A third generation ultra-thin strut cobalt chromium stent: histopathological evaluation in porcine coronary arteries

Jabara, Refat; Geva, Sarah; Ribeiro, Henrique Barbosa; Chen, Jack P.; Hou, Dongming; Li, Jinsheng; King, Spencer B.; Chronos, Nicolas; Robinson, Keith A.

doi:10.4244/eijv5i5a99

Cited by 18 publications

(29 citation statements)

References 33 publications

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“…Impact of PES Platform Taxus Express PES, the frequency of uncovered struts was comparable between the 2 stents. Given that uncovered struts increase the possible risk of future thrombotic events, 24 the present results suggest that the modification of the stent platform of the Taxus Liberté PES successfully achieved significant reduction of neointima proliferation without sacrificing safety in patients treated with PES. Although detailed mechanisms are still unclear, we speculate that this might stem from the homogenous drug elution produced by the newly designed platform of the Taxus Liberté PES.…”

Section: Discussionmentioning

confidence: 88%

“…Farb et al have demonstrated that incomplete healing, consisting of persistent intimal fibrin deposition, intraintimal hemorrhage, and increased intimal and adventitial inflammation, was observed only in rabbit iliac lesions treated with higher-dose PES (42.0 mg and 20.2 mg). 24 Considering the local toxicity secondary to paclitaxel overdose, homogenous drug distribution afforded by the new platform might have more important implications for clinical practice. A largescale randomized study is required to test our hypothesis.…”

Section: Discussionmentioning

confidence: 99%

“…Based on a previous experimental study, this unique design delivers paclitaxel more evenly than the Taxus Express PES. 23 The use of thinner stent struts is also advantageous for decreasing the amount of local injury, 24 providing greater flexibility, and for improved deliverability. Despite these potential advantages, the impact of these modifications on neointima growth has not been sufficiently evaluated in humans.…”

Section: Discussionmentioning

confidence: 99%

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Impact of Stent Platform of Paclitaxel-Eluting Stents

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Circ J

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Circulation Journal Official Journal of the Japanese Circulation Society http://www. j-circ.or.jp ince the concept of stenting was first proposed more than 30 years ago, 1 a variety of factors, such as stent design, 2-4 strut thickness, 5,6 and material, 7 have been demonstrated to affect neointimal proliferation after bare-metal stent (BMS) implantation. Among these factors, because inhomogeneous strut placement of drug-eluting stents (DES) dramatically affects local drug concentrations, 8 stent design is one of the most important factors in the safety and efficacy of DES, by influencing uniform vessel healing and homogenous suppression of neointimal proliferation. Also, thinner stent struts reduce the incidence of BMS restenosis, regardless of differences in stent design. 6,9 No clinical report, however, has clearly demonstrated the relationship between stent design, strut thickness, and detailed arterial response after DES therapy, probably due the lack of established methods to quantitatively evaluate in vivo variability of neointima distribution in a multidimensional fashion.The Taxus Express TM paclitaxel-eluting stent (Taxus Express PES; Boston Scientific, Natick, MA, USA) and Taxus Liberté TM PES (Taxus Liberte PES; Boston Scientific) have identical drugs, drug doses, and polymers, but different stent platforms. The Taxus Liberte PES platform has thinner struts (0.038 in vs. 0.052 in; 0.097 mm vs. 0.13 mm) specifically designed for achieving uniform drug elution (Figure 1). Given that the only differences between the Taxus Express PES and Taxus Liberté PES are the stent design and strut thickness, we hypothesized that we could clarify the impact of these factors on vessel reaction in the early phase after DES therapy by comparing 6- The Taxus Express TM paclitaxel-eluting stent (Express-PES) and Taxus Liberté TM PES (Liberté-PES) have identical drugs, drug doses, and polymers, but different stent platforms. The Liberté-PES platform has thinner struts, specifically designed for more uniform drug elution.

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confidence: 88%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Impact of Stent Platform of Paclitaxel-Eluting Stents

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“…20 Contudo, outro trabalho também em porcos avaliando duas plataformas de cromo-cobalto com espessuras diferentes detectou pequena diminuição de reestenose com um stent de cromo-cobalto com haste ultrafina. 6 Todavia, outras características desse stent, como plataforma com geometria fixa, tamanho das células uniforme e acabamento superior da superfície (eliminação das impurezas retidas na superfície), também poderiam explicar os resultados, a despeito da espessura do stent. 6 Nesse sentido, há na literatura atual uma escassez de estudos comparando esses novos dispositivos no mundo real.…”

Section: Discussionunclassified

“…6 Todavia, outras características desse stent, como plataforma com geometria fixa, tamanho das células uniforme e acabamento superior da superfície (eliminação das impurezas retidas na superfície), também poderiam explicar os resultados, a despeito da espessura do stent. 6 Nesse sentido, há na literatura atual uma escassez de estudos comparando esses novos dispositivos no mundo real. Nossos resultados corroboram a utilização dos stents independentemente da liga, já que ambos apresentaram ótimo perfil de segurança e resultados clínicos semelhantes.…”

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Stents convencionais de aço inoxidável vs. cromo-cobalto: impacto clínico da liga metálica no cenário atual - registro InCor

Ribeiro¹,

Campos²,

Lopes³

et al. 2011

Rev. Bras. Cardiol. Invasiva

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Stainless Steel versus Cobalt-Chromium Bare Metal Stents: Clinical Impact of the Metal Alloy in a "Real World" ScenarioInCor RegistryBackground: Years ago studies demonstrated that the use of cobalt-chromium stents with thinner struts significantly reduced coronary restenosis when compared to conventional stainless steel stents available at the time. Since then, stents with struts < 100 µm and different metal alloys are available for clinical use. The objective of this study was to assess differences in the clinical outcomes of patients undergoing percutaneous coronary intervention (PCI) with thin strut stents and different metal alloys. Methods: Single center registry comparing the results of patients undergoing PCI with stainless steel stents (n = 135) vs. cobalt-chromium bare metal stents (n = 181). The primary endpoint was the occurrence of major adverse cardiac events (MACE), defined by death, acute myocardial infarction (AMI) or target vessel revascularization (TVR) in the late follow-up. Results: Mean patient age was 64 ± 11 years, 32.6% were diabetic and 65.5% had acute coronary syndrome at admission, with no differences for most of the clinical and angiographic characteristics assessed between groups. The use of direct stenting was more frequent in the cobalt-chromium group (30.3% vs. 40.2%; P = 0.04). After a median of 500 days of follow up, there was no statistically significant difference between groups for the occurrence of MACE (15.5% vs. 16.5%; P = 0.6), death (4.6% vs. 6.8%; P = 0.29), AMI (2.7% vs. 4.1%; P = 0.41) or TVR (10.4% vs. 10.1%; P = 0.97). Conclusions: In this real world population, cobaltchromium stents had similar efficacy and safety when compared to stainless steel stents, but with less coronary instrumentation.

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Still room for improvement: Preclinical and bench testing of a thin‐strut cobalt–chromium bare‐metal stent with passive coating

Wittchow

Hartwig

2016

J Biomed Mater Res

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There is a renewed interest in bare-metal stent (BMS) design as degradable polymer coatings are increasingly used as drug-delivery vehicles in drug-eluting stents (DESs), leaving it to the BMS platform to determine the long-term outcome of DES treatment. In this study comprising preclinical and bench tests, we compare two modern thin-strut BMSs of different design. Angiography, morphometry, and histopathology data were acquired in a porcine coronary artery model in a 28-day single-stent study (13 hybrid farm pigs) and in a 90-day overlapping-stent study (8 Yucatan mini-pigs). Standardized bench tests including ion release test were performed to compare mechanical performance of the two stent systems. We found that the optimized stent group induced significantly less neointimal formation and less inflammation than Multi-Link Vision in both (single stent and overlapping stent) porcine studies. The higher efficacy was also associated with a markedly reduced release of cobalt, nickel, chromium, and tungsten ions in physiological solution and better performance in mechanical delivery tests. In conclusion, a further increase in efficacy and better safety profile than the well-known Multi-Link Vision BMS can be achieved by careful optimization of the BMS backbone. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 1612-1621, 2017.

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A third generation ultra-thin strut cobalt chromium stent: histopathological evaluation in porcine coronary arteries

Cited by 18 publications

References 33 publications

Impact of Stent Platform of Paclitaxel-Eluting Stents

Impact of Stent Platform of Paclitaxel-Eluting Stents

Stents convencionais de aço inoxidável vs. cromo-cobalto: impacto clínico da liga metálica no cenário atual - registro InCor

Still room for improvement: Preclinical and bench testing of a thin‐strut cobalt–chromium bare‐metal stent with passive coating

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