Comparison of a vascular closure device versus the radial approach to reduce access site complications in non-ST-segment elevation acute coronary syndrome patients: The angio-seal versus the radial approach in acute coronary syndrome trial

OBJECTIVES:To compare the radial versus femoral approach using Angio-Seal for the incidence of access site complications among non-ST-segment elevation acute coronary syndrome patients undergoing invasive strategy. BACKGROUND: Arterial access is a major site of complications after invasive coronary procedures. Vascular closure devices provide more comfort to patients decreasing time to hemostasis and need for bed rest. However, the inconsistency of data proving their safety limits their routine adoption as a strategy to prevent vascular complications. METHODS: Single-center non-inferiority trial where 240 patients were randomized to radial or femoral access using Angio-Seal. The primary objective was the occurrence of complications at the arterial puncture site until 30 days after the procedure...

Seguimento de 12 meses de pacientes complexos tratados com stentsfarmacológicos liberadores de everolimus XIENCE V® na prática diária – resultados do registro brasileiro BRAVO / Twelve-month follow-up of complex patients treated with the Xience V™ everolimus drug-eluting stents in daily practice – results of the BRAVO Brazilian Registry

O stent liberador de everolimus XIENCE V® é um stent farmacológico de nova geração que incorpora uma plataforma de cromo-cobalto de baixo perfil (81 m) e um polímero de elevada biocompatibilidade (fluoropolímero), o qual carreia e controla a liberação do fármaco everolimus. Estudos recentes demonstram segurança e eficácia sustentadas do dispositivo XIENCE V® no tratamento de populações da prática clínica. Nosso objetivo foi reportar resultados clínicos de 12 meses do protocolo brasileiro BRAVO. Métodos: O registro BRAVO foi um estudo prospectivo, não randomizado, de braço único, multicêntrico (25centros), que avaliou os resultados clínicos tardios de 535 pacientes minimamente selecionados, tratados com o stent farmacológico XIENCE V®.Resultados: Cerca de 40% dos pacientes tinham diabetes, 25% infarto agudo do miocárdio prévio e 42% apresentaram-se com síndrome coronária aguda. A maioria das lesões (69%) era de elevada complexidade(ACC/AHA tipo B2/C). As médias da extensão e do diâmetro nominais dos stents foram, respectivamente, 19,9 ± 5,3 mm e 3,0 ± 0,4 mm. Os sucessos angiográfico e de procedimento foram de 99,7 e 98%, respectivamente. Aos 12 meses, a taxa cumulativa de eventos cardíacos adversos maiores, disponível em 100% dos pacientes, foi de 5,6% (morte cardíaca: 1,3%; infarto agudo do miocárdio: 3,0%; revascularização da lesão-alvo: 2,2%). Já a trombose de stent ocorreu em cinco pacientes (0,9%), sendo reportada apenas uma ocorrência entre 6 e 12 meses. Conclusões: O stent farmacológico XIENCE V® demonstrou segurança e eficácia sustentadas ao final de 12meses no tratamento de lesões coronárias complexas em pacientes da prática diária...

The Xience VTM everolimus-eluting stents is a new generation drug-eluting stent (DES)that incorporates a low profile cobalt-chromium platform (81 m) and a highly biocompatible polymer(fluoropolymer), which carries and controls the release of everolimus. Recent studies have demonstrated sustained safety and efficacy of the Xience VTM in the treatment of real-world populations. Our aim was to report the clinical results of 12 months of the BRAVO Brazilian protocol. Methods: The BRAVO Registry was a prospective, non-randomized, single-arm, multicenter (25 centers) study that evaluated the late clinical results of 535 minimally selected patients treated with the drug eluting stent Xience VTM in Brazilian daily practice. Results: Overall, 40% of patients had diabetes, 25% prior myocardial infarction, and 42% presented with acute coronary artery syndrome. The majority of lesions (69%) was highly complex (ACC/AHA type B2 or C).The mean length and the nominal stent diameter were 19.9 ± 5.3 mm and 3.0 ± 0.4 mm, respectively.The angiographic and procedural successes were 99.7 and 98%, respectively. At 12 months, the cumulative rate of major adverse cardiac events, available in 100% of patients, was 5.6% (cardiac death: 1.3%; acute myocardial infarction: 3.0%; revascularization of the target lesion: 2.2%). Stent thrombosis occurred in 5 patients (0,9%), and only 1 case was reported between 6 and 12 months. Conclusions: The drug-eluting stent Xience V™ demonstrated sustained safety and efficacy up to 12 months in the treatment of complex coronary lesions in patients from daily practice...

Desfechos clínicos aos 30 dias do registro brasileiro das síndromes coronárias agudas (ACCEPT) / Clinical outcomes at 30 days in the brazilian registry of acute coronary syndromes (ACCEPT)

FUNDAMENTO: São escassos os registros documentando a prática clínica brasileira na vigência de uma síndrome coronária aguda. OBJETIVOS: Descrição da demografia, ocorrência de desfechos graves e análise comparativa dentre aqueles que efetivaram ou não uma estratégia invasiva (cinecoronariografia e revascularização miocárdica) em um registro brasileiro multicêntrico de portadores de uma síndrome coronária aguda. MÉTODOS: O registro ACCEPT/SBC coletou prospectivamente, em 47 centros hospitalares brasileiros, pacientes na vigência de uma síndrome coronária aguda. Apresentamos a ocorrência de desfechos clínicos graves, de modo integral, e de acordo com a submissão ou não a um procedimento de revascularização do miocárdio ao final dos primeiros 30 dias de seguimento. RESULTADOS: De agosto de 2010 até dezembro de 2011, 2.485 pacientes foram incluídos neste registro. Destes, 31,6% eram portadores de angina instável e 34,9% e 33,4%, com síndrome sem e com supradesnível do segmento ST. Aos 30 dias, a submissão a procedimento de revascularização do miocárdio foi progressivamente maior de acordo com a gravidade da apresentação clínica (38,7% versus 53,6% versus 77,7%; p < 0,001). A ocorrência de mortalidade cardíaca, dentre aqueles submetidos ou não à revascularização miocárdica, foi de 1,0% versus 2,3% (p = 0,268), 1,9% versus 4,2% (p = 0,070) e 2,0% versus 8,1% (p < 0,001), angina instável, síndrome sem e com supradesnível do segmento ST, respectivamente. CONCLUSÕES: A prescrição de revascularização do miocárdio foi progressivamente mais frequente de acordo com a gravidade da apresentação clínica; naqueles atendidos na vigência de síndrome coronária sem e com supradesnível do segmento ST, promoveu tendência e redução significativa da mortalidade, aos 30 dias, respectivamente.

BACKGROUND: There are few registries documenting clinical practice in Brazilian patients with acute coronary syndrome. OBJECTIVES: Demography description, occurrence of major clinical adverse events and comparative analysis in patients submitted or not to an invasive strategy (coronary angiography and myocardial revascularization) in a Brazilian multicenter registry of acute coronary syndrome. METHODS: The ACCEPT/SBC registry prospectively collected data on acute coronary syndrome patients from 47 Brazilian hospitals. The current analysis reports the occurrence of major clinical outcomes and according to the performance or not of a procedure for myocardial revascularization at the end of 30 day follow-up. RESULTS: Between August 2010 and December 2011, 2.485 patients were enrolled in this registry. Of these, 31.6% had unstable angina, 34.9% and 33.4% had acute coronary syndrome without and with ST-segment elevation. At 30 days, the performance of a myocardial revascularization procedure was progressively higher according to the severity of clinical presentation (38.7% vs. 53.6% vs. 77.7%, p < 0.001). Cardiac mortality among those submitted or not to myocardial revascularization procedure was 1.0% vs. 2.3% (p = 0.268), 1.9% vs. 4.2% (p = 0.070) and 2.0% vs. 8.1% (p < 0.001), in those with unstable angina, acute coronary syndrome without and with ST-segment elevation, respectively. CONCLUSIONS: The prescription of a myocardial revascularization procedure was progressively more frequent according to the severity of clinical presentation; for those treated during acute coronary syndrome without and with ST-segment elevation, there was a trend and significant decrease in mortality rate at 30 day of follow-up, respectively.

Correlation between quantitative angiographic and intravascular ultrasound parameters in patients treated with sirolimus analogous-eluting stents / Correlation between quantitative angiographic and intravascular ultrasound parameters in patients treated with sirolimus analogous-eluting stents

Abstract Despite the undeniable contribution of intravascular ultrasound (IVUS) and quantitative coronary

angiography (QCA) to assess drug-eluting stent (DES) effectiveness, the way these image modalities correlate to each other and to target-lesion revascularization

(TLR) after PCI, is yet to be established. Thus we sought to evaluate whether there is an acceptable correlation between QCA and IVUS after DES implantation. We analyzed 204 pts treated with

DES: Zotarolimus- (126), Sirolimus- (57), and Biolimus (31) with baseline and follow-upQCA and IVUS. The correlation between QCA lumen loss (LL) and intimal hyperplasia (IH) volume obstruction by IVUS

was assessed by multiple regression analysis. Two QCA parameters (in-segment diameter stenosis and insegment

LL) and one IVUS variable (in-stent volume of IH) were evaluated as quantitative surrogates of 6 month TLR. The receiver operating characteristic method with c-statistics was used to assess the

ability of each surrogate endpoint to predict TLR. QCA LL correlated positively with IVUS IH volume of obstruction (r = 0.69; CI95% 0.61–0.75: P/0.0001), independent of DES type. The 2 QCA

parameters were superior to the IVUS parameter as surrogates for TLR. Of note, QCA LL (c = 0.99) correlated best with TLR, even better than percent DS. In the DES era there is a good correlation between

QCA measured LL and IVUS IH volume and therefore can be used as a surrogate of DES efficacy.

Impacto dos stents famacológicos no tratamento percutâneo de lesões coronárias em bifurcação: resultados clínicos tardios de um estudo comparativo incluindo pacientes do "mundo-real" / The impact of drug-eluting stents in the percutaneous treatment of bifurcation coronary lesions: late clinical outcomes of a comparative study including

Fundamentos: Historicamente, as intervenções coronárias percutâneas (ICP) em lesões de bifurcação associam-se com elevadas taxas de complicações, principalmente em decorrência dos resultados subótimos no ramo lateral (RL) e da necessidade de revascularização da lesão-alvo (RLA) durante seguimento tardio. Avaliamos o impacto dos stents farmacológicos (SF) na evolução clínica tardia de pacientes não-selecionados provenientes da prática clínica diária com lesão envolvendo bifurcação. Método: A partir de maio de 2002, 195 pacientes com lesão de bifurcação foram consecutivamente tratados em dois centros clínicos (grupo SF = 89 pacientes; grupo stent não-farmacológico [SNF] = 106), e o seguimento clínico foi completo até dois anos. Resultados: Os dois grupos apresentavam perfis clínicos semelhantes, incluindo média das idades de 63 anos, e 25% de diabetes melito. A maioria das lesões tinha comprometimento significativo dos dois ramos (78% vs. 76%; p = 0,82), a estratégia de stent provisional RL foi utilizada na maioria dos casos (75% vs. 89% de SNF; p = 0,45), e o sucesso angiográfico no RL (fluxo TIMI 3, estenose residual < 50%, sem dissecção) 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 conseqüente maior sobrevida livre de eventos cardíacos adversos maiores (ECAM) (93,3% vs. 77,4%; p = 0,003). A trombose de stent ocorreu em 2 pacientes em cada grupo...

Background: Historically, percutaneous coronary interventions (PCI) in bifurcation lesions are associated with high rates of complications, especially due to suboptimal results in the lateral branch (LB) and the need for target lesion revascularization (TLR) during long-term follow-up. We assess the impact of drug-eluting stents in the late clinical follow-up of non-selected patients with bifurcation lesions coming from the daily clinical practice. Methods: Since May, 2002, 195 patients with bifurcation lesions were treated consecutively at two clinical centers [drugeluting stent (DES) group = 89; non drug-eluting stent (NDES) group = 106] and followed up for two years. Results: The two groups presented similar clinical profiles including mean age of 63 years and 25% with diabetes mellitus. The majority of lesions had significant involvement of the two branches (78% vs. 76%; p = 0.82), the provisional LB stent strategy was used in the majority of cases (75% DES vs. 89% NDES; p = 0.45), and the angiographic success in the lateral branch (TIMI 3 flow, residual stenosis < 50% without dissection) was achieved in 80% vs. 78% (p = 0.56) in the DES and NDES groups, respectively. After 24 months of follow-up, the DES group showed a higher survival free of TLR (97.8% vs. 82.1%; p < 0.0001), resulting in higher survival free of major adverse cardiac events (MACE) (93.3% vs. 77.4%; p = 0.003). Stent thrombosis occurred in 2 patients in each group...

Influência dos sintomas pré-procedimentos na evolução hospitalar e tardia das angioplastias carotídeas com implante de stent e sistemas de proteção cerebral / Influence of symptoms pre-procedure in hospital and late evolution of carotid angioplasty with stent implantation and cerebral protection systems

Introdução: A doença carotídea aterosclerótica (DCA) é responsável por 40 por cento dos acidentes vasculares cerebrais (AVC). Apesar de a intervenção carotídea percutânea (ICP) ser uma alternativa à endarterectomia, ainha 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. Métodos: Foram realizadas 262 ICP em 230 pacientes consecutivos, 61 (26,5 por cento) PAS versus 169 (73,5 por cento) PS. A angioplastia 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 por cento diabéticos. Obtivemos sucesso primário em 100 por cento 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 maior ou menos 7,6 por cento vs. 74,9 mais ou menos 12,5 por cento; p menor 0,01), mas o grupo PS apresentou lesões mais longas (18,3 mais ou menos 5,7 por cento vs. 21,7 mais ou menos 7,4 por cento; p menor 0,01). Aos 30 dias não houve diferença na incidência de AVC maior...

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.

Trombose de stent farmacológico no "mundo-real": análise crítica do registro DESIRE (Drug-Eluting Stent in the Real World) / Stent thrombosis after drug-eluting stenting in the \"real world\": critical analysis from DESIRE (Drug-Eluting Stent in the Real World) register

Fundamentos: Reportamos a incidência e os preditores de trombose de stent numa grande coorte de pacientes complexos tratados com stents farmacológicos (SF) no "mundo real", Métodos: Entre maio de 2002 e janeiro de 2008, 2.365 pacientes não selecionados com maior ou menor lesão coronária com estenose maior ou menor 50 por cento tratados com ST. O seguimento clínico até cinco anos (média 2,2 mais ou menos 1,5 anos) foi completado em 98,3 por cento. Resultados: Entre os pacientes avaliados 29 por cento tinham diabetes, 60 por cento eram portadores de doença multiarterial e 40 por cento apresentavam síndrome coronária aguda (15 por cento, infarto agudo do miocárdio [IAM]). A artéria descendente anterior foi o vaso-alvo mais frequentemente tratado (35,8 por cento) e 67 por cento das lesões eram de alta complexidade (tipo B2/C). No total, 3.634 SF foram implantados e 40 por cento dos pacientes receberam múltiplos stents. A trombose de stent (classificação Academic Research Consortium) incidiu em 1,6 por cento (n igual 38), 60,5 por cento com confirmação angiográfica...

Background: We report the incidence of stent thrombosis (ST) predictors in a large cohort of complex patients treated with drug eluting stents (DES) in the real world. Methods: From May 2002 until January 2008, 2,365 non-selected patients with ≥ 1 coronary lesion with stenosis of ≥ 50% were treated with DES. The clinical follow-up up to five years (mean time 2.2 ± 1.5 years) was completed in 98.3%. Results: Twenty nine percent of patients had diabetes and 60% multi-vessel disease, 40% presented acute coronary syndrome (15%, acute myocardial infarction [AMI]). The anterior descending artery was the target vessel most frequently treated (35.8%), and 67% were complex lesions (Type B2/C). In all, 3,634 DES were implanted and 40% received multiple stents. Stent thrombosis (classification ofthe Academic Research Consortium) occurred in 1.6% (n = 38), 60.5% with angiographic confirmation, 42% occurred between 1 and 12 months and 47% of the events had a fatal outcome. The independent predictors of ST were: current smoking [relative risk (RR) 2.59; 95% confidence interval (CI) 1.18-5.67; p = 0.018], AMI intervention (RR 3.50; 95% CI 1.31-9.40; p = 0.013), moderate to severe calcification (RR 2.38; 95% CI 1.34-4.23; p = 0.003), excentric lesion (RR 1.86; 95% CI 1.03-3.34; p = 0.039), > 1 DES implanted per myocardial territory (RR 1.81; 95% CI 1.09-3.02; p = 0.023), post-dilatation (RR 0.50; 95% CI 0.29-0.90; p = 0.020) and intra-stent residual stenosis [RR 1.04 (per % unit increase); 95% CI 1.01-1.06; p = 0.003]. Conclusions: In this real world prospective registry, the cumulative incidence of stent thrombosis up to 5 year follow-up was...

Análise volumétrica tardia após implante de stents eluidores de sirolimus versus biolimus A9 / Late volumetric analysis after implantation of sirolimus versus biolimus A9-eluting stents

Os stents eluidores de sirolimus (SES) reduaem significativamente a incidência de reestenose e de eventos cardíacos maiores em comparação a stents convencionais. O sirolimus A9 (BA9), um análogo do sirolimus, demosntrou eficácia e segurança simulares no estudo randomizado e controlado STEALTH I. O objetivo deste estudo é comparar a eficácia do stent eluidor de BA9 com os SES, assim como seu desempenho em relação ao respectivos grupos controle, utilizando a análise volumétrica pelo ultra-som intracoronário (3D-USIC). Método: No total, 45 pacientes foram randomizados 2:1 para o grupo submetido a implante de stents eluidores de BA9(n igual 30) ou para o grupo conrole (n igual 15). Os resultados de angiografia coronária quantitativa e 3D-USIC foram comparados a uma série histórica de pacientes submetidos a implante de SES (n igual 30) ou controle (n igual 15). As características clínicas e angiográficas foram semelhantes entre os grupos , exceto pela maior quantidade de lesões tipo C e mulheres no grupo dos stents eluidores de BA9. Resultados: Aos seis meses de seguimento, a perda tardia intra-stent foi significativamente inferior...

Introduction: Sirolimus-eluting stents (SES) significantly reduce restenosis and major adverse cardiac events (MACE) compared to bare metal stents (BMS). The novel sirolimus analog, Biolimus A9T (BA9), presented similar safety and efficacy in the randomized, controlled STEALTH I trial. This study compared the efficacy of a BA9-eluting stent versus sirolimus-eluting and bare metal control stents. Methods: Forty-five patients with de novo coronary lesions were randomly assigned in a 2:1 basis to receive either BA9-eluting (n = 30) or bare metal (n=15) S-stents. Quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS), at 6 months, were then compared to a matched series of patients who received either sirolimus-eluting (n = 30) or bare metal (n = 15) Bx Velocity stents. Baseline clinical and angiographic characteristics were similar among all groups, except for a significantly higher percentage of females and Class C lesions in the BA9-eluting stent group. Results: At 6 month follow-up, there was no significant difference in clinical outcomes between any of the groups. QCA revealed significantly lower late loss in both drug-eluting stents (DES) groups compared to bare metal controls, but no significant difference between BA9 and SES groups was observed (0.24 ± 0.39mm vs. 0.15 ± 0.38mm, p = NS). Obstruction volume measured by 3D IVUS was significantly reduced in both DES groups compared to bare metal controls, but did not differ between the BA9 and SES groups (2.23% vs. 3.30%, BA9 vs. SES, p=NS). Conclusions: BA9-eluting stents reduce neointimal hyperplasia, safely and effectively, compared to BMS, and the magnitude of this inhibition is similar to that of SES.

Terapia de recanalização endovascular de oclusão da artéria carótida em paciente com acidente vascular cerebral agudo / Percutaneous recanalization of carotid artery occlusion in patient with and acute stroke

Relatamos o caso de uma paciente de 69 anos, que, após a realização de arteriografia carotídea apresentou trombose sintomática da bifurcação carotídea. A paciente foi submetida imediatamente a reperfusão endovascular mecânica, com implante bem-sucedido de stent carotídeo, obtendo reversão completa do déficit neurológivo.

A 69 year-old woman developed symptomatic internal carotid artery thrombosis after carotid angiography. She was immediately submitted to mechanical endovascular reperfusion with successful carotid stent implantation and complete neurological recovery.

Incidência de aposição incompleta persistente e tardia após implante de stents com sirolimus e zotarolimus / Incidence of persistent and late-acquired incomplete stent apposition after sirolimus and zotarolimus-eluting stents

Introdução: Aposição incompleta (AI) é descrita após implante de stents farmacológicos (SF) e pode associar-se à trombose de stents. Em razão de diferentes plataformas, polímeros e fármacos utilizados, diferenças na eficácia e na segurança entre SF também são esperadas. Objetivo: Avaliar a incidência de AI persistente e tardia após implante de stents com sirolimus (SES) e com zotarolimus (ZES) e a evolução dos pacientes que apresentem essa alteração. Método: Análise de 242 pacientes tratados com SF (175 pacientes com SES – Cypher® – e 67 pacientes com ZES – Endeavor™) e submetidos a ultra-sonografia intracoronária após o implante e aos seis meses. Resultados: No grupo tratado com SES, 7 (4%) pacientes apresentaram AI tardia e 12 (6,8%), AI persistente. No grupo tratado com ZES, nenhum caso de AI tardia foi identificado e, em 4 pacientes, observou-se AI após o implante e que desapareceu aos seis meses. Nos pacientes com AI tardia, observou-se aumento evolutivo dos volumes do vaso (de 377,2 ± 148,9 mm3 para 431,9 ± 155,1 mm3; p = 0,51)e da placa (de 206,1 ± 51,5 mm3 para 236,9 ± 68,4 mm3; p = 0,36). O volume de hiperplasia intimal foi maior após ZES (16,6 ± 5,8 mm3 vs. 5,1 ± 5,5 mm3; p < 0,0001). Após nove meses, não ocorreram eventos cardíacos adversos nos pacientes com AI. Conclusão: A incidência de AI tardia foi de 2,9% e observada após SES. A presença de AI não esteve relacionada a eventos adversos a médio prazo.

Background: Incomplete stent apposition (ISA) has been documented after drug-eluting stents (DES) and could be related to stent thrombosis. Because DES differ in metal platform, polymer and pharmacological agent, differences in performance and safety are expected. Objective: We sought to investigate the frequency and clinical consequences of ISA after implantation of sirolimus- (SES) and zotarolimuseluting stents (ZES). Methods: 242 patients (pts) who underwent DES placement (175 pts with Cypher® and 67 pts with EndeavorTM stents) had serial intravascular ultrasound (IVUS) performed (at index procedure and after 6-months). Results: 7 pts (4%) had late-acquired ISA after SES. Another 12 (6.8%) pts treated with SES had persistent ISA. Among pts treated with ZES, none had late ISA and 4 had ISA observed after stent implantation that completely resolved at 6-months. There was an increase in vessel (377.2 ± 148.9 to 431.9 ± 155.1 mm3, p = 0.51) and in plaque volume (206.1 ± 51.53 to 236.91 ± 68.4 mm3, p=0.36) in pts with late ISA. Amount of neointimal hyperplasia was significantly higher in ZES than SES (16.6 ± 5.8 mm3 vs 5.1 ± 5.5 mm3, p < 0.0001). After 9 months, no adverse clinical event was observed in pts with ISA. Conclusion: Overall incidence of IVUS-detected late incomplete DES apposition was 2.9%, all after SES. The presence of ISA was not related to clinical adverse events during mid term follow-up.

Use of drug-eluting stents in Brazil: the CENIC (National Registry of Cardiovascular Interventions) registry / Perfil de uso dos stents farmacológicos no Brasil: dados da Central Nacional de Intervenções Cardiovasculares (CENIC)

FUNDAMENTO: Os stents farmacológicos (SF) foram um grande avanço no tratamento da cardiopatia isquêmica, mas críticas têm sido feitas à extrapolação dos resultados favoráveis de ensaios clínicos para a prática clínica diária. OBJETIVO: Avaliar o uso dos stents farmacológicos (SF) no Brasil, entre os anos de 2000 e 2005. MÉTODOS: Por meio do banco de dados da Central Nacional de Intervenções Cardiovasculares (CENIC), da Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista, foram analisados todos os procedimentos com uso de SF entre os anos de 2000-2005. Os grupos foram divididos nos biênios (2000-2001(A), 2002-2003 (B) e 2004-2005(C)), e as características clínicas, angiográficas e os desfechos foram comparados. Análise estatística foi realizada com teste quiquadrado ou ANOVA, sendo significativo p<0,05. RESULTADOS: No período estudado foram avaliados 154.406 procedimentos, e os SF foram utilizados em 10.426 intervenções (7 por cento do total). Observou-se progressivo e estatisticamente significativo aumento uso dos SF no período analisado: 0,14 por cento em 2000-2001, 5 por cento em 2002-2003, e 14 por cento em 2004-2005 (p<0,0001). Após 2001, observou-se aumento dos índices de sucesso (96,58 por cento em 2000-2001 (A), 99,69 por cento em 2002-2003 (B) e 99,56 em 2004-2005 (C), A x B com p<0,001; B x C com p=0,015) e redução nas taxas de óbito hospitalar (1,59 por cento no grupo A, 0,38 por cento no grupo B, 0,66 por cento no grupo C, p=0,59 para A x B; e p<0,0001 para B x C). CONCLUSÃO: O uso dos SF no Brasil cresceu significativamente nos últimos anos, com melhora dos índices de sucesso e diminuição do óbito hospitalar.

BACKGROUND: Drug-eluting stents (DES) represent a major advance in the management of ischemic heart disease, but the extrapolation of favorable results from clinical trials to the real-world practice has been criticized. OBJECTIVE: To assess the use of DES in Brazil between 2000 and 2005. METHODS: Using the database of the National Registry of Cardiovascular Interventions (CENIC - Central Nacional de Intervenções Cardiovasculares) of the Brazilian Society of Hemodynamics and Interventional Cardiology (SBHCI - Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista), all PCI procedures with DES implantation performed between 2000 and 2005 were analyzed. The groups were divided into the following biennia: 2000-2001(A), 2002-2003 (B), and 2004-2005 (C), and patient's clinical and angiographic characteristics were compared, as well as their short-term clinical outcome. Statistical analyses were performed using the chi-square test or ANOVA, and p values of less than 0.05 were considered to be statistically significant. RESULTS: A total of 154,406 PCI procedures were studied, and DES was used in 10,426 (7 percent) interventions. A progressive and statistically significant increase was found in the use of DES during the period studied: 0.14 percent from 2000 to 2001, 5 percent from 2002 to 2003, and 14 percent from 2004 to 2005 (p < 0.0001). After 2001, there was an increase in success rates (96.58 percent in 2000-2001 (A), 99.69 percent in 2002-2003 (B), and 99.56 percent in 2004-2005 (C), A x B with p < 0.001; B x C with p = 0.015) and a decrease in hospital mortality rates (1.59 percent in group A, 0.38 percent in group B, and 0.66 percent in group C, with p = 0.59 for A x B and p < 0.0001 for B x C). CONCLUSION: In Brazil, the use of drug-eluting stents increased significantly during recent years, resulting in higher success rates and lower hospital mortality.

asociación entre la concentración de plasmática de proteina C reactiva y el volumen de hiperplasia neointimal en pacientes tratados con implante de stent liberador de zotarolimus. Análisis volumétrico con ecografía intracoronariana tridimensional / Relationship between plasma C-reactive protein level and neointimal hyperplasia volume in patients with zotarolimus-eluting stents. Volumetric analysis by three-dimensional intracoronary ultrasound

INTRODUCTION AND OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Análise comparativa do segmento de "ovelapping" dos stents liberadores de sirolimus e paclitaxel / Comparative analysis of the overlapping segment of sirolimus-versus paclitaxel-eluting stents

Introdução: No tratamento de obstruções coronárias longas e complexas recomenda-se cobertura total da lesão. Quando mais de um stent é implantado, torna-se mandatário um "overlapping" ou sobreposição dos stents para evitar espaços não cobertos entre eles. Há pouca evidência na literatura sobre a eficácia e segurança de se realizar sobreposição de stents liberadores de sirolimus (Cypher, SES) e paclitaxel (Taxus, SEP). Objetivo: Avaliar, por meio de estudo seriado com ultra-sonografia intravascular (USIC), a eficácia na redução da proliferação neointimal e as mudanças na parede vascular no segmento com sobreposição de stents farmacológicos SES e SEP. Método: Um total de 52 pacientes (72 lesões) foram prospectivamente incluídos nesta análise e randomizados para tratamento percutâneo com implante de SES ou SEP. Cartoze pacientes do grupo SES e 12 do grupo SEP apresentaram segmentos de sobreposição. Angiografia Coronária quantitativa e USIC foram realizados imediatamente após o implante dos stents e repetidos após oito meses. Resultados: Ambos os grupos apresentavam características clínicas e angiográficas basais...

Introduction: To treat long complex coronary obstructions, total lesion coverage is recommended. When more than one stent is deployed an overlap segment is mandatory to avoid uncovered gaps between stents. There is no data comparing Sirolimus- (SES) versus Paclitaxel-eluting stents (PES) at overlapping segments in regards to neointimal inhibition or toxic effects on the vessel wall. Objective: To evaluate, by means of serial intravascular ultrasound (IVUS), the efficacy in reducing neointimal proliferation and the vessel changes in the overlapping segment comparing these two drug-eluting stents. Method: Fifty-two patients with 72 de novo coronary lesions were randomized for SES or PES. Fourteen patients in the SES Group and twelve in the PES Group had overlapping segments. Quantitative coronary angiography and IVUS were performed at the time of the procedure and at 8 months follow-up. Results: No significant baseline differences were identified between the 2 groups. The mean stent/lesion ratios were similar (1.74 ± 0.89 for SES vs. 2.01 ± 0.92 for PES; p= 0.47). SES and PES were comparable in reducing neointima hyperplasia in the overlapping zone (neointima volume 2.24 ± 0.9 mm3 after SES vs. 2.53 ± 1.5 mm3 after PES; p=0.1 and % neointima obstruction of 18.15 ± 8.5% after SES vs. 26.7 ± 16.8% after PES; p=0.1). There was no positive remodeling in the overlapping segment for both groups (expansion ratio 0.74 ± 0.18 vs. 0.76 ± 0.14, respectively; p=0.74). Other IVUS volumetric measurements were also equivalent between the two cohorts. Conclusion: In our preliminary experience, overlapping of DESs proved...

Late incomplete apposition after drug-eluting stent implantation: incidence and potential for adverse clinical outcomes

Aim Late acquired incomplete stent apposition (ISA) has been documented after drug-eluting stent (DES) implantation; However, its clinical consequences of late ISA after implantation sirolimus - (SES) or paclitaxel-eluting stent (PES) in a non-elected population. Methods and Results From our database, we analysed 195 consecutive patients who underwent DES placetement(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 mounths (median of 24.3 months, interquartile range 18.1 - 31.6 months. They were clinically followed for a 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...

Análise ultra-sonográfica da resposta vascular tardia das bordas de stents liberadores de drogas análogas ao sirolimus: comparação entre diabéticos e não-diabéticos / IVUS analysis of the late vascular response at the edges of sirolimus analogue-eluting stents: comparison among diabetic and non-diabetic patients

Introdução: A resposta vascular dos segmentos adjacentes aos stents liberadores de medicamentos continua sendo objeto de estudo, principalmente nos pacientes diabéticos (DM), nos quais a progressão da aterosclerose é mais freqüentemente observada. Recentemente, os fármacos Biolimus e Zotarolimus demonstraram eficácia semelhante ao Sirolimus na redução da hiperplasia intimal intra-stent. Objetivo: Comparar a resposta vascular tardia nas bordas proximais (BP) e distais (BD), entre DM e não-diabéticos (NDM) tratados com stents liberadores de sirolimus ou fármacos análogos (Biolimus e Zotarolimus), avaliada pelo ultra-som intracoronário (USIC). Método: Foram incluídos 153 pacientes (306 bordas) tratados com stents (53% Sirolimus, 26% Zotarolimus e 21% Biolimus) e divididos em dois grupos em relação à presença de diabetes: DM, 122 bordas e NDM, 166 bordas; 18 bordas foram excluídas. As análises pelo USIC foram realizadas nos 5 mm proximal e distal aos stents após o implante (basal) e no seguimento tardio (± 6 meses). Os volumes do vaso (VV), do lúmen (VL) e da placa (VP) foram calculados pela regra de Simpson. A porcentagem de obstrução (% Obs) e a variação dos volumes (Delta - Δ) entre seguimento e basal foram também calculados. Reestenose das bordas foi definida como uma obstrução >50% no seguimento. Resultados: A media para idade foi 58±9 anos, sendo 59% do sexo masculino. Não houve diferença nas características basais dos grupos...

Introduction: Late vascular response of the segments adjacent to proximal and distal edges of the drug-eluting stents is still not well established, particularly in diabetic patients who are prone to atherosclerosis plaque progression. Recently, new sirolimus-analogue eluting stents (Biolimus and Zotarolimus) have demonstrated potent antiproliferative effects. Objective: To compare the late vascular responses at proximal (PE) and distal (DE) edges of sirolimus analogue-eluting stents in patients with and without diabetes (DM or NDM) using intravascular ultrasound (IVUS). Method: 306 IVUS edge analyses were performed in 153 patients treated with drug-eluting stents(53% Sirolimus, 26% Zotarolimus, 21% Biolimus). Patients were divided in two groups: DM, 122 edges and NDM, 166 edges; 18 edges were excluded. IVUS analyses were performed post-intervention (PI) and after 6-month follow-up (FU) and included 5 mm distal and proximal to the stented segment. Vessel, lumen and plaque volumes were calculated by Simpon’s rule. Percentage of obstruction and volumes changes (FUminus PI values) were also calculated. Edge restenosis was defined as obstruction >50% at FU. Results: The mean age was 58±9 y, and 59% were male. The baseline characteristics were similar between groups. In both groups, the entire lesion length was totally covered (stent length / lesion length was 1.51 and 1.52). There were no significant differences in edge volumes between the two groups...

Comparison between sirolimus-eluting stents and intracoronary catheter-based beta radiation for the treatment of in-stent restenosis

We report the outcomes of patients who had in-stent restenosis (IRS) that was treated with intravascular brachytherapy (IVBT) or sirolimus-eluting stent (SES) implantation. The benefit of IVBT for treating ISR is well documented. SES implantation decreases first-time ISR and, in preliminary reports, has been used to treat ISR. Fifty consecutive patients who had ISR were treated; the first 25 patients underwent SES implantation and the next 25 patients were treated with IVBT using a -Cath System (a 40-mm strontium-90/yttrium-90 source). Quantitative angiographic and intravascular ultrasound follow-up were performed at 5.2 1.1 and 12.1 1.2 months; clinical follow-up was performed at 15 months. SES deployment and IVBT were successful in all patients. At 12-month follow-up, 8 patients who underwent IVBT had angiographic recurrence (4 in the stent and 4 at the stent edge); only 1 patient who underwent SES implantation developed recurrent ISR. At 12 months, in-stent late luminal loss was similar between the SES and IVBT groups (0.35 0.45 vs 0.34 0.46 mm, p 0.9); however, in-stent net luminal gain was higher in the SES group than in the IVBT group (1.32 0.13 vs 0.57 0.19 mm, p <0.0001), and in-lesion late luminal loss was higher in the IVBT group (0.48 0.32 vs 0.16 0.42 mm, p 0.004). At 12 months, intravascular ultrasound stent volume obstruction was higher after IVBT versus than after SES implantation (38.7% vs 6.7%, p <0.0001). At 15-month clinical follow-up, 64% and 96% (p <0.01) of patients who underwent IVBT and SES implantation, respectively, were free of major adverse cardiac events. In conclusion SES implantation for the treatment of ISR was effective and superior to catheter-based IVBT in preventing recurrent neointimal proliferation and angiographic restenosis at 1-year follow-up.

Pilot study with an intensified oral sirolimus regimen for the prevention of in-stent restenosis in de novo lesions

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

patients. The reference diameter was 3.04 6 0.38 mm, and the lesion length was

14 6 2 mm. Angiographic and volumetric intravascular ultrasound (IVUS) analyses were

performed in all patients at 6.0 6 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 6

0.31 mm and 0.67 6 0.45 mm, respectively, and the percent neointimal volume was

infarctions, or target lesion revascularizations were detected. Mean sirolimus

blood level was 13 6 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

encourage further trials evaluating the current protocol for the prevention of in-stent

for de novo lesions. Mean patient age was 59 6 9; 73% were male, and 13% were diabetic

parameters of restenosis after stent implantation in de novo lesions when compared

with historic controls. Considering the efficacy/safety balance, our results do not

IMPACT trial: angiographic and intravascular ultrasound observations of the first human experience with mycophenolic acid-eluting polymer stent system

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 5 50) and second (n 5 55) groups received moderate- and slow-release MPA-eluting Duraflex stent, respectively. The last group (n 5 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 MPAeluting 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.

Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents

Background—Despite the proven superiority of sirolimus-eluting stents (SES) 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 totalpopulation (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 sirolimuseluting 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).

Braquiterapia intracoronariana. Tratamento da reestenose intra-stent com o sistema Beta-Cath: experiência inicial na América Latina / Intracoronary brachytherapy. Treatment of in-stent restenosis with the Beta-Cath system: initial experience in Latin America

OBJETIVO: Avaliar a segurança e eficácia da braquiterapia intracoronariana usando o sistema Beta-CathTM na prevenção da recorrência de restenose intra-stent (RIS), por meio da análise dos resultados clínicos, angiográficos e pelo ultra-som intracoronariano (USIC). MÉTODO: Foram submetidos à angioplastia com cateter-balão, seguida de beta-radiação intracoronariana com o sistema Beta-CathTM (90Sr/Y) 30 pacientes com RIS em artérias coronárias nativas e, posteriormente, avaliados. RESULTADOS: Incluíram-se lesões reestenóticas complexas (77 por cento do tipo difuso-proliferativo) com extensão elevada (18,66±4,15 mm). O sucesso da braquiterapia foi de 100 por cento. A dose média utilizada foi de 20,7±2,3 Gy, liberada em um período médio de 3,8±2,1 min. No seguimento tardio, o diâmetro luminal mínimo (DLM) intra-stent diminuiu discretamente (1,98±0,30mm para 1,84±0,39 aos 6 meses, p=0,13), com uma perda tardia de 0,14±0,18 mm. O DLM intra-segmentar foi significativamente menor do que o intra-stent (1,55±0,40mm vs.1,84±0,39mm, p=0,008), associando-se à perda tardia (0,40±0,29mm vs. 0,14±0,18mm; p=0,0001). No USIC, observou-se discreto incremento do tecido neointimal em 6,8±14,3 mm aos 6 meses (p=0,19) e a percentagem de obstrução volumétrica aumentou em 4,7±7,5 por cento. A reestenose binária e a revascularização do vaso-alvo recorreram em 17 por cento dos casos; houve 1 caso (3 por cento) de oclusão tardia, associada a infarto do miocárdio. A sobrevida livre de eventos foi de 80 por cento. CONCLUSAO: O manejo da reestenose intra-stent com a beta-radiação intracoronariana mostrou-se procedimento seguro e eficaz, com alta taxa de sucesso imediato, representando uma opção terapêutica para a inibição da hiperplasia neointimal.