Dose Response to Paclitaxel-Coated Balloon Catheters in the Porcine Coronary Overstretch and Stent Implantation Model

Kelsch, Bettina; Scheller, Bruno; Biedermann, Melanie; Clever, Yvonne P.; Schaffner, Silvio; Mahnkopf, Dirk; Speck, Ulrich; Cremers, Bodo

doi:10.1097/rli.0b013e31820577df

Cited by 117 publications

(93 citation statements)

References 24 publications

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“…Drug wash off rates of non-crosslinked PVP coatings, of which use was simulated for comparison, were with 48% and 95% during immersion and simulated use, respectively (Figures 4 and 6), considerably higher. Interestingly, observed PTX wash off rates of photochemically crosslinked PVP-coatings are in the same range as above-mentioned PTX losses of 26%-42% reported in literature for balloons coated with urea or iopromide, respectively, during in vitro passage through a hemostatic valve and a guiding catheter [11,12]. Comparison to literature values should however be handled with care, as different in vitro models are involved.…”

Section: Simulated Use Of Pvp-coated Dcbsupporting

confidence: 72%

“…Therefore, drug wash off rates during transit of the device through the vascular system should not be underestimated. For instance, while Kelsch et al [11] reported percental PTX wash off rates of up to 26% and 36% for urea-or iopromide-based DCB, respectively, Berg et al [12] observed a drug wash off rates of 42% for an iopromide-based formulation, both during in vitro passage through a hemostatic valve and a guiding catheter.…”

Section: Introductionmentioning

confidence: 99%

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Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Petersen¹,

Minrath²,

Kaule³

et al. 2013

Coatings

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Polyvinylpyrrolidone (PVP) is a conventionally applied hydrophilic lubricious coating on catheter-based cardiovascular devices, used in order to ease movement through the vasculature. Its use as drug reservoir and transfer agent on drug-coated balloons (DCB) is therefore extremely promising with regard to the simplification of its approval as a medical device. Here, we developed a PVP-based coating for DCB, containing paclitaxel (PTX) as a model drug, and studied the impact of crosslinking via UV radiation on drug stability, wash off, and transfer during simulated use in an in vitro vessel model. We showed that crosslinking was essential for coating stability and needed to be performed prior to PTX incorporation due to decreased drug bioavailability as a result of photodecomposition and/or involvement in vinylic polymerization with PVP under UV radiation. Moreover, the crosslinking time needed to be carefully controlled. While short radiation times did not provide enough coating stability, associated with high wash off rates during DCB insertion, long radiation times lowered drug transfer efficiency upon balloon expansion. A ten minutes radiation of PVP, however, combined a minimized drug wash off rate of 34% with an OPEN ACCESSCoatings 2013, 3 254 efficient drug transfer of 49%, underlining the high potential of photochemically crosslinked PVP as a coating matrix for DCB.

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Section: Simulated Use Of Pvp-coated Dcbsupporting

confidence: 72%

Section: Introductionmentioning

confidence: 99%

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Petersen¹,

Minrath²,

Kaule³

et al. 2013

Coatings

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“…All published pharmacokinetic data presented to date has been derived from computational models or experimental studies using normal vessels 11, 12, 13, 14. PCB showed a uniform drug distribution on a non‐stented vessel surface 15.…”

Section: Discussionmentioning

confidence: 99%

Biological effect on drug distribution and vascular healing via paclitaxel‐coated balloon technology in drug eluting stent restenosis swine model

Li¹,

Téllez²,

Rousselle³

et al. 2015

Cathet Cardio Intervent

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ObjectivesTo evaluate the biological effect of a paclitaxel‐coated balloon (PCB) technology on vascular drug distribution and healing in drug eluting stent restenosis (DES‐ISR) swine model.BackgroundThe mechanism of action and healing response via PCB technology in DES‐ISR is not completely understood.MethodsA total of 27 bare metal stents were implanted in coronary arteries and 30 days later the in‐stent restenosis was treated with PCB. Treated segments were harvested at 1 hr, 14 days and 30 days post treatment for the pharmacokinetic analysis. In addition, 24 DES were implanted in coronary arteries for 30 days, then all DES‐ISRs were treated with either PCB (n = 12) or uncoated balloon (n = 12). At day 60, vessels were harvested for histology following angiography and optical coherence tomography (OCT).ResultsThe paclitaxel level in neointimal tissue was about 18 times higher (P = 0.0004) at 1 hr C max, and retained about five times higher (P = 0.008) at day 60 than that in vessel wall. A homogenous distribution of paclitaxel in ISR was demonstrated by using fluorescently labeled paclitaxel. Notably, in DES‐ISR, both termination OCT and quantitative coronary angioplasty showed a significant neointimal reduction and less late lumen loss (P = 0.05 and P = 0.03, respectively) post PCB versus post uncoated balloon. The PES‐ISR + PCB group displayed higher levels of peri‐strut inflammation and fibrin scores compared to the ‐limus DES‐ISR + PCB group.ConclusionsIn ISR, paclitaxel is primarily deposited in neointimal tissue and effectively retained over time following PCB use. Despite the presence of metallic struts, a uniform distribution was characterized. PCB demonstrated an equivalent biological effect in DES‐ISR without significantly increasing inflammation. © 2015 Wiley Periodicals, Inc.

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“…Subsequent drug-coated balloon catheters developed in Europe and the USA came closer to the original principle, which is to use 3 μg paclitaxel/mm² in conjunction with an additive to protect the drug from premature release while at the same time facilitating fast and complete release upon balloon inflation at the target site. Examples are DIOR™ II (EuroCor, Germany) with the film-forming agent shellac as an additive [36,57], In.Pact catheters for coronary and peripheral applications (Medtronic, USA) with urea as an additive [49,51,69], and Pantera™ Lux (Biotronic, Germany) with the amphiphilic butyryl-tri-hexyl citrate as an additive [70]. Several similar developments have been presented but no data published in scientific journals are available.…”

Section: üBersicht 351mentioning

confidence: 99%

“…The tolerance of local overdose, e. g., due to overlapping inflation of paclitaxel-coated balloons either without stents or combined with premounted bare metal stents, has been addressed in preclinical studies in coronary and peripheral arteries. Whereas the treatment of up to 9 or 10 μg/mm² vessel wall administered by a single or two overlapping high dose balloons (iopromide or urea -paclitaxel) was tolerated by porcine coronary arteries [42,49], the treatment of the same vessel segment with 3 high-dose overlapping balloons (urea-paclitaxel-coating) caused thrombotic occlusion of some arteries. Milewski et al [60] found that 2 overlapping balloons did not cause problems but were required to achieve the desired inhibition of neointimal proliferation in porcine peripheral arteries.…”

Section: üBersicht 351mentioning

confidence: 99%

Drug-Coated Balloons for Restenosis Prophylaxis

Speck

Scheller

Hamm

2013

Fortschr Röntgenstr

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Drug-coated balloons for restenosis prophylaxis provide a high local drug concentration with minimal or no systemic adverse effects. Their development was both delayed and facilitated by the introduction of drug-eluting stents: delayed because sustained release kinetics from stent platforms seemed to be essential and facilitated because prior experience with stents allowed selection of testing methods and drugs. Currently, a variety of drug-coated balloons are available, basically consisting of a coating containing paclitaxel at a dose of about 3??g/mm? balloon surface, and different additives influencing the adherence and release of the drug, e.?g., contrast agent, urea, or various amphiphilic compounds. The drug is almost completely released during a single inflation of 30???60 seconds. Studies in animals and several independent randomized clinical trials in coronary and peripheral arteries demonstrate effective reduction of neointimal proliferation, restenosis, and revascularization persisting for at?least 2 years or 5 years according to one study in coronary arteries. Drug-coated balloons are preferably used for treating coronary in-stent restenosis and de novo and restenotic lesions in peripheral vessels. No coating-related adverse events have been observed in clinical trials. Persistent efficacy may be explained by the long residence time of paclitaxel in tissue or inhibition of an essential first step in the chain of events leading to neointimal proliferation. Citation Format: ??Speck U., Scheller B., Hamm B. Drug-Coated Balloons for Restenosis Prophylaxis. Fortschr R?ntgenstr 2014; 186: 348???358

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Dose Response to Paclitaxel-Coated Balloon Catheters in the Porcine Coronary Overstretch and Stent Implantation Model

Abstract: In the animal model, 2 paclitaxel matrix formulations were similar in respect of uptake in the vessel wall, and effective already at a dose of 1 μg/mm2. Except thrombotic events for the intentionally excessive dose, paclitaxel-coated balloons were well tolerated in the animal model.

Cited by 117 publications

References 24 publications

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Biological effect on drug distribution and vascular healing via paclitaxel‐coated balloon technology in drug eluting stent restenosis swine model

Drug-Coated Balloons for Restenosis Prophylaxis

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