Evaluation of Thrombogenicity of Fluoropassivated Polyester Patches following Carotid Endarterectomy

Pedrini, L; Dondi, Maurizio; Magagnoli, A; Magnoni, F.; Pisano, Emilio; Giudice, Eleonora Del; Santoro, María Carolina López

doi:10.1007/s100160010129

Cited by 16 publications

(10 citation statements)

References 13 publications

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“…In contrast, the fluoropolymers used in the EES are associated with less thrombogenicity and inflammation and reduced platelet activation (29,42). The greater biocompatibility and hemocompatibility of this class of polymers has led to their use in other vascular territories as well (43,44). Clinical implications.…”

Section: Discussionmentioning

confidence: 94%

Impact of the Everolimus-Eluting Stent on Stent Thrombosis

Baber

Mehran

Sharma

et al. 2011

Journal of the American College of Cardiology

260

109

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Section: Discussionmentioning

confidence: 94%

Impact of the Everolimus-Eluting Stent on Stent Thrombosis

Baber

Mehran

Sharma

et al. 2011

Journal of the American College of Cardiology

260

109

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“…Fluoropolymers have also demonstrated thromboresistant properties with faster endothelialization tendencies when used in devices directly in contact with blood in several in vitro and in vivo experiments. For example, a fluoropolymer‐coated polyester carotid patch was shown to be thromboresistent in preclinical studies and had less neointima in clinical settings compared to the polyester patch alone 33–35 . This unique combination of thromboresistance and faster healing properties led researchers to refer to this as “fluoropassivation.” 34,36 …”

Section: Stent Factorsmentioning

confidence: 99%

Low Stent Thrombosis Risk with the XIENCE V® Everolimus-Eluting Coronary Stent: Evidence from Randomized and Single-Arm Clinical Trials

Bezenek¹,

Hermiller²,

Lansky³

et al. 2011

Journal of Interventional Cardiology

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The XIENCE V® Everolimus-Eluting Coronary Stent System (EECSS) has been evaluated in multiple randomized controlled trials (RCTs) with several different comparators (SPIRIT FIRST, SPIRIT II, SPIRIT III, SPIRIT IV, COMPARE, ISAR-TEST 4, SORT-OUT IV, and RESOLUTE All-Comers RCT). The available results consistently demonstrated numerically low stent thrombosis (ST) rates in the XIENCE V arm treated patients. The use of XIENCE V in complex patients with diabetes, overlapping stents, multistenting, and other known risk factors has not significantly increased the occurrence of ST, as evident in the 2-year rates of both per protocol and Academic Research Consortium (ARC)-defined ST rates in the SPIRIT IV RCT, as well as the COMPARE real-world RCT. Furthermore, available long-term follow-up in the SPIRIT FIRST, SPIRIT II, and SPIRIT III RCTs showed continued numerically low very late ST rates as well. High compliance rates of dual antiplatelet therapy (DAPT) were observed in the SPIRIT trials, which may have contributed to consistently numerically low ST rates in the XIENCE V arm treated patients. Several potential risk factors for developing ST may well have been minimized through the selective XIENCE V thin strut design, biocompatible polymers, and antiproliferative drug usage. (J Interven Cardiol 2011;24:326-341).

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“…Such surfaces adsorb higher ratios of albumin to fibrinogen, resulting in significant reductions in platelet adhesion and activation 11,12 . Albumin adsorption passivates the fluorinated polymer surface, which contributes to thromboresistance, lack of complement activation, and the lower inflammation of fluorinated polymers in blood‐contact applications in animal and in human 13–16 . Fluorination of polymer surfaces also increases the rate of reendothelialization of the vessel wall in animal models 14 .…”

Section: Hemocompatibility and Biocompatibilitymentioning

confidence: 99%

“…A high ratio of albumin to fibrinogen in this layer has been shown to greatly improve biocompatibility and hemocompatibility. 7-10 A series of studies [11][12][13][14][15][16][17][18] have shown that fluorine-rich surfaces are nonthrombogenic and biocompatibile. Such surfaces adsorb higher ratios of albumin to fibrinogen, resulting in significant reductions in platelet adhesion and activation.…”

Section: Hemocompatibility and Biocompatibilitymentioning

confidence: 99%

“…11,12 Albumin adsorption passivates the fluorinated polymer surface, which contributes to thromboresistance, lack of complement activation, and the lower inflammation of fluorinated polymers in blood-contact applications in animal and in human. [13][14][15][16] Fluorination of polymer surfaces also increases the rate of reendothelialization of the vessel wall in animal models. 14 Due to their excellent hemocompatibility and biocompatibility, fluorinated polymers enjoy wide application in arterial prostheses, graft prostheses, drug-eluting leads of implantable cardioverter-defibrillators, hemodialysis membranes, vascular and neurovascular sutures, guidewire coatings, and in guiding catheters.…”

Section: Hemocompatibility and Biocompatibilitymentioning

confidence: 99%

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XIENCE V™ Stent Design and Rationale

Ding¹,

Pacetti²,

Tang³

et al. 2009

J Interven Cardiology

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Drug‐eluting stents (DES) are a preferred treatment modality for occlusive coronary artery disease. First‐generation DES have demonstrated high levels of efficacy. However, concerns have been raised over late thrombotic events. XIENCE V™ everolimus‐eluting coronary stent is a second‐generation DES designed to be more deliverable and safe, while maintaining efficacy in a broad patient population compared with first‐generation DES. 1 − 3 As a drug/device combination product, the overall performance of a DES is determined by its components and how well they are integrated. XIENCE V utilizes the MULTI‐LINK VISION® stent, the antiproliferative drug everolimus, a fluorinated polymer drug carrier, poly(vinylidene fluoride‐co‐hexafluoropropylene) (PVDF‐HFP), and a stent‐specific delivery system. A DES coating must fulfill the multiple goals of biocompatibility, controlled drug release and maintenance of the coating durability through stent crimping, and expansion in vivo. The XIENCE V coating utilizes a two‐layer coating system composed of an acrylate primer and a fluorinated copolymer drug reservoir. Fluorinated polymers have a long history of use in permanent vascular implant applications. The XIENCE V fluorinated copolymer offers in vivo biocompatibility combined with excellent chemical stability and high purity. Described in this article are the design rationale and polymer selection criteria. The hemocompatibility and biocompatibility of the fluorinated polymer coating are discussed. Characterization results on drug release control, possible drug release mechanism, coating integrity, coating uniformity, and fatigue resistance are also presented.

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Evaluation of Thrombogenicity of Fluoropassivated Polyester Patches following Carotid Endarterectomy

Cited by 16 publications

References 13 publications

Impact of the Everolimus-Eluting Stent on Stent Thrombosis

Impact of the Everolimus-Eluting Stent on Stent Thrombosis

Low Stent Thrombosis Risk with the XIENCE V® Everolimus-Eluting Coronary Stent: Evidence from Randomized and Single-Arm Clinical Trials

XIENCE V™ Stent Design and Rationale

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