Intracoronary Stenting and Angiographic Results

Kastrati, Adnan; Mehilli, Julinda; Dirschinger, Josef; Dotzer, Franz; Schühlen, Helmut; Neumann, Franz‐Josef; Fleckenstein, Martin; Pfafferott, C.; Seyfarth, Melchior; Schömig, Albert

doi:10.1161/01.cir.103.23.2816

Cited by 723 publications

(185 citation statements)

References 27 publications

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“…The ISAR-STEREO-I and ISAR-STEREO-II trials were large-scale clinical studies carried out by Pache et al in 2003, respectively, in which over 600 patients were randomly assigned to receive either a thin (0.05 mm) or thick (0.13-0.14 mm) strut stent for the treatment of symptomatic coronary heart disease. 40,68 At 6 month follow-up in both trials, the incidence of angiographic in-stent restenosis was significantly higher (p < 0.05) for patients treated with the thick strut stents. Based on these results, it was concluded that strut thickness has a major impact on the clinical outcome following coronary stent deployment.…”

Section: Discussionmentioning

confidence: 92%

Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis

Martín¹,

Boyle²

2015

Cardiovasc Eng Tech

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Abstract-Several clinical studies have identified a strong correlation between neointimal hyperplasia following coronary stent deployment and both stent-induced arterial injury and altered vessel hemodynamics. As such, the sequential structural and fluid dynamics analysis of balloon-expandable stent deployment should provide a comprehensive indication of stent performance. Despite this observation, very few numerical studies of balloon-expandable coronary stents have considered both the mechanical and hemodynamic impact of stent deployment. Furthermore, in the few studies that have considered both phenomena, only a small number of stents have been considered. In this study, a sequential structural and fluid dynamics analysis methodology was employed to compare both the mechanical and hemodynamic impact of six balloon-expandable coronary stents. To investigate the relationship between stent design and performance, several common stent design properties were then identified and the dependence between these properties and both the mechanical and hemodynamic variables of interest was evaluated using statistical measures of correlation. Following the completion of the numerical analyses, stent strut thickness was identified as the only common design property that demonstrated a strong dependence with either the mean equivalent stress predicted in the artery wall or the mean relative residence time predicted on the luminal surface of the artery. These results corroborate the findings of the large-scale ISAR-STEREO clinical studies and highlight the crucial role of strut thickness in coronary stent design. The sequential structural and fluid dynamics analysis methodology and the multivariable statistical treatment of the results described in this study should prove useful in the design of future balloon-expandable coronary stents.

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Section: Discussionmentioning

confidence: 92%

Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis

Martín¹,

Boyle²

2015

Cardiovasc Eng Tech

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“…The finite element models of the stents were generated and meshed in ANSYS (Canonsburg, PA, USA) and were generated based on the stents used in the ISAR STEREO Trial, namely the ACS RX MultiLink and the ACS MultiLink RX Duet [12]. Both stents are manufactured by the same company, namely Guidant/Advanced Cardiovascular Systems.…”

Section: Model Geometrymentioning

confidence: 99%

“…In recent years, several clinical trials have identified stent strut thickness as an independent predictor of restenosis [2,12,23]. A clear conclusion from the many clinical studies on stent strut thickness is that stents with thinner struts have a lower restenosis rate, consequently, most of the current generation of stents are produced with thinner struts using high strength materials such as cobalt-chromium alloys [20].…”

Section: Introductionmentioning

confidence: 99%

“…This may be achieved by investigating the mechanical cause of the difference in restenosis outcome for thinner and thicker strut stents using numerical modelling. The ISAR-STEREO clinical trial focussed on the influence of stent strut thickness and compared the restenosis outcome for two stents with the same design but different strut thickness [12]. In the study presented here, finite element models of these stents were developed and the stents were deployed in idealised stenosed vessels in order to compare the mechanical environment of the vessel for each stent.…”

Section: Introductionmentioning

confidence: 99%

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Determination of the influence of stent strut thickness using the finite element method: implications for vascular injury and in-stent restenosis

Zahedmanesh

Lally

2009

Med Biol Eng Comput

123

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Many clinical studies, including the ISAR-STEREO trial, have identified stent strut thickness as an independent predictor of in-stent restenosis where thinner struts result in lower restenosis than thicker struts. The aim of this study was to more conclusively identify the mechanical stimulus for in-stent restenosis using results from such clinical trials as the ISAR-STEREO trial. The mechanical environment in arteries stented with thin and thicker strut stents was investigated using numerical modelling techniques. Finite element models of the stents used in the ISAR-STEREO clinical trial were developed and the stents were deployed in idealised stenosed vessel geometries in order to compare the mechanical environment of the vessel for each stent. The stresses induced within the stented vessels by these stents were compared to determine the level of vascular injury caused to the artery by the stents with different strut thickness. The study found that when both stents were expanded to achieve the same initial maximum stent diameter that the thinner strut stent recoiled to a greater extent resulting in lower luminal gain but also lower stresses in the vessel wall, which is hypothesised to be responsible for the lower restenosis outcome. This study supports the hypothesis that arteries develop restenosis in response to injury, where high vessel stresses are a good measure of that injury. This study points to a critical stress level in arteries, above which an aggressive healing response leads to in-stent restenosis in stented vessels. Stents can be designed to reduce stresses in this range in arteries using preclinical tools such as numerical modelling.

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“…Os resultados obtidos após implante de stents são sobremaneira influenciados por sua configuração e arquitetura [3][4][5] , material utilizado para recobrir sua superfície 6 e espessura de suas hastes 5,7,8 . Ademais, comparações entre stents auto-expansíveis e balão-expansíveis têm demonstrado as vantagens da necessidade de menores pressões de insuflação dos primeiros, com taxas de reestenose angiográfica e clínica semelhantes entre os dois tipos de dispositivos, mas menor incidência de injúria e dissecção de bordos com os stents auto-expansíveis 9 .…”

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Exeqüibilidade, eficácia e segurança do sistema de stent CardioMindTM no tratamento de lesões em vasos de fino calibre: um estudo seriado com angiografia e ultra-som intracoronário

Chamié¹,

Costa²,

Abizaid³

et al. 2008

Rev. Bras. Cardiol. Invasiva

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RESUMOIntrodução: A intervenção coronária percutânea em vasos de fino calibre está associada a piores resultados imediatos e tardios, com elevadas taxas de reestenose, motivando o desenvolvimento de novos instrumentais para tal finalidade. Objetivo: Avaliar a exeqüibilidade, a eficácia e a segurança do novo sistema de stent CardioMind ™ para o tratamento de lesões em vasos de fino calibre. Método: Dez pacientes portadores de lesões únicas, de novo, < 14 mm, em artérias coronárias nativas < 2,5 mm de diâmetro foram submetidos a implante do stent CardioMind™. Todos os pacientes foram submetidos a angiografia e ultra-sonografia intracoronária (USIC) pós-procedimento e aos seis meses, com o desfecho primário de eficácia avaliado pela perda luminal tardia (PT) à angiografia e porcentagem (%) de obstrução do stent à USIC. Resultados: A média das idades foi de 63 ± 10,6 anos, 60% dos pacientes eram do sexo feminino e 60%, diabéticos. O diâmetro de referência do vaso e a extensão da lesão foram de 2,06 ± 0,27 mm e 9,35 ± 1,39 mm, respectivamente. Sucesso do dispositivo e do procedimento foi obtido em todos os pacientes. Aos seis meses, a PT foi de 0,53 ± 0,60 mm e o volume de obstrução do stent à USIC, de 24,1 ± 8,7%. Um paciente apresentou reestenose binária, necessitando nova revascularização. Não houve óbitos e/ou infarto do miocárdio no acompanhamento clínico de seis meses. Conclusões: Este estudo piloto, com a utilização pela primeira vez em humanos do sistema de stent CardioMind ™ em artérias coronárias de fino calibre, demonstrou ser esse stent factível e seguro, com resultados animadores na redução da hiperplasia intimal. O impacto clínico desses achados deve ser avaliado numa coorte maior de pacientes. DESCRITORES:Contenedores. Coronariopatia. Angioplastia transluminal percutânea coronária. Ultra-sonografia. SUMMARY Feasibility, Efficacy and Safety of the CardioMind ™ Stent System in the Treatment of Small Coronary Vessels: a Serial Angiography and Intravascular Ultrasound StudyBackground: Percutaneous coronary intervention in small vessels is associated to poor short and long-term results with high rates of restenosis, inducing the development of newer devices for this purpose. Objective: To assess the feasibility, efficacy and safety of the new CardioMind ™ stent system in the treatment of small vessel coronary artery disease (CAD). Methods: Ten patients presenting a single, de novo lesion in a native coronary artery < 2.5 mm in diameter were assigned to receive the CardioMind ™ stent. All patients were submitted to angiography and intravascular ultrasound (IVUS) evaluation immediately post-procedure and at 6 months. The primary end-point of efficacy was assessed by the late lumen loss at angiography and percentage (%) of neointimal obstruction at IVUS at 6 months. Results: Mean age was 63 ± 10.6 years, 60% were female and 60% diabetics. Reference vessel diameter and lesion length were 2.06 mm ± 0.27 mm and 9.35 mm ± 1.39 mm, respectively. Device and procedure success were obtained in all patients. At 6-month...

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Intracoronary Stenting and Angiographic Results

Abstract: The use of a thinner-strut device is associated with a significant reduction of angiographic and clinical restenosis after coronary artery stenting. These findings may have relevant implications for the currently most widely used percutaneous coronary intervention.

Cited by 723 publications

References 27 publications

Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis

Sequential Structural and Fluid Dynamics Analysis of Balloon-Expandable Coronary Stents: A Multivariable Statistical Analysis

Determination of the influence of stent strut thickness using the finite element method: implications for vascular injury and in-stent restenosis

Exeqüibilidade, eficácia e segurança do sistema de stent CardioMindTM no tratamento de lesões em vasos de fino calibre: um estudo seriado com angiografia e ultra-som intracoronário

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