Preclinical evaluation of a novel polyphosphazene surface modified stent

Koppara, Tobias; Sakakura, Kenichi; Pacheco, Erica; Cheng, Qi; Zhao, Xiaoqing; Acampado, Eduardo; Finn, Aloke V.; Barakat, Mark; Maillard, Luc; Ren, Jane; Deshpande, Mahesh C.; Kolodgie, Frank D.; Joner, Michael; Virmani, Renu

doi:10.1016/j.ijcard.2016.07.181

Cited by 27 publications

(32 citation statements)

References 39 publications

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“…The PVDF‐HFP “fluoropolymer” used on CoCr‐EESs adsorbs and retains albumin compared with BMSs, and this is thought to help minimize platelet adhesion and activation and leukocyte recruitment . In a preclinical study, other fluoropolymer‐coated metallic stents, in the absence of antiproliferative drugs, showed significantly less inflammation and less neointima than BMSs at 28 and 90 days in the coronary arteries of pigs . In a porcine shunt model from the same study, thrombogenicity and inflammatory cell adherence were also less with fluoropolymer‐coated stents than with BMSs .…”

Section: Discussionmentioning

confidence: 99%

“…14 In a preclinical study, other fluoropolymer-coated metallic stents, in the absence of antiproliferative drugs, showed significantly less inflammation and less neointima than BMSs at 28 and 90 days in the coronary arteries of pigs. 15 In a porcine shunt model from the same study, thrombogenicity and inflammatory cell adherence were also less with fluoropolymer-coated stents than with BMSs. 15 In another study, CoCr-EESs showed the least thrombogenicity and cell adhesion compared with 4 types of current BP-DESs in the porcine shunt model.…”

Section: Inflammatory Reactionmentioning

confidence: 91%

“…15 In a porcine shunt model from the same study, thrombogenicity and inflammatory cell adherence were also less with fluoropolymer-coated stents than with BMSs. 15 In another study, CoCr-EESs showed the least thrombogenicity and cell adhesion compared with 4 types of current BP-DESs in the porcine shunt model. 16 Metals themselves, such as those used in CoCr-EESs, can also provoke inflammation.…”

Section: Inflammatory Reactionmentioning

confidence: 91%

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Very Late Pathological Responses to Cobalt–Chromium Everolimus‐Eluting, Stainless Steel Sirolimus‐Eluting, and Cobalt–Chromium Bare Metal Stents in Humans

Mori

Atmakuri

Torii

et al. 2017

JAHA

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BackgroundThe “very late” clinical outcomes for durable polymer drug‐eluting stents and bare metal stents (BMSs) have been shown to be dissimilar in clinical studies. Conceptually, the long‐term vascular compatibility of BMSs is still regarded to be superior to drug‐eluting stents; however, no pathologic study to date has specifically addressed this issue. We evaluated the very late (≥1 year) pathologic responses to durable polymer drug‐eluting stents (cobalt–chromium [CoCr] everolimus‐eluting stents [EESs] and stainless steel sirolimus‐eluting stents [SS‐SESs]) versus BMSs (CoCr‐BMSs).Methods and ResultsFrom the CVPath stent registry, we studied a total of 119 lesions (40 CoCr‐EESs, 44 SS‐SESs, 35 CoCr‐BMSs) from 92 autopsy cases with a duration ranging from 1 to 5 years. Sections of stented coronary segments were pathologically analyzed. Inflammation score and the percentage of struts with giant cells were lowest in CoCr‐EESs (median inflammation score: 0.6; median percentage of struts with giant cells: 3.8%) followed by CoCr‐BMSs (median inflammation score: 1.3 [P<0.01]; median percentage of struts with giant cells: 8.9% [P=0.02]) and SS‐SESs (median inflammation score: 1.7 [P<0.01]; median percentage of struts with giant cells: 15.3% [P<0.01]). Polymer delamination was observed exclusively in SS‐SESs and was associated with increased inflammatory and giant cell reactions. The prevalence of neoatherosclerosis with CoCr‐EESs (50%) was significantly less than with SS‐SESs (77%, P=0.02) but significantly greater than with CoCr‐BMSs (20%, P<0.01).ConclusionsCoCr‐EESs, SS‐SESs, and BMSs each demonstrated distinct vascular responses. CoCr‐EESs demonstrated the least inflammation, near‐equivalent healing to BMSs, and lower neointimal formation. These results challenge the belief that BMSs have superior biocompatibility compared with some polymeric coated drug‐eluting stents and may have implications for future stent design.

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Section: Discussionmentioning

confidence: 99%

Section: Inflammatory Reactionmentioning

confidence: 91%

Section: Inflammatory Reactionmentioning

confidence: 91%

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Very Late Pathological Responses to Cobalt–Chromium Everolimus‐Eluting, Stainless Steel Sirolimus‐Eluting, and Cobalt–Chromium Bare Metal Stents in Humans

Mori

Atmakuri

Torii

et al. 2017

JAHA

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“…In a porcine coronary artery stent implantation model versus a Vision bare metal stent (24 animals), the neointimal growth for COBRA PzF NCS System was significantly lower than for a Vision BMS [35]. At 28 and 90 days, the neointimal thickness for COBRA PzF NCS System was 0.16 and 0.1 mm versus Vision BMS 0.33 and 0.22 respectively (Fig.…”

Section: Gold Controlmentioning

confidence: 92%

“…In the SEM picture as well as the stained stent via light microscopy, very low amount of thrombotic mass can be seen in the COBRA PzF compared with significant mass on the Vision BMS ( Fig. 2c) [35].…”

Section: Gold Controlmentioning

confidence: 97%

Translational Research and Early Favorable Clinical Results of a Novel Polyphosphazene (Polyzene-F) Nanocoating

Bates

Yousaf

Lee³

et al. 2019

Regen. Eng. Transl. Med.

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This manuscript is a review of the preclinical and early clinical findings related to a unique fluorinated polyphosphazene nanolayer device surface modification. Polyzene-F (PzF) is a novel, high-molecular weight, highly pure polyphosphazene that was designed to enhance the biologic interface between a medical device surface and human tissue or blood. The polymer also has unique mechanical properties that for the first time allow implants to be paved with a coating that has a nanoscale thickness of < 50 nm. The coating has inherent thrombus resistant properties and takes on biomimetic properties soon after implant due to favorable protein adhesion. Over the last 1.5 decades, PzF has undergone extensive preclinical testing including benchtop endothelial cell migration and platelet adhesion studies followed by increasingly sophisticated evaluation in 16 different animal models. The coating consistently has shown reduced platelet adhesion, decreased clotting, reduced inflammation, and accelerated healing compared with different surfaces as well as uncoated controls. These preclinical findings have translated into early compelling clinical evidence that suggest enhanced healing and reduced thrombosis can be achieved with a PzF-coated implant. There are now two PzF nanocoated products approved by the US Food and Drug Association (FDA), embolic spheres, and a coronary stent. This is the first detailed overview of the history, preclinical findings, and current clinical results attributed to the PzF coating with emphasis on the coronary stent Cobra-PzF. Lay Summary Over the last few decades, we have seen remarkable advances in medical technology including the development of less invasive surgical alternatives for the treatment of heart and vascular disease. One of the key advances in treating or preventing heart attack, stroke, and limb loss has been the development of stents. Stents are small, metallic, mesh-like devices that can be expanded within blocked vessels via small catheters placed through the groin or wrist. These stents provide structural support while the vessel heals. One of the challenges with stents and other permanent device implants is related to how our bodies react to foreign

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Endovascular Metal Devices for the Treatment of Cerebrovascular Diseases

Zhang

et al. 2018

Advanced Materials

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Cerebrovascular disease involves various medical disorders that obstruct brain blood vessels or deteriorate cerebral circulation, resulting in ischemic or hemorrhagic stroke. Platinum coils with or without biological modification have become routine embolization devices in the cerebral aneurysm sac to reduce the risk of bleeding. Many intracranial stents, flow diverters and stent retrievers have been invented with uniquely designed structures. To accelerate the translation of these devices into clinical usage, an indepth understanding of the mechanical and material performance of these metal-based devices is critical. However, considering the more distal location and tortuous anatomic characteristics of cerebral arteries, present devices still risk failing to arrive at target lesions. Consequently, more flexible endovascular devices and novel designs are under urgent demand to overcome the deficiencies of existing devices. Herein, we discuss the pros and cons of the current structural designs when these devices are applied to the treatment of diseases ranging broadly from hemorrhages to ischemic strokes, in order to encourage further development of such kind of devices and investigation of their use in the clinic. Moreover, novel biodegradable materials and drug elution techniques, and the design, safety and efficacy of personalized devices for further clinical applications in cerebral vasculature are discussed.

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Preclinical evaluation of a novel polyphosphazene surface modified stent

Cited by 27 publications

References 39 publications

Very Late Pathological Responses to Cobalt–Chromium Everolimus‐Eluting, Stainless Steel Sirolimus‐Eluting, and Cobalt–Chromium Bare Metal Stents in Humans

Very Late Pathological Responses to Cobalt–Chromium Everolimus‐Eluting, Stainless Steel Sirolimus‐Eluting, and Cobalt–Chromium Bare Metal Stents in Humans

Translational Research and Early Favorable Clinical Results of a Novel Polyphosphazene (Polyzene-F) Nanocoating

Endovascular Metal Devices for the Treatment of Cerebrovascular Diseases

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