Zotarolimus (ABT-578) eluting stents

Burke, Sandra E.; Kuntz, Richard E.; Schwartz, Lewis B.

doi:10.1016/j.addr.2006.01.021

Cited by 84 publications

(55 citation statements)

References 47 publications

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“…1,2 Zotarolimus has also been found to have in vivo chemical features that support its consideration as an alternative to paclitaxel for this particular application. 12,13 In vitro studies have demonstrated that zotarolimus displays a high octanol:water partition coefficient compared with other antiproliferative agents. 13 This property appears to enhance tissue uptake after delivery and facilitates its rapid crossing through cell membranes.…”

Section: Discussionmentioning

confidence: 99%

“…12,13 In vitro studies have demonstrated that zotarolimus displays a high octanol:water partition coefficient compared with other antiproliferative agents. 13 This property appears to enhance tissue uptake after delivery and facilitates its rapid crossing through cell membranes. There is recent evidence that suggests the biological efficacy of this delivery method.…”

Section: Discussionmentioning

confidence: 99%

“…1,2,9,10 Because of its pharmacological and biological profile, zotarolimus has also been proposed as an antiproliferative agent for this particular application. [12][13][14] The aim of the present study was to evaluate the pharmacokinetic profile, safety, and efficacy of a zotarolimus-coated balloon (ZCB) in the prevention of restenosis using a novel model of superficial femoral artery (SFA) stenosis in the familial hypercholesterolemic swine (FHS).…”

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confidence: 99%

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Vascular Response to Zotarolimus-Coated Balloons in Injured Superficial Femoral Arteries of the Familial Hypercholesterolemic Swine

Granada

Milewski

Zhao

et al. 2011

Circ: Cardiovascular Interventions

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Background-Drug-coated balloons are rapidly emerging as a therapeutic alternative for the interventional treatment of peripheral vascular disease. The purpose of this study was to test the hypothesis that an angioplasty balloon coated with the mTOR inhibitor zotarolimus (ZCB) would inhibit neointimal hyperplasia in a novel injury-based superficial femoral artery model in the familial hypercholesterolemic swine. Methods and Results-A total of 44 familial hypercholesterolemic swine were included (12 designated to study tissue pharmacokinetics and 32 to study safety and efficacy). Fogarty balloon denudation was performed in all superficial femoral artery segments, followed by balloon angioplasty. In the pharmacokinetic study, a total of 24 ZCBs (300 g/cm 2 ) were used. Zotarolimus was detected in arterial tissue at 5 minutes (162 ng/mg of tissue), 24 hours (5.9 ng/mg of tissue), and 28 days (0.007 ng/mg of tissue) after ZCB inflation. In the safety and efficacy study, superficial femoral artery segments were randomized to either high-dose (600 g/cm 2 , nϭ16), low-dose (300 g/cm 2 , nϭ16), or paired uncoated balloons (high-dose ZCB control, nϭ16; low-dose ZCB control, nϭ16). At 28 days, the percentage of angiographic stenosis was similar among all tested groups. Histological analysis demonstrated a reduction in neointimal formation in both ZCB groups compared with controls (high-dose ZCB 44% reduction, Pϭ0.007; low-dose ZCB 22% reduction, Pϭ0.08). There was no evidence of delayed arterial healing or vascular toxicity in any of the ZCB groups. Conclusions-The single delivery of zotarolimus via coated balloon is feasible, and therapeutic levels are maintained up to 28 days. The ZCB technology appears to be effective in the reduction of neointimal proliferation in the superficial femoral artery of the familial hypercholesterolemic swine. (Circ Cardiovasc Interv. 2011;4:447-455.)

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Vascular Response to Zotarolimus-Coated Balloons in Injured Superficial Femoral Arteries of the Familial Hypercholesterolemic Swine

Granada

Milewski

Zhao

et al. 2011

Circ: Cardiovascular Interventions

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“…The substrate is a Co-Cr alloy with good properties in mechanics and radiopacity. The drug-polymer coating is a formation of zotarolimus and persistent anti-fouling phospholipids co-polymer, which constructs an anti-thrombogenic and anti-restenosis surface [30]. Xience V TM also adopts the Co-Cr platform.…”

Section: Drug Eluting Stentsmentioning

confidence: 99%

Current status of research and application in vascular stents

Yang

Maitz

2013

Chin. Sci. Bull.

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Cardiovascular diseases have been the leading cause of death in modern society. Using vascular stents to treat these coronary and peripheral artery diseases has been one of the most effective and rapidly adopted medical interventions. During the twenty-five years' development of vascular stents, revolutionary cardiovascular stents like drug eluting stents and endothelial progenitor cells capture stents have emerged. In this review, the evolution of vascular stents is summarized, aiming to provide a glimpse into the future of vascular stents. Advanced designs, focusing on the investigations of new substrates, new platforms, new drugs and new biomolecules are currently under evaluation with promising clinical studies. The concept of "time sequence functional stent" has been raised in this paper. It presents anti-proliferative properties in the first phase after implantation and subsequently support endothelialization. It also shows long-term inertness without release of toxic ions or toxic degradation products. The success of this concept is briefly presented with a clinical study in this model stents.

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“…The zotarolimus elution is designed to inhibit proliferation of smooth muscle cells; the phosphorylcholine-based polymer coating is designed to simulate red blood cells, thus mimicking the natural cell membrane 6 . These features are designed to reduce the typical biological response to an implanted device and enhance long-term safety.…”

Section: Device Descriptionmentioning

confidence: 99%