Long-Term Clinical Follow-up of Sirolimus-Eluting (CYPHER™) Coronary Stents in the Treatment of InStent Restenosis in an Unselected Population

Ruchin, Peter; Muller, D.; Faddy, Steven; Baron, D.; Roy, Probal; Wilson, Stephanie H.

doi:10.1016/j.hlc.2007.02.090

Cited by 7 publications

(7 citation statements)

References 23 publications

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“…In less than 3 years, more than 90% of cardiovascular stenting procedures in the United States adopted the new technology 2. However, in the past 3 years several safety and clinical issues regarding DES were both raised by the FDA and reported in published research 3–14. Therefore, use of drug‐coated stents in the United States dropped significantly compared to bare metal stents.…”

Section: Introductionmentioning

confidence: 99%

“…Despite the ongoing controversy among physicians, published data indicate that DES may be associated with several adverse clinical effects, such as late state thrombosis and even death 3–14. These clinical effects were attributed to factors like drug type and polymeric carrier.…”

Section: Introductionmentioning

confidence: 99%

“…Recent publications reported DES coating defects, including delaminating, cracking, and peeling in a variety of commercially available stents. As a result, questions have been raised as to whether these defects are related to safety issues 3–14. In biometrical perspective, any coating, including polymeric coating of DES, is considered foreign to the body and may trigger adverse effects.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of drug‐eluting stents' coating durability—Clinical and regulatory implications

et al. 2009

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Drug-eluting stents (DES) revolutionized cardiovascular treatment by virtually eliminating in-stent restanosis. However, in the past 3 years the U.S. Food and Drug Administration and published studies have raised several safety issues regarding DES such as late state thrombosis and increased mortality. Recent publications have described DES coating delaminating, cracking, and peeling in commercially available stents. It has been suggested that these properties are responsible for the deleterious effects. The goal of this work is to describe a quantitative in vitro durability tests for DES, referred to as Quantified Defects (QD). The technique was implemented on various stent polymer-coated models to determine its ability to differentiate between coating properties. Stents' coating defects were tested using light microscopy, scanning electron microscopy, and a micro-balance. High-performance liquid chromatography was used for measuring drug release. Stents were incubated at either 37 or 60 degrees C and sampled at 0, 3, and 30 days. Stent coating durability was tested using stainless steel control stents versus stents having increased surface adhesion, both of which were then coated with conventional spray-coating methods. Drug-coated stents tested for defects demonstrated a deteriorating durability profile as reflected by QD indices. Different coating models showed unique QD indices that reflected their superior or inferior coating durability. These results indicated that the methodology was able to differentiate between different models. In conclusion, this simple low-cost testing methodology can be easily used during DES development, with either durable or biodegradable polymers.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Evaluation of drug‐eluting stents' coating durability—Clinical and regulatory implications

et al. 2009

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“…In the last 3 years, however, the U.S. Food and Drug Administration, along with a variety of studies, raised several safety and clinical issues, for example, late stage thrombosis, with regard to DES. [8][9][10][11][12][13][14][15][16][17][18][19] Recent publications demonstrated DES coating defects in a variety of commercially available stents. 13 Accordingly, researchers have questioned the relation between published safety issues and coating defects.…”

Section: Introductionmentioning

confidence: 99%

Drug‐eluting stent with improved durability and controllability properties, obtained via electrocoated adhesive promotion layer

et al. 2009

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Drug-eluting stents (DES) have become an accepted technology in intravascular intervention. Manufacturing methodologies of DES are based mainly on mechanical processes, which tend to generate coatings that have poor stability properties; these were recently related as a potential hazard. A novel approach for significantly increasing the adhesion of polymer coatings onto DES is presented. The method is based on the electrochemistry of diazonium salts. These substances are organic compounds with the characteristic structure of R-N(2) (+) X(-), where R is an organic residue and X(-) is an anion. The objective of this article is to study the properties of a selected diazonium salt 4-(1-dodecyloxy)-phenyldiazonium tetrafluoroborate, referred as C(12)-phenyldiazonium. This material was found to be a superior adhesive promoter for polymeric coatings applied onto metallic stents. C(12)-phenyldiazonium was synthesized and electrocoated on metallic stents and plates. The multilayer films of C(12)-phenyldiazonium were further characterized through electrochemical (cyclic voltammetry, impedance spectroscopy), physical (light and scanning electron microscopy, X-ray photoelectron spectroscopy, peeling tests), and chemical methodology (high pressure liquid chromatography). Further biocompatibility properties of the electrocoated basecoat were evaluated using in vitro and in vivo models. Synthesized C(12)-phenyldiazonium was successfully electrocoated onto metallic surfaces. Electrochemical tests demonstrated its efficient and controllable electrocoating. C(12)-phenyldiazonium was found to increase polymeric coating stability as was reflected by a standard adhesion test. Electrocoated metallic stents spray-coated with a second polymeric film showed improved durability following incubation in physiological buffer. Furthermore, this improvement in durability exhibits stabilized drug release. In addition, biocompatibility evaluations have demonstrated basecoat's inert properties.

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“…Ruchin et al18 conducted a long term follow‐up for an unselected population of patients, who were treated for in stent restenosis, after implantation of a bare metal stent, with the Cypher™ sirolimus eluting stent. Despite the limitations of the study, the results showed clearly a high efficacy of sirolimus eluting stents, pointing at a promising application of the Cypher™ stents for treatment of in stent restenosis following the implantation of bare metal stents.…”

Section: Drugsmentioning

confidence: 99%

Pharmaceutical aspects of drug eluting stents

Deconinck

Sohier²,

Scheerder³

et al. 2008

Journal of Pharmaceutical Sciences

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Long-Term Clinical Follow-up of Sirolimus-Eluting (CYPHER™) Coronary Stents in the Treatment of InStent Restenosis in an Unselected Population

Cited by 7 publications

References 23 publications

Evaluation of drug‐eluting stents' coating durability—Clinical and regulatory implications

Evaluation of drug‐eluting stents' coating durability—Clinical and regulatory implications

Drug‐eluting stent with improved durability and controllability properties, obtained via electrocoated adhesive promotion layer

Pharmaceutical aspects of drug eluting stents

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