Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating

Hausleiter, Jörg; Kastrati, Adnan; Wessely, Rainer; Dibra, Alban; Mehilli, Julinda; Schratzenstaller, Thomas; Graf, Isolde; Renke-Gluszko, Magdalena; Behnisch, Boris; Dirschinger, Josef; Wintermantel, E.; Schömig, Albert

doi:10.1093/eurheartj/ehi405

Cited by 106 publications

(62 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The eventual Paclitaxel release is attributed to a combination of polymer erosion and drug diffusion. The Traslumina stent contains no polymers for CR of the drug, but rather the metallic stent surface itself is microporous to accommodate the drug using onsite coating technology (Hausleiter et al, 2005). The high partition coefficient of the lipophilic drug allows long term retention and a biological outcome which indicates that dose-dependent efficacy in restenosis prevention is achievable with this new DES concept.…”

Section: Various Approaches For Drug Delivery From Stentsmentioning

confidence: 99%

Mechanism of controlled release kinetics from medical devices

Raval

Parikh

2010

Braz. J. Chem. Eng.

View full text Add to dashboard Cite

-Utilization of biodegradable polymers for controlled drug delivery has gained immense attention in the pharmaceutical and medical device industry to administer various drugs, proteins and other biomolecules both systematically and locally to cure several diseases. The efficacy and toxicity of this local therapeutics depends upon drug release kinetics, which will further decide drug deposition, distribution, and retention at the target site. Drug Eluting Stent (DES) presently possesses clinical importance as an alternative to Coronary Artery Bypass Grafting due to the ease of the procedure and comparable safety and efficacy. Many models have been developed to describe the drug delivery from polymeric carriers based on the different mechanisms which control the release phenomenon from DES. Advanced characterization techniques facilitate an understanding of the complexities behind design and related drug release behavior of drug eluting stents, which aids in the development of improved future drug eluting systems. This review discusses different drug release mechanisms, engineering principles, mathematical models and current trends that are proposed for drug-polymer coated medical devices such as cardiovascular stents and different analytical methods currently utilized to probe diverse characteristics of drug eluting devices.

show abstract

Section: Various Approaches For Drug Delivery From Stentsmentioning

confidence: 99%

Mechanism of controlled release kinetics from medical devices

Raval

Parikh

2010

Braz. J. Chem. Eng.

View full text Add to dashboard Cite

show abstract

“…11 More recently, in a clinical study in which the efficacy of several doses of rapamycin was assessed, we showed that a nonpolymer coating with rapamycin is safe and leads to a dose-dependent reduction in restenosis. 12 Although the advantage derived from the lack of a polymer coating in on-site-coated, rapamycin-eluting stents is readily understandable, their relative efficacy compared with commercially available polymer-based, DESs has yet to be evaluated.…”

Section: Clinical Perspective P 279mentioning

confidence: 99%

“…11,13 The 2% rapamycin solution used for the stent coating in this study was selected on the basis of results from a dose-finding study in which the antirestenotic effectiveness of various concentrations of rapamycin solution was evaluated. 12 Paclitaxel-eluting stents were available in diameters of 2.25, 2.5, 2.75, 3.0, and 3.5 mm and in lengths of 8,12,16,20,24,28, and 32 mm. Rapamycin stents were available in diameters of 2.0, 2.5, 3.0, and 3.5 mm and in lengths of 8,12,16,18,23, and 25 mm.…”

Section: Study Population and Protocolmentioning

confidence: 99%

“…12 Paclitaxel-eluting stents were available in diameters of 2.25, 2.5, 2.75, 3.0, and 3.5 mm and in lengths of 8,12,16,20,24,28, and 32 mm. Rapamycin stents were available in diameters of 2.0, 2.5, 3.0, and 3.5 mm and in lengths of 8,12,16,18,23, and 25 mm. Stenting in multiple lesions and the use of Ͼ1 stent per lesion were allowed under the condition that the same randomly assigned stent had to be implanted in all lesions.…”

Section: Study Population and Protocolmentioning

confidence: 99%

See 1 more Smart Citation

Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Reduction of Late Lumen Loss

et al. 2006

Self Cite

View full text Add to dashboard Cite

MD; for the Intracoronary Stenting and Angiographic Restenosis-Test Equivalence Between 2 Drug-Eluting Stents (ISAR-TEST) Trial InvestigatorsBackground-Although drug-eluting stents (DESs) constitute a major achievement in preventing restenosis, concerns remain regarding the increased inflammatory and thrombogenic responses associated with the polymers used. Recently, we showed that a nonpolymer on-site coating with rapamycin not only is feasible and safe but also leads to a dose-dependent reduction in restenosis. Methods and Results-To assess whether polymer-free stents coated on-site with 2% rapamycin solution are inferior to polymer-based paclitaxel-eluting stents for the prevention of restenosis, we randomly assigned a total of 450 patients with de novo lesions in native coronary vessels, excluding the left main trunk, to either the polymer-free, rapamycin-coated Yukon DES (rapamycin stent) or the polymer-based, paclitaxel-eluting Taxus stent (paclitaxel stent). The primary end point was in-stent late lumen loss. Secondary end points were angiographic restenosis and target lesion revascularization. The study was designed to test the noninferiority of the rapamycin stent compared with the paclitaxel stent with respect to late lumen loss according to a noninferiority margin of 0.13 mm. Follow-up angiography was completed in 81% of the patients. The mean difference in in-stent late lumen loss between the rapamycin-stent group and the paclitaxel-stent group was 0.002 mm, and the upper limit of the 1-sided 95% confidence interval was 0.10 mm (Pϭ0.02 from test for noninferiority). No significant differences were observed regarding angiographic restenosis rates (14.2% with the rapamycin stent and 15.5% with the paclitaxel stent) and target lesion revascularization rates due to restenosis (9.3% in both groups). Conclusions-The polymer-free, rapamycin-coated stent has an antirestenotic effect that is not inferior to that observed with the polymer-based paclitaxel-eluting stent.

show abstract

“…Such stents can be spray coated with selected drugs that are absorbed onto surface micropores 26,27 to allow homogeneous drug transfer. 28 An alternative polymer-free technology comprises selective microstructuring of the abluminal surface of the stainless steel stent through controlled microabrasion processes.…”

Section: Microporous and Microstructured Surfacesmentioning

confidence: 99%