Vessel remodeling and plaque distribution in side branch of complex coronary bifurcation lesions: a grayscale intravascular ultrasound study.

To investigate vessel remodeling and plaque distribution in side branch (SB) of true coronary bifurcation lesions with SB disease extending from its ostium. A total of 62 patients with single de novo true bifurcation lesions with SB with severe and extensive disease were enrolled. Of that, 45 patients/lesions underwent pre-intervention intravascular ultrasound (IVUS) at the SB. Left anterior descending was the most prevalent target vessel (>85%). All lesions had significant involvement of both branches of the bifurcation, and the majority were classified as type 1,1,1 according to the Medina classification. Considering the subset with IVUS imaging, mean lesion length, reference diameter and % diameter stenosis in the SB were 8.88 ± 4.61 mm, 2.68 ± 0.59, and 70.2 ± 16.0%, respectively. Also, mean proximal (take-off) and distal (carina) angles were 142.3 ± 21.9° and 60.7 ± 22.4°, respectively. At minimum lumena area (MLA) site, mean external elastic membrane and MLA cross-sectional areas were 6.70 ± 2.08 and 1.87 ± 0.93 mm2, respectively; given that the mean distance measured between the SB origin and MLA site was <1 mm. In addition, mean plaque burden was 67.9% and mean remodeling index was 0.78 ± 0.21. Importantly, only 9 cases out of 45 presented remodeling index > 1.0. Also, plaque distribution analysis within the SB ostium demonstrated preferable plaque positioning in the opposite side to the flow divider. In conclusions, significant negative remodeling is a frequent encounter in SB of complex coronary bifurcation lesions presenting with extensive and severe disease; in addition, plaque distribution in the SB ostium appears to be asymmetric in relation to the parent vessel, as plaque burden is mostly found in regions of low wall shear stress including the opposite side to the flow divider within the bifurcation anatomy.

Vessel remodeling and plaque distribution in side branchof complex coronary bifurcation lesions: a grayscaleintravascular ultrasound study

To investigate vessel remodeling and plaquedistribution in side branch (SB) of true coronary bifurcationlesions with SB disease extending from its ostium. A total of62 patients with single de novo true bifurcation lesions withSB with severe and extensive disease were enrolled. Of that,45 patients/lesions underwent pre-intervention intravascularultrasound (IVUS) at the SB. Left anterior descending wasthe most prevalent target vessel ([85 %). All lesions hadsignificant involvement of both branches of the bifurcation,and the majority were classified as type 1,1,1 according to theMedina classification. Considering the subset with IVUSimaging, mean lesion length, reference diameter and %diameter stenosis in the SB were 8.88 ± 4.61 mm,2.68 ± 0.59, and 70.2 ± 16.0 %, respectively. Also, meanproximal (take-off) and distal (carina) angles were142.3 ± 21.9 and 60.7 ± 22.4 , respectively. At minimumlumena area (MLA) site, mean external elastic membraneand MLA cross-sectional areas were 6.70 ± 2.08 and1.87 ± 0.93 mm2, respectively; given that the mean distancemeasured between the SB origin and MLA site was/1 mm. In addition, mean plaque burden was 67.9 % andmean remodeling index was 0.78 ± 0.21. Importantly, only9 cases out of 45 presented remodeling index [1.0.Also, plaque distribution analysis within the SB ostium demonstrated preferable plaque positioning in the oppositeside to the flow divider. In conclusions, significant negativeremodeling is a frequent encounter in SB of complex coronarybifurcation lesions presenting with extensive and severedisease; in addition, plaque distribution in the SB ostiumappears to be asymmetric in relation to the parent vessel, asplaque burden is mostly found in regions of low wall shearstress including the opposite side to the flow divider withinthe bifurcation anatomy.

Seguimento angiográfico e clínico tardio do novo stent farmacológico não-polimérico liberador de paclitaxel para o tratamento de lesões coronárias De Novo: resultados do Estudo PAX-B / Late clinical and angiographic follow-up of the new non-polymeric paclitaxel-eluting stent for the treatment of De Novo coronary lesions: outcomes of the PAX-B Study

Introdução: O stent farmacológico eluidor de paclitaxel, não-polimérico, Amazonia® PAX não mostrou diferença na reestenose coronária ou eventos clínicos aos 4 meses de evolução quando comparado com o stent Taxus®. Entretanto, o desempenho do stent Amazonia® PAX em cenários de maior complexidade e com seguimento angiográfico mais longo ainda não foi demonstrado. Métodos: O Estudo PAX-Bfoi um estudo prospectivo, não-randomizado, multicêntrico, que avaliou os resultados tardios de pacientes tratados com o stent Amazonia® PAX. O desfecho primário foi a perda tardiado lúmen intrastent. Resultados: Foram incluídos 103 pacientes com média de idade de 61,3 ± 11,4 anos, 26,2% eramdiabéticos, 24,3% apresentaram-se com síndrome coronária aguda e 71,6% tinham lesões tipo B2/C. Implante de múltiplos stents ocorreu em 4,7% dos casos e o sucesso angiográfico foi de 100%. Na fase hospitalar, a taxa de infarto agudo do miocárdio periprocedimento foi de 3,9%, e um desses eventos levou à revascularização da lesão-alvo (RLA). No seguimento angiográfico de 9 meses, a mediana da perda tardia do lúmen intrastent foi de 0,91 [0,50; 1,21] mm. As taxas cumulativas de eventos cardíacos adversos maiores nos seguimentos de 6meses, 9 meses e 12 meses foram, respectivamente, de 7,8%, 18,5% e 21,3%, principalmente em decorrência de RLA. Não se observou morte ou trombose de stent em 12 meses.Conclusões: O stent Amazonia® PAX demonstrou excelentes resultados imediatos e alto perfil de segurança. Entretanto, as taxas de recorrência angiográfica foram relativamente altas,em razão da pouca eficácia na inibição da formação de hiperplasia neointimal.

Impacto da pré-dilatação do ramo lateral no procedimento de intervenção coronária percutânea em lesões de bifurcação coronária complexas / Impact of side branch predilation on percutaneous coronary intervention in complex coronary bifurcation lesions

Introdução: O tratamento de lesões de bifurcação com implante de stent único no vaso principal e stent provisional no ramo lateral pode ser limitado pelo grau de complexidade anatômica/morfológica da lesão. A pré-dilatação do ramo lateral, um passo do procedimento geralmente evitado, pode ser necessária para manter a patência do ramo lateral. Investigamos o impacto da pré-dilatação do ramo lateral nos resultados imediatos de intervenção coronária percutânea em lesões de bifurcação coronária complexas. Métodos: Entre maio de 2008 e agosto de 2009, 59 pacientes com lesão de bifurcação coronária única e comprometimento significativo de vaso principal e ramo lateral foram incluídos no estudo. Os principais critérios de exclusão foram: envolvimento do tronco de coronária esquerda, infarto agudo do miocárdio com elevação do segmento ST(< 72 horas) e reestenose intrastent. Resultados: A média de idade foi de 61,2 ± 11 anos, 25,4% eram do sexo feminino e 30,1% tinham diabetes. As lesões mais frequentemente se localizaram em artéria descendente anterior/ramo diagonal (86,4%). Durante o procedimento, 8,5% (5/59) das lesões tiveram pré-dilatação do ramo lateral sem sucesso, e 4 dessas bifurcações foram tratadas com 2 stents. No modelo multivariado, a estenose do ramo lateral no pré-procedimento foi o único preditor significativo de pré-dilatação sem sucesso do ramo lateral (odds ratio 1,15, intervalo de confiança de 95%1,01-1,30; P = 0,04), e estenose > 87,6% no ramo lateral foi identificada na curva ROC como valor de corte com maior acurácia para predizer o insucesso. Conclusões: A pré-dilatação do ramo lateral esteve associada a falência imediata do ramo lateral em < 10% dos casos e o único preditor significativo na análise multivariada foi a gravidade da estenose (> 85%)no ramo lateral no pré-procedimento.

Incidência, manejo e prognóstico de perfurações coronárias / Incidence, management and prognosis of coronary perforations

INTRODUÇÃO: A perfuração coronária na atualidade é complicação rara, mas potencialmente catastrófica. Nosso objetivo foi avaliar a incidência, os preditores, o manejo e o prognóstico das perfurações coronárias na experiência de um serviço de cardiologia intervencionista com grande volume de intervenções coronárias percutâneas (ICPs). MÉTODOS: Comparamos as características clínicas, angiográficas e do procedimento e a evolução intra-hospitalar de pacientes que apresentaram ou não perfuração coronária. Análise univariada foi realizada para determinar os preditores dessa complicação. RESULTADOS: No período de dezembro de 2007 a janeiro de 2012, 5.585 pacientes consecutivos foram submetidos a ICP e 18 apresentaram perfuração coronária (0,32%), dos quais 55,5% eram do sexo feminino e 38,9% eram diabéticos. Nesse grupo, a artéria descendente anterior foi o vaso mais frequentemente tratado (61,1%), assim como a lesão do tipo C (61,1%), e as oclusões crônicas foram abordadas em 27,8% desses casos. A maioria das perfurações coronárias (11/18) apresentou menor complexidade de acordo com a classificação de Ellis modificada, enquanto as demais foram qualificadas como graus III (6/18) ou IV (1/18). O cateter-balão foi o dispositivo responsável pela perfuração em 61,1% dos casos. Realizou-se insuflação prolongada com cateter-balão e inativação da heparina com protamina em 72,2% e 88,9% dos casos, respectivamente. Apenas 1 paciente (5,6%) necessitou de abordagem cirúrgica de emergência em decorrência de tamponamento cardíaco. Não houve óbito associado à perfuração coronária. Na análise univariada, os preditores de perfuração coronária foram: sexo feminino (P = 0,03), doença pulmonar obstrutiva crônica (P = 0,006) e oclusão crônica (P < 0,01). CONCLUSÕES: Em nossa experiência, a perfuração coronária foi evento raro, controlada conservadoramente na maioria dos casos e com evolução hospitalar satisfatória.

BACKGROUND: Coronary perforation is currently a rare, but potentially catastrophic complication. The aim of the study was to evaluate the incidence, predictors, management and prognosis of coronary perforations at a hospital with a large number of percutaneous coronary interventions (PCIs). METHODS: Clinical, angiographic, procedural and in-hospital outcomes of patients with or without coronary perforations were compared. Univariate analysis was performed to determine the predictors of this complication. RESULTS: From December 2007 to January 2012, 5,585 consecutive patients were submitted to PCI and 18 had coronary perforation (0.32%), of whom 55.5% were female and 38.9% were diabetic. In this group, the left anterior descending artery was the most frequently treated vessel (61.1%) as well as type C lesion (61.1%) and chronic occlusions were approached in 27.8% of these cases. Most of the coronary perforations (11/18) had a lower complexity according to the modified Ellis classification, whereas the remaining perforations were classified as grades III (6/18) or IV (1/18). The balloon-catheter device was responsible for perforation in 61.1% of the cases. Prolonged inflation with a balloon-catheter and heparin reversal with protamine was performed in 72.2% and 88.9% of the cases, respectively. Only 1 patient (5.6%) required an emergency surgery due to cardiac tamponade. There were no deaths associated with coronary perforation. According to the univariate analysis, coronary perforation predictors were: female gender (P = 0.03), chronic obstructive pulmonary disease (P = 0.006) and chronic occlusion (P < 0.01). CONCLUSIONS: In our experience, coronary perforation was a rare event, which was managed conservatively in most of the cases and was associated with a good in-hospital outcome.

Angiographic and intravascular ultrasound findings following implantation of the Endeavor zotarolimus-eluting stents in patients from the real-world clinical practice.

AIMS: The aim of this study was to investigate the angiographic and intravascular ultrasound (IVUS) findings of the Endeavor zotarolimus-eluting stent (ZES) in patients from a "real-world" clinical practice. METHODS AND RESULTS: From January to March 2006, 100 patients undergoing routine or emergency percutaneous intervention were prospectively enrolled at one institution. Overall, 39% of the patients were diabetics and 80.8% of lesions were type B2/C. A total of 140 lesions were successfully treated with 174 ZES, and procedural success was 98%. Mean vessel diameter was 2.69 mm and mean lesion length was 16.0 mm; at 6-month angiographic follow-up (completed in 96%), in-stent late lumen loss was 0.66 mm, and in-segment restenosis was 8.2%. Angiographic restenosis was increased among diabetics (15.5 vs. 2.6%, p=0.009), and diabetes was the only significant predictor of angiographic restenosis (OR=15.27 [95%CI 2.45-95.04], p=0.003). By IVUS (performed in 88% at 6-month), % volume obstruction was 14.4+/-13.4%, and there was no late acquired incomplete stent apposition (ISA). At 1-year, overall MACE rate was 6%, including 5 TLRs (4% of patients), with no occurrence of stent thrombosis. CONCLUSIONS: In this prospective "real-world" experience, the ZES demonstrated favourable angiographic and IVUS results in complex patients, with overall in-stent late lumen loss of 0.66 mm, and absence of late acquired ISA. At 1-year, there were no safety concerns including absence of death and stent thrombosis.

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...

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

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.

Asociación entre la concentración plasmática de proteína C reactiva y el volumen de hiperplasia neointimal en pacientes tratados con implante de stent liberador de zotarolimus. Análisis volumétrico con ecografía intracoronaria 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

Introducción y objetivos. La proteína C reactiva (PCR) es un marcador inflamatorio predictor de eventos cardiacos en los síndromes coronarios; sin embargo, existe evidencia contradictoria sobre su relación con la reestenosis intra-stent. El objetivo es evaluar la asociación entre la concentración sérica de PCR basal y el volumen de hiperplasia neointimal por ecografía intracoronaria a los 4 meses tras el implante de stents con zotarolimus. Métodos. Se incluyó a 40 pacientes tratados consecutivamente con stent liberador de zotarolimus. Se determinó el valor de PCR antes del procedimiento y de acuerdo con éste se agrupó a la población en cuartiles. Se realizó ecografía intracoronaria tras el implante y a los 4 meses, evaluando el volumen de hiperplasia neointimal por la fórmula de Simpson. Para relacionar las variables se utilizaron análisis de correlación y regresión lineal. Se realizó un análisis de regresión múltiple de las variables relacionadas de forma independiente con el volumen neointimal. Resultados. La edad media fue 58 ± 8 años, el 55% eran varones y el 40% tenía diabetes, sin diferencias en las características basales entre los grupos. El volumen de hiperplasia fue 4,8 ± 4,2 µl y 15,8 ± 10 µl para el primer y el cuarto cuartil respectivamente (p < 0,001). Existió correlación positiva entre la PCR y el volumen neointimal (r = 0,64; p = 0,0001). La PCR, el volumen luminal postimplante y la presión de liberación fueron predictores independientes de hiperplasia neointimal. Conclusiones. En este estudio observamos que el valor de la PCR antes del implante de stent con zotarolimus se correlacionó de forma independiente con el volumen de hiperplasia neointimal a los 4 meses de seguimiento (AU)

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) µl and 15.8 (10.0) µl 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 (AU)

A three-dimensional intravascular ultrasound comparison between the new zotarolimus-eluting stent (ZoMaxx) and the non-drug-eluting TriMaxx stent.

BACKGROUND: Despite the effectiveness of sirolimus- and paclitaxel-eluting stents in reducing intimal hyperplasia (IH) and the need for repeat revascularization, concerns about their long-term safety have motivated the search for new drug-eluting stents (DES). Recently developed, the ZoMaxx stent combines a sirolimus-analogous agent (zotarolimus), featuring a phosphorycoline polymer and stainless steel and tantalum platform. We sought to assess the efficacy of this new DES in reducing IH. METHODS: A total of 40 patients were treated with the ZoMaxx stent and compared to 50 patients treated with its non-drug-eluting equivalent, the TriMaxx stent. Only single de novo lesions in native coronary vessels greater than or equal to 3.0 mm were enrolled. Serial quantitative coronary angiography and intravascular ultrasound (IVUS) images were obtained at baseline and 6- month follow up. All patients were clinically followed for 1 year. This analysis aimed to compare the percent of IH between the 2 stents. Secondarily, we assessed in-segment late loss, binary restenosis and major adverse cardiac events. RESULTS: Baseline patient and lesion characteristics were comparable between the 2 groups. At follow up, zotarolimus efficiently suppressed neointimal hyperplasia formation with a marked reduction in the percentage of stent obstruction by IVUS (4.6 +/- 3.6% vs. 31.2 +/- 16%; p < 0.0001). Almost 90% of the segments stented with ZoMaxx did not exhibit more than 10% of obstruction. After 1 year, 12 patients treated with the TriMaxx and 2 patients treated with the ZoMaxx presented in-segment binary restenosis (p = 0.03). CONCLUSIONS: In this initial experience, ZoMaxx proved to be clinically safe and superior to its non-drug-coated equivalent in reducing in-stent IH formation and restenosis.

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 vascular response at the edges of sirolimus analogous-eluting stents in diabetic patients: An intravascular ultrasound study.

INTRODUCTION: Vascular response at edges of drug-eluting stents is still not well established, particularly in diabetic patients who are prone to aggressive atherosclerosis progression. Recently, Biolimus and Zotarolimus have demonstrated potent antiproliferative effects. OBJECTIVE: To compare the vascular responses at edges of sirolimus analogous-eluting stents in patients with and without diabetes, using intravascular ultrasound (IVUS). METHODS: 306 edges were analyzed in 153 patients treated with drug-eluting stents and divided in: diabetics (122 edges) and nondiabetics (166 edges). IVUS was performed postintervention and at 6-month follow-up and included 5 mm distal and proximal to the stented segment. Vessel, lumen, and plaque volumes were calculated. Volume variation (follow-up minus basal) was also calculated. Edge restenosis was defined as obstruction >50%. RESULTS: Baseline characteristics were similar between groups. In both groups the entire lesion length was covered (stent length/lesion length ratio was 1.5 for both groups). There were no differences in edge volumes and restenosis rate between the groups. Among diabetics, there was no significant volume variation. However, in nondiabetic patients there was significant increase in vessel volume in proximal (from 67.1 +/- 22 mm(3) to 72.2 +/- 25 mm(3): P = 0.02) and distal (from 54.4 +/- 22 mm(3) to 59.8 +/- 22 mm(3): P = 0.001) edges. CONCLUSION: Nondiabetic patients showed a significant positive vascular remodeling in proximal and distal edges of sirolimus analogous-eluting stent. This vascular mechanism was not observed in diabetic patients. Although different vascular responses were observed, restenosis rates were equivalent between the 2 groups at 6-month follow-up.

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 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 mm(3) and 7.4 +/- 11 mm, respectively. There was a marked increase in vessel volume from 416.0 +/- 163.9 mm(3) at baseline to 514.4 +/- 247.9 mm(3) at follow-up (P = 0.001) with no significant change in plaque volume (232.4 +/- 52.7 at baseline and 226.4 +/- 22.3 mm(3) 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.

Late vascular response at the edges of sirolimus analogous-eluting stents in diabetic patients

Introduction: Vascular response at edges of drug-eluting stents is still not well established, particularly in diabetic patients who are prone to aggressive atherosclerosis progression. Recently, Biolimus and Zotarolimus have demonstrated potent antiproliferative deffects. Objective: To compare the vascular responses at edges of sirolimus analogous-eluting stents in patients with and without diabetes, using intravascular ultrasound (IVUS). Methods: 306 edges were analyzed in 153 patients treated with drug-eluting stents and divided in: diabetics (122 edges) and nondiabetics (166 edges). IVUS was performed postintervention and at 6-month follow-up and included 5 mm distal and proximal to the stented segment. Vessel, lumen, and plaque volumes were calculated. Volume variation (follow-up minus basal) was also calculated. Edge restenosis was defined as obstruction 50%. Results: Baseline characteristics were similar between groups. In both groups the entire lesion length was covered (stent length/ lesion length ratio was 1.5 for both groups). There were no differences in edge volumes and restenosis rate between the groups. Among diabetics, there was no significant volume variation. However, in nondiabetic patients there was significant increase in vessel volume in proximal (from 67.1 6 22 mm3 to 72.2 6 25 mm3: P = 0.02) and distal (from 54.4 6 22 mm3 to 59.8 6 22 mm3: P = 0.001) edges. Conclusion: Nondiabetic patients showed a significant positive vascular remodeling in proximal and distal edges of sirolimus analogous-eluting stent. This vascular mechanism was not observed in diabetic patients. Although different vascular responses were observed, restenosis rates were equivalent between the 2 groups at 6-month follow-up.

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 beta-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.

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

Pilot study with an intensified oral sirolimus regimen for the prevention of in-stent restenosis in de novo lesions: a serial intravascular ultrasound study.

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.

Angiographic and intravascular ultrasound findings of the late catch-up phenomenon after intracoronary beta-radiation for the treatment of in-stent restenosis.

We report one-year angiographic and intravascular ultrasound (IVUS) outcomes of in-stent restenosis (ISR) patients treated with intravascular brachytherapy (IVBT). The benefit of IVBT for treating ISR is well documented. However, few data exist on significant angiographic and intravascular ultrasonic in-stent lumen deterioration beyond the habitual 6-month analysis after the index radiation procedure or so-called late catch-up process in the treatment of ISR. Twenty-five consecutive patients with ISR were treated with IVBT using the Beta-Cath System (a 40 mm 90 Sr per 90 gamma source). Quantitative angiographic and IVUS analysis was performed in all of them at 6 and 12 months. IVBT was successful in all patients. Four patients (16%) developed recurrent angiographic binary restenosis at 6-month follow-up, all located within the adjacent reference segments, with 2 being associated with geographical miss. An additional 4 patients (16%) presented with recurrent ISR at 12-month follow-up, all within the stented segment. Significant in-stent lumen loss (0.16 +/- 0.42 mm to 0.34 +/- 0.46 mm; p = 0.008) and in-stent intimal hyperplasia growth (+11.2 +/- 0.48 mm3; p = 0.03) was observed between 6 and 12 months. Intracoronary beta-radiation for the treatment of ISR was associated with significant luminal deterioration (late catch-up) within the stents between 6 and 12 months due to an important late progression of in-stent intimal hyperplasia.