronary arteries. OBJECTIVE: To compare the long term safety and efficacy of DES vs. BMS for the treatment of single lesions in the LAD. METHODS: Between June 2002 and June 2003, 166 patients with single lesions in the LAD were treated with DES and compared to a historic cohort of 141 patients treated with BMS under the same inclusion/exclusion criteria. Long term clinical follow-up (approximately 2 years) was obtained in all patients. The primary endpoint was the comparison of major adverse cardiac events (MACE) defined as cardiac death, non fatal MI and target-lesion revascularization (TLR) between the two groups. RESULTS: Baseline clinical characteristics did not differ between groups. Procedure success was achieved in all cases with no in hospital MACE. After two years of follow-up, 95.7% of patients treated with DES and 73.7% treated with BMS were free from any MACE (p < 0.0001). TLR occurred in 15.6% and 1.2% of the patients receiving BMS and DES respectively (p < 0.0001). Although not significantly reduced, cardiac death was less frequent among patients treated with these DES (6.38% vs. 1.81%, p = 0.07). CONCLUSION: The use of DES for the treatment of single LAD lesions was superior to BMS due to a marked reduction in MACE rates, mainly at the expense of a very low need for RLA.

FUNDAMENTO: As intervencoes percutâneas em pontes de safena (PS) apresentam menores taxas de sucesso angiografico e maior risco de complicacoes, pelo risco aumentado de embolizacao dos fragmentos da placa aterosclerotica friavel. Com o advento dos dispositivos de protecao distal, observou-se maior eficacia e seguranca do procedimento. Nosso objetivo foi comparar os stents MGuard® e SESAME®, dedicados ao tratamento de PS, nos primeiros 30 dias de evolucao. METODO: Estudo retrospectivo, comparando as variaveis angiograficas e ultra-sonograficas e a evolucao clinica aos 30 dias de pacientes portadores de lesoes em PS tratados com stent balao-expansivel MGuard® (n = 11) vs. stent auto-expansivel SESAME® (n = 14). RESULTADOS: Os pacientes tratados com stents MGuard® e SESAME® demonstraram perfis clinicos superponiveis (media de idade, 69 anos; sexo masculino, 72%; diabeticos, 28%; tratados na vigencia de sindrome coronaria aguda, 44%), idade dos enxertos venosos aortocoronarios equivalentes (9,7 ± 6,2 anos vs. 10,1 ± 3,2 anos; p = 0,80) e PS com o mesmo grau de acometimento aterosclerotico. O sucesso angiografico pos-procedimento foi alcancado em todos os casos, porem com tendencia a melhor expansao do stent no grupo MGuard® (87% vs. 68%; p = 0,08). No seguimento clinico de 30 dias, os pacientes tratados com stent SESAME® apresentaram maior frequencia de eventos cardiacos maiores (dois casos de infarto do miocardio nao-Q e um caso de revascularizacao do vaso-alvo), comparativamente a nenhum evento no grupo MGuard®. CONCLUSOES: Nessa analise retrospectiva de pequena serie de pacientes pre-selecionados de duas series first-in-human, o stent balao-expansivel MGuard® mostrou-se superior ao stent auto-expansivel SESAME® nos primeiros 30 dias de acompanhamento clinico.

Stents were introduced into clinical practice in the late 1980s. Subsequently, the Belgian Netherlands STENT and the Stent Restenosis Study trials established the “stent era” in coronary revascularization (1,2), despite an subacute thrombosis (SAT) rate of 3.7%, and more vascular bleeding complications with stents vs balloon angioplasty. Major advances in stent technologies have occurred in the past decades. Stent design has been altered to afford more flexibility, higher radial strength, lower profile, and minimal metallic coverage. Efforts are now directed at coating a stent with single or multiple bioactive antirestenosis agents, which is delivered uniformly to the underlying tissue, namely drug-eluting stents (DES). Recent clinical data (Table 1), which will be discussed in this chapter, have demonstrated the potential of these new stent technologies to become the predominant revascularization strategy in the near future. The list of promising DES technologies is long. Many of these devices were supported by sound basic science data, but only a few have proven clinical feasibility (Table 1). Based on the mechanism of action of the biological compound and its target in the restenotic process, DES were grouped as immunosuppressive, antiproliferative, anti-inflammatory, antithrombotic, and prohealing. Some agents, such as sirolimus, may affect multiple targets in the restenotic process but will be discussed under a single category.

C-reactive protein (CRP) is an inflammatory marker that predicts cardiac events in patients with coronary syndromes. However, data on the relationship between the CRP level and in-stent restenosis are contradictory. The objective of this study was to investigate the relationship between the basal CRP level and the neointimal hyperplasia volume measured by intracoronary ultrasound 4 months after implantation of a zotarolimus-eluting stent.The study included 40 consecutive patients who underwent zotarolimus-eluting stent implantation. Patients were divided into quartiles according to their preprocedural CRP level. Intracoronary ultrasound was performed after stent implantation and at 4 months, and the neointimal hyperplasia volume was determined using Simpson's rule. Correlation and linear regression analyses were used to evaluate the relationships between variables. Multivariate analysis was used to identify variables that were independently related to neointimal hyperplasia volume.The patients' mean age was 58 (8) years, 55% were male, and 40% had diabetes mellitus. There was no difference in baseline characteristics between the quartiles. The hyperplasia volumes were 4.8 (4.2) microl and 15.8 (10.0) microl in the first and fourth quartiles, respectively (P.001). There was a significant positive correlation between the CRP level and neointimal hyperplasia volume (r = 0.64, P=.0001). The CRP level, the postimplantation lumen volume, and the final deployment pressure were all independent predictors of neointimal hyperplasia.In this study, an independent correlation was observed between the CRP level before zotarolimus-eluting stent implantation and the neointimal hyperplasia volume at 4-month follow-up.

Aim Late-acquired incomplete stent apposition (ISA) has been documented after drug-eluting stent (DES) implantation; however, its clinical role remains controversial. We sought to investigate the incidence and long-term clinical consequences of late ISA after implantation of sirolimus- (SES) or paclitaxel-eluting stent (PES) in a non-selected population. Methods and results From our database, we analysed 195 consecutive patients who underwent DES placement (175 with SES and 20 with PES) into native artery lesions and had serial intravascular ultrasound studies (IVUS) performed at index procedure and after 6–8 months. They were clinically followed for 29 ± 15 months (median of 24.3 months, interquartile range 18.1–31.6 months). Late ISA was defined as separation of at least one stent strut from the vessel wall in a segment without a side-branch and where the immediate post-implantation IVUS revealed complete apposition of stent struts. We identified 10 patients (5.1%) with late ISA, three patients after PES, and seven patients after SES implantation. ISA was localized almost exclusively at body of the stents (nine out of 10 cases). Mean ISA volume and length were 44.5 ± 41.9 mm3 and 7.4 ± 11 mm, respectively. There was a marked increase in vessel volume from 416.0 ± 163.9 mm3 at baseline to 514.4 ± 247.9 mm3 at follow-up ( P = 0.001) with no significant change in plaque volume (232.4 ± 52.7 at baseline and 226.4 ± 22.3 mm3 at follow-up, P = 0.3) in patients who presented with late-acquired ISA. During the follow-up period, one patient with SES and one patient with PES who presented late-acquired ISA had late stent thrombosis and acute myocardial infarction. Conclusion Late-acquired ISA was observed in 5.1% of patients after DES implantation and is related to regional vessel positive remodelling. The relationship between late-acquired ISA and long-term adverse outcomes (e.g. stent thrombosis) requires further analysis.

OBJETIVO: Avaliar a ocorrência de variáveis detectoras de isquemia miocárdica, durante ou após o tratamento odontológico, sob anestesia com vasoconstritor (adrenalina). MÉTODOS: Foram incluídos 54 pacientes coronariopatas submetidos a exodontia sob anestesia local com ou sem vasoconstritor, divididos em dois grupos (sorteio por envelope): grupo I, composto por 27 que receberam anestésico com vasoconstritor; e grupo II, composto por 27 que receberam anestésico sem vasoconstritor. Todos os pacientes foram submetidos a monitoração eletrocardiográfica com Holter por 24 horas, a Doppler-ecocardiografia realizada antes e após intervenção odontológica, e a dosagem dos marcadores bioquímicos antes e 24 horas após a exodontia (creatina cinase fração MB [CK-MB] massa, CK-MB atividade e troponina T). A freqüência cardíaca e a pressão arterial nas fases pré-anestesia, pós-anestesia e pós-exodontia também foram aferidas. A Doppler-ecocardiografia teve como objetivo avaliar a contratilidade segmentar do ventrículo esquerdo e a eventual ocorrência de insuficiência mitral. Em todos os casos foi mantido o protocolo farmacológico habitual prescrito pelo cardiologista. RESULTADOS: Três pacientes do grupo I apresentaram depressão do segmento ST (1,0 mm) durante a aplicação da anestesia, dois outros pacientes do mesmo grupo tiveram elevação da CK-MB massa, e em nenhum caso foi verificada presença de isquemia avaliada pelos demais métodos. Não houve registro, neste estudo, de precordialgia, arritmias e ocorrência ou agravamento de hipocontratilidade segmentar do ventrículo esquerdo ou insuficiência mitral. CONCLUSÃO: A exodontia praticada sob uso de anestesia com adrenalina 1:100.000 não implica riscos isquêmicos adicionais quando realizada com boa técnica anestésica e manutenção do tratamento farmacológico prescrito pelo cardiologista. OBJECTIVE: To evaluate the occurrence of variables detecting myocardial ischemia during or after dental treatment under anesthesia with vasoconstrictor (epinephrine). METHODS: A total of 54 coronary patients undergoing dental extraction under local anesthesia with or without vasoconstrictor were included. They were divided into two groups (by drawing envelopes): group I (27 patients) using anesthetics with vasoconstrictor, and group II (27 cases) without vasoconstrictor. 24-hour Holter monitoring, Doppler-echocardiogram before and after dental intervention, and determination of biochemical markers (CK-MB mass, CK-MB activity, and troponin T) before and 24 hours after dental extraction were performed in all patients. Heart rate and blood pressure were also measured in the pre, post-anesthesia and post-dental extraction phases. Doppler echocardiography assessed left ventricular segmental contractility and the occasional occurrence of mitral regurgitation. The usual pharmaceutical treatment prescribed by the cardiologist was maintained in all cases. RESULTS: Three patients in group I presented ST-segment depression (1.0 mm) during administration of anesthesia; two other patients in group I had CK-MB mass elevation, and ischemia was not observed in any other case, as assessed by the other methods. No chest pain, arrhythmias, occurrence or worsening of left ventricular segmental hypocontractility or mitral regurgitation were observed in the study. CONCLUSION: Dental extraction performed under anesthesia with 1:100,000 epinephrine does not imply additional ischemic risks, as long as performed with good anesthetic technique and maintenance of the pharmacological treatment prescribed by the cardiologist.

INTRODUÇÃO: Pacientes multiarteriais tratados percutaneamente apresentam resultados semelhantes àqueles submetidos à cirurgia em relação à ocorrência de eventos cardíacos maiores, embora novos procedimentos de revascularização sejam mais freqüentes nos primeiros. OBJETIVO: Avaliar os resultados a longo prazo da revascularização percutânea com o implante de stents coronários versus a cirurgia no tratamento da doença multiarterial, verificando a incidência de morte, infarto do miocárdio (IAM), acidente vascular encefálico (AVE) e a realização de novas intervenções. MÉTODO: Estudo randomizado realizado no período de abril/1997 a junho/1998, no qual foram incluídos 66 pacientes multivasculares submetidos ao implante de stents não farmacológicos (33 P) e à cirurgia (33 P). RESULTADOS: Ao final de um período médio de acompanhamento clínico de 8 anos, constatamos que não ocorreram diferenças significativas na sobrevivência livre de eventos cardiovasculares maiores (morte, IAM e AVE), nos 2 grupos: stent - 74% x cirurgia - 85,1%; p=NS. Procedimentos adicionais de revascularização foram mais freqüentes no pacientes tratados com stents, comparativamente àqueles tratados pela cirurgia (respectivamente, 15 P - 45% x 5 P - 15%; p=0,01). Como conseqüência destes resultados, a sobrevivência livre de todos os eventos, inclusive nova revascularização, foi significativamente menor no grupo percutâneo versus o cirúrgico (49% x 80,5%; p=0,0082). CONCLUSÃO: A revascularização com o implante de stents não farmacológicos, no tratamento da doença multiarterial, oferece o mesmo grau de proteção contra eventos cardiovasculares maiores, quando comparada à cirurgia. Contudo, a sobrevivência livre de todos os eventos a longo prazo foi significativamente menor nos pacientes tratados percutaneamente, devido à necessidade mais freqüente de novos procedimentos de revascularização. BACKGROUND: Patients with multivessel disease treated percutaneously have similar outcomes when compared to those submitted to surgical procedures in terms of major cardiac events, although the former require new revascularization procedures more frequently. OBJECTIVE: To assess long-term clinical outcomes after coronary artery bypass graft (CABG) for the treatment of multivessel disease versus surgical procedures to treat multivessel disease determining death, AMI, and stroke incidence rates, as well as new interventions. METHODS: A randomized study carried out between April, 1997 and June, 1998 included 66 patients submitted to non-drug eluting stenting (33P) and surgery (33P). RESULTS: Clinical follow-up results after 8 years have shown no significant difference between the two groups in terms of survival free of MACE events (death, stroke or AMI): STENTING: 74% X CABG: 85.1%; p= not significant). Additional revascularizations were more frequent in the stenting group as compared to the surgery group (15 P - 45% x 5 P - 15%, respectively, p=0.01). Consequently, survival rates without MACE and repeated revascularization was significantly lower in patients assigned to stenting when compared to those assigned to CABG (49% x 80.5%, respectively, p=0.0082). CONCLUSION: Percutaneous revascularization with non-drug eluting stenting for the treatment of multivessel disease offers the same degree of protection against MACE (death, stroke and AMI) as compared to CABG. However, stenting is associated with a greater need of repeated revascularization and lower total event-free survival rates.

OBJETIVO: Identificar os perfis clínico/angiográfico e relacionados ao procedimento de pacientes com angina instável atendidos em um hospital terciário e tratados por meio de intervenções coronarianas percutâneas. MÉTODOS: Estudo de uma casuística consecutiva de 1.413 pacientes, selecionados a partir de um banco de dados informatizado e revascularizados percutaneamente no triênio 2002-2004. Não houve critérios de inclusão/exclusão. RESULTADOS: Hipertensão arterial sistêmica (74%) e hipercolesterolemia (65%) foram os fatores de risco clássicos para doença coronariana mais observados. Antecedentes de infarto do miocárdio e cirurgia de revascularização miocárdica foram respectivamente observados em 28% e 24% dos casos. Os subgrupos mais comumente tratados foram o IIB (48%) e IIIB (28%). O clopidogrel foi prescrito a 51% dos pacientes, enquanto os inibidores IIb IIIa foram utilizados em 7%. Doença coronariana multiarterial na cinecoronariografia diagnóstica ocorreu em 42% dos casos. Lesões-alvo tipo B2 ou C foram tratadas em 64%, das quais 94% situavam-se em vasos naturais. Lesões reestenóticas foram dilatadas em 5% dos pacientes. Todas as intervenções foram realizadas utilizando os stents coronarianos, a maioria dos quais (67%) do tipo convencional. CONCLUSÕES: 1) os subgrupos IIB e IIIB foram os mais comumente tratados (76%); 2) o clopidogrel foi o antitrombótico mais prescrito (51%); 3) a coronariopatia multiarterial foi observada em 42% dos casos, com predomínio de lesões-alvo complexas e situadas em vasos naturais; 4) a técnica de dilatação predominante foi o implante dos stents coronarianos. OBJECTIVE: To identify clinical and angiographic profiles of patients with unstable angina seen at a tertiary hospital and treated with percutaneous coronary intervention (PCI). METHODS: Study of a consecutive series of 1413 patients, selected from a computerized database, who underwent percutaneous revascularization in the three-year period of 2002-2004. There were no inclusion/exclusion criteria. RESULTS: Systemic arterial hypertension (74%) and hypercholesterolemia (65%) were the classical risk factors for coronary disease most frequently observed. Coronary artery bypass grafting and history of myocardial infarction were found in 24% and 28% of the cases, respectively. The subgroups most commonly treated were the IIB (48%) and IIIB (28%). Clopidogrel was prescribed for 51% of the patients and glycoprotein IIb/IIIa inhibitors, for 7%. Multivessel disease evidenced by coronary angiography was detected in 42% of the cases. Type B2 or C lesions were treated in 64%, 94% of which in native vessels. Restenotic lesions were dilated in 5% of the patients. All interventions were performed using coronary stents, the majority of which (67%) were standard bare-metal stents. CONCLUSIONS: 1) Subgroups IIB and IIIB were the most frequently treated (76%); 2) Clopidogrel was the most prescribed antithrombotic agent (51%); 3) Multivessel coronary artery disease was found in 42% of the cases, most of which were complex target lesions located in native vessels; 4) Coronary stent implantation was the chief dilation technique used.

To evaluate the occurrence of variables detecting myocardial ischemia during or after dental treatment under anesthesia with vasoconstrictor (epinephrine).A total of 54 coronary patients undergoing dental extraction under local anesthesia with or without vasoconstrictor were included. They were divided into two groups (by drawing envelopes): group I (27 patients) using anesthetics with vasoconstrictor, and group II (27 cases) without vasoconstrictor. 24-hour Holter monitoring, Doppler-echocardiogram before and after dental intervention, and determination of biochemical markers (CK-MB mass, CK-MB activity, and troponin T) before and 24 hours after dental extraction were performed in all patients. Heart rate and blood pressure were also measured in the pre, post-anesthesia and post-dental extraction phases. Doppler echocardiography assessed left ventricular segmental contractility and the occasional occurrence of mitral regurgitation. The usual pharmaceutical treatment prescribed by the cardiologist was maintained in all cases.Three patients in group I presented ST-segment depression (1.0 mm) during administration of anesthesia; two other patients in group I had CK-MB mass elevation, and ischemia was not observed in any other case, as assessed by the other methods. No chest pain, arrhythmias, occurrence or worsening of left ventricular segmental hypocontractility or mitral regurgitation were observed in the study.Dental extraction performed under anesthesia with 1:100,000 epinephrine does not imply additional ischemic risks, as long as performed with good anesthetic technique and maintenance of the pharmacological treatment prescribed by the cardiologist.

OBJETIVO: Avaliar os resultados da tomografia computadorizada por múltiplos detectores na avaliação dos resultados tardios de pacientes submetidos ao implante de endopróteses com sirolimus. MÉTODOS: Selecionamos 30 pacientes, previamente submetidos ao implante de stents com sirolimus com sucesso e com mais de seis meses de evolução. Todos foram submetidos à angiografia invasiva e ao ultra-som intravascular após a angiotomografia, feita com a injeção de 1,5 ml/kg de peso de meio de contraste iodado. RESULTADOS: A média dos diâmetros proximais de referência foi 3,01 ± 0,31 mm pela tomografia e 3,14 ± 0,31 mm pela angiografia (p = 0,04). Ao eliminarmos a artéria circunflexa da análise, a discrepância entre os dois exames deixou de ser significante -(tomografia= 3,01 ± 0,32 mm, angiografia= 3,10 ± 0,30 mm, p = 0,65). A média dos diâmetros distais de referência foi 2,86 ± 0,30 mm pela tomografia e 2,92 ± 0,32 pela angiografia (p = 0,25). A média do calibre mínimo no interior da endoprótese foi 2,85 ± 0,25 mm pela tomografia e 2,85 ± 0,29 mm angiografia (p = 0,27). A área de secção transversal mínima intra-stent foi 7,19 ± 1,47 mm² pela tomografia e 6,90 ± 1,52 mm² pelo ultra-som intracoronariano (p = 0,36), mas a correlação entre estas medidas era fraca (r= 0,33). CONCLUSÃO: A tomografia possibilita a avaliação qualitativa das endopróteses, a estimativa correta do diâmetro de referência proximal e distal dos vasos-alvo, além do calibre mínimo intra-stent. Sua correlação com as medidas feitas pelo ultra-som intracoronário, porém é menos intensa.

To correlate myocardial perfusion scintigraphy (MPS) with Tc-99m-MIBI and adenosine infusion using quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS).Seventy patients with coronary artery disease (CAD) referred for myocardial perfusion scintigraphy (MPS) with MIBI and adenosine were studied. Clinical, electrocardiographic (ECG), and scintigraphic findings were correlated with variables of visual and quantitative angiographic analysis, as well as to those of IVUS.The mean age of patients was 60.6 years, and 39 were male. Coronary angiography showed percentage of diameter stenosis (% DS) of 49.94% in 105 arteries, 83 of which were re-evaluated by QCA (79%), mean of 44.20%, p0.05. ST-segment depression during adenosine infusion was associated with higher degrees of % DS (55.0% vs. 47.8%), p0.05). Scintigraphic ischemia was correlated with greater cross-sectional area of lumen obstruction by IVUS (% CSA). Clinical, ECG, and IVUS findings were considered together and expressed as global ischemic versus non-ischemic responses. Ischemia was associated with lower values of minimal lumen diameter (MLD) and minimal lumen area (MLA) determined by QCA and IVUS.Tc-99m-MIBI and adenosine myocardial SPECT is correlated with % CSA on IVUS, perfusion images considered. Global results assessment showed association between lumen diameter and area at obstructed sites as determined by QCA and IVUS.

OBJETIVO: Estabelecer a correlação da cintilografia de perfusão do miocárdio (CPM) com Tecnécio 99m-MIBI (MIBI) e injeção de adenosina, empregando a angiografia coronária quantitativa (ACQ) e o ultra-som intracoronário (UIC) como comparação. MÉTODOS: Estudo de 70 pacientes com doença arterial coronária (DAC), encaminhados à CPM com MIBI e adenosina. As manifestações clínicas, do eletrocardiograma (ECG) e os resultados das imagens foram correlacionadas às variáveis da análise visual e quantitativa da angiografia, bem como ao UIC. RESULTADOS: A média de idades foi de 60,6 anos, com 39 pacientes do sexo masculino. A angiografia coronária evidenciou estenose do diâmetro da luz (E%) de 49,94% em 105 artérias, com reavaliação à ACQ em 83 artérias (79%) e média de 44,20%, p

To identify clinical and angiographic profiles of patients with unstable angina seen at a tertiary hospital and treated with percutaneous coronary intervention (PCI).Study of a consecutive series of 1413 patients, selected from a computerized database, who underwent percutaneous revascularization in the three-year period of 2002-2004. There were no inclusion/exclusion criteria.Systemic arterial hypertension (74%) and hypercholesterolemia (65%) were the classical risk factors for coronary disease most frequently observed. Coronary artery bypass grafting and history of myocardial infarction were found in 24% and 28% of the cases, respectively. The subgroups most commonly treated were the IIB (48%) and IIIB (28%). Clopidogrel was prescribed for 51% of the patients and glycoprotein IIb/IIIa inhibitors, for 7%. Multivessel disease evidenced by coronary angiography was detected in 42% of the cases. Type B2 or C lesions were treated in 64%, 94% of which in native vessels. Restenotic lesions were dilated in 5% of the patients. All interventions were performed using coronary stents, the majority of which (67%) were standard bare-metal stents.1) Subgroups IIB and IIIB were the most frequently treated (76%); 2) Clopidogrel was the most prescribed antithrombotic agent (51%); 3) Multivessel coronary artery disease was found in 42% of the cases, most of which were complex target lesions located in native vessels; 4) Coronary stent implantation was the chief dilation technique used.

The purpose of the study was to examine the safety and efficacy of two different formulations of mycophenolic acid (MPA)-eluting Duraflex stents on coronary de novo lesions. Recent data indicate that local delivery of MPA in the porcine overstretch coronary model significantly reduces neointimal hyperplasia (NIH). Patients were divided into three consecutive groups. The first (n=50) and second (n=55) groups received moderate- and slow-release MPA-eluting Duraflex stent, respectively. The last group (n=50) received the bare metal Duraflex stent. Clinical, angiographic, and intravascular ultrasound analysis were performed at 6-month follow-up. All stents were successfully deployed and patients were discharged home without clinical events. Compared to controls, 6-month in-lesion and in-stent minimum luminal diameter as well as late lumen loss were not significantly different in the moderate- and slow-release treatment groups. At follow-up, percentage obstruction and NIH volume were also similar between the three groups. At 30 days and 6 and 12 months, there were no differences noted between the three groups with respect to major adverse cardiac events as well as the individual rates of mortality, myocardial infarction, or repeat revascularization. There were no cases of subacute or late thrombosis. In this feasibility trial, the MPA-eluting Duraflex stents in either slow- or moderate-release formulations were well tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. Further testing with different drug dosing or delivery rate might improve these results.

This pilot study evaluated the safety and efficacy of an intensified oral sirolimus regimen (15-mg loading dose 24 hr before PCI, followed by a daily dose of 5 mg for 4 weeks) in 15 patients subjected to elective bare metal coronary stent implantation for de novo lesions. Mean patient age was 59 ± 9; 73% were male, and 13% were diabetic patients. The reference diameter was 3.04 ± 0.38 mm, and the lesion length was 14 ± 2 mm. Angiographic and volumetric intravascular ultrasound (IVUS) analyses were performed in all patients at 6.0 ± 0.2 months. Two patients (13%) met the definition of in-segment binary restenosis; in-stent and in-segment angiographic late loss was 0.61 ± 0.31 mm and 0.67 ± 0.45 mm, respectively, and the percent neointimal volume was 28.5 ± 15.8%. At adjacent reference segments, there was neither significant plaque increase nor constrictive vascular remodeling. At 24-month follow-up no deaths, myocardial infarctions, or target lesion revascularizations were detected. Mean sirolimus blood level was 13 ± 7 ng/ml. No correlations were found between drug levels and late loss (r = 0.15, P = 0.59) or IVUS percent neointimal volume (r = 0.23, P = 0.47). Side effects were frequent (80%), leading to dose reductions in four and drug discontinuation in one patient. The results of this pilot study suggest that an intensified 5-mg oral sirolimus regimen resulted in no relevant improvements in the angiographic and IVUS parameters of restenosis after stent implantation in de novo lesions when compared with historic controls. Considering the efficacy/safety balance, our results do not encourage further trials evaluating the current protocol for the prevention of in-stent restenosis. © 2005 Wiley-Liss, Inc.

To evaluate the safety and efficacy of surgical treatment approach vs. conservative approach in patients with ambiguous lesions in the left main coronary artery (LMCA), based on intracoronary ultrasound (ICUS) findings.Sixty-six consecutive patients with angiographically ambiguous lesions were included and submitted to ICUS assessment. They were divided in two groups, according to the ICUS findings. Group I was maintained under clinical treatment [minimal lumen area (MLA)6.0 mm(2) and/or minimal lumen diameter (MLD)2.5 mm] and Group II was submitted to revascularization (MLA6.0 mm(2) and/or MLD2.5 mm). The occurrence of major cardiac events (death, acute myocardial infarction and/or revascularization of the target lesion) was assessed during follow-up.Forty-one (62%) patients were allocated in Group I and 25 (38%) in Group II. Mean follow-up was 42.1 months. The coronary angiography did not differentiate the two groups regarding lesion severity (MLD 1.98 mm in Group I vs. 1.72 mm in Group II; p = 0.75) in opposition to ICUS (MLD 3.41 mm in Group I vs. 2.01 mm in Group II; p0.001). There was no death or myocardial infarction in Group I. The survival rate free of major cardiac events was 95% in Group I vs. 87.5% in Group II (p=ns).Treatment decision-making of patients with ambiguous lesions in the LMCA guided by ICUS findings showed to be safe and effective.

To the Editor: Mehilli et al1 reported that abciximab did not reduce death or myocardial infarction after percutaneous intervention in diabetics pretreated with a 600-mg loading dose of clopidogrel, but that it reduced restenosis in the subgroup treated with bare-metal stents (BMS). We previously reported that abciximab was not associated with a reduction of in-stent intimal hyperplasia measured by intravascular ultrasound in patients with diabetes treated with BMS. In-stent volume obstruction, a surrogate for in-stent restenosis, did not differ between patients with diabetes treated with or without abciximab.2 In an attempt to reconcile these data, we found that some aspects of the ISAR-SWEET study need to be clarified. First, the analysis of restenosis was done on a per-lesion basis rather than on a per-patient basis. The statistical tests used assumed that lesions within the same patient are independent for restenosis. We learned from Kastrati et al,3 however, that there is an interlesion dependence of restenosis in patients who undergo multilesion intervention (the probability of restenosis for a lesion being higher when a companion lesion has also developed restenosis). Hence, it follows that the correlation among lesions within patients had to be considered and an alternative statistical model that takes into account the correlations applied (eg, linear mixed-effect models). Second, the angiographic results were presented for the groups …

Background This report describes two original echocardiographic approaches to measure right ventricular (RV) mass (RVM). Methods In the bullet formula (5/24 π D1 D2 L), where D1 and D2 are short axes and L the log axis, the RVM is obtained by subtracting the cavity volume from the RV total volume and subsequently multiplying the difference by myocardium density. The second method uses 3 endocardium segments measured at: (1) short axis plane of the aortic valve and left atrium (b1); (2) short axis plane at the midpoint between the tricuspid valve annulus and the apex (b2); and (3) 4-chamber view (h). Those segment lengths are applying in the formula A=[(b1 + b2)/2] × h. The result is multiplied by the wall thickness and by myocardium density. Results Both formulas were primarily tested in 30 mongrel dogs and have shown good correlation with the true mass ( r = 0.869 with the segments formula and r = 0.819 with the bullet formula). The same method was used in 20 human patients before heart transplant with similar results ( r = 0.810 with the segments formula and r = 0.836 with the bullet formula). Conclusions The RVM can be satisfactorily estimated by 2-dimensional echocardiography. The linear regression between the calculated mass (using the smoothest and thinner myocardium thickness) and the actual mass may provide the correction factor for the RVM calculation. Two echocardiographic methods were used to measure right ventricular mass. One of them used a bullet formula variant (5/24 π D1 D2 L). The second method used 3 endocardium segments measured in 3 2-dimensional echocardiographic planes (short axis of aortic valve and left ventricle, and 4-chamber view), and applied in the formula A=[(b1 + b2)/2] × h. Both formulas have shown good correlation with the true mass in 30 mongrel dogs ( r = 0.869 with the segments formula and r = 0.819 with the bullet formula) and in 20 human patients before heart transplant ( r = 0.810 and r = 0.836, respectively).

Background— Despite the proven superiority of sirolimus-eluting stents (SESs) compared with bare stents in the first year after implantation, long-term outcomes of patients treated with these novel devices remain unknown. Our goal was to evaluate the clinical, angiographic, and intravascular ultrasound (IVUS) outcomes of patients treated with SESs 4 years after implantation. Methods and Results— The study included 30 patients treated with sirolimus-eluting Bx Velocity stenting (slow release [SR; n=15] and fast release [FR; n=15]). Twenty-six patients underwent 4-year angiographic and IVUS follow-up and had matched assessments at all time points (index and 4-, 12-, 24-, and 48-month follow-up). One death occurred during the study period in a patient with a patent SES. There were no target-vessel revascularizations or thromboses between 2- and 4-year follow-up examinations. There was no stent thrombosis, target-lesion revascularization, death, or myocardial infarction in the SR group up to 4 years. Cumulative event-free survival rate was 87% for the total population (80% in the FR group and 93% in the SR group). In-stent late loss was slightly greater in the FR group (0.41±0.49 mm) than the SR group (0.09±0.23) after 4 years. One patient in the FR group had a 52% in-stent restenosis lesion. Percent neointimal hyperplasia volume, as detected by IVUS, remained minimal after 4 years (FR=9.1% and SR=5.7%). Conclusions— This study confirms the longevity of the optimal outcomes observed in patients treated with sirolimus-eluting Bx Velocity stents 4 years after implantation. In-stent lumen dimensions remained essentially unchanged at 4-year follow-up, particularly in the population treated with the currently available SES (SR formulation).