Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug‐coated balloon in a swine femoral artery model

Yazdani, Saami K.; Pacheco, Erica; Nakano, Masataka; Otsuka, Fumiyuki; Naisbitt, Scott; Kolodgie, Frank D.; Ladich, Elena; Rousselle, Serge; Virmani, Renu

doi:10.1002/ccd.24995

Cited by 84 publications

(67 citation statements)

References 26 publications

(33 reference statements)

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“…There was no evidence of ischemic change downstream to the use of DCB or emboli or systemic toxicity observed at any time point. These findings indicate desired pharmacologic levels with biological effect in the treated arteries consistent with safety of the Lutonix DCB (Yazdani et al 2014).…”

Section: Drug-coated Balloons (Dcb)supporting

confidence: 67%

“…The paclitaxel coronary level at 30 min is 165 ng/mg with an exponential decline over 7 days with the highest levels seen in the midsection reaching close to 50 ng/mg (Radke et al 2011). Recently, we evaluated the safety of Lutonix ® DCB with a 2 mg/mm 2 paclitaxel and a carrier comprised of polysorbate and sorbitol in a swine femoral artery model (Yazdani et al 2014). A total of 45 swine were treated with low-pressure balloon inflation either 1Â clinical dose (single inflation, 2 mg/mm 2 paclitaxel) or 4Â dose (2 DCBs, each with a 4 mg/mm 2 paclitaxel) or control (uncoated) balloon.…”

Section: Drug-coated Balloons (Dcb)mentioning

confidence: 99%

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Vascular Pathology and Interventional Treatments

Sakakura

Otsuka

Yahagi

et al. 2014

PanVascular Medicine

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Percutaneous coronary interventions (PCI) have dramatically changed the treatment of coronary artery disease in the past two decades. Before the era of PCI, patients continued to suffer from severe coronary artery disease such as angina pectoris while receiving medical therapy or had to undergo coronary artery bypass surgery (CABG) which required protracted hospital stay along with long recovery time. Today's treatment options in this medical field comprise percutaneous interventional procedures including implantation of bare metal stent (BMS) or drug-eluting stent (DES) or use of drug-eluting balloons in the absence of a scaffolding device. Most often, these interventional procedures occur without any significant hospital stay. Alternatively, patients may undergo minimally invasive coronary artery bypass grafting (CABG) or a hybrid procedure involving both surgical and interventional procedures. Despite the irresistible development of PCI, there remain inherent drawbacks of this technology that need thorough investigation in pathologic and clinical studies. In this chapter, we will focus on the pathology induced by different interventional procedures and the complication that may arise from their use.

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Section: Drug-coated Balloons (Dcb)supporting

confidence: 67%

Section: Drug-coated Balloons (Dcb)mentioning

confidence: 99%

Vascular Pathology and Interventional Treatments

Sakakura

Otsuka

Yahagi

et al. 2014

PanVascular Medicine

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“…There are few preclinical studies conducted that analyze the behavior of DCB [13,17,18]. PTX Blood sample and tissue values are not comparable because of the different animal models, vessel used, DCB technology, inflation protocol, and measurement equipment and methodology.…”

Section: Discussionmentioning

confidence: 97%

“…In our study, we have used a low injury model to determine drug retention by the vessel wall and PTX behavior in the bloodstream. This model has proven to be appropriate to test the biological effects of PTX delivered in a DCB [13]. In order to resemble in-human PTA, we have used native vessel without foreign material (stents), based on the constant anatomical landmark of the gluteal artery.…”

Section: Discussionmentioning

confidence: 99%

Pharmacokinetic Evaluation of Two Paclitaxel-Coated Balloons with Different Drug Load in a Short-Term Porcine Study

Abadal

Vázquez

Morales

et al. 2016

Cardiovasc Intervent Radiol

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Blood PTX was higher when using 3.0 µg/mm(2) DCB, with a peak drug concentration at 1-min, although the drug was undetectable at 24 h, independently of the loading dose. This study demonstrates no difference in arterial wall uptake of a low dose DCB (1.0 µg/mm(2)), when compared to a common dose DCB (3.0 µg/mm(2)) suggesting that the dose of drug in the DCB could be reduced obtaining a similar clinical effect.

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“…Qualitative histological assessment on healing was performed using standardized score system. 12 Peristrut inflammation was evaluated using a standardized inflammatory score for each individual strut. The grading is as follows: 0, no inflammatory cells surrounding the strut; 1, light, noncircumferential lymphohistocytic infiltrate surrounding the strut; 2, localized, moderate to dense cellular aggregate surrounding the strut noncircumferentially; and 3, circumferential dense lymphohistiocytic cell infiltration of the strut.…”

Section: Histological Analysismentioning

confidence: 99%

Impact of Fluoropolymer-Based Paclitaxel Delivery on Neointimal Proliferation and Vascular Healing

Gąsior

Cheng

Valencia

et al. 2017

Circ: Cardiovascular Interventions

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Background-A polymer-free peripheral paclitaxel-eluting stent (PES, Zilver PTX, Cook, IN) has shown to improve vessel patency after superficial femoral angioplasty. A new-generation fluoropolymer-based PES (FP-PES; Eluvia, Boston Scientific, MA) displaying more controlled and sustained paclitaxel delivery promise to improve the clinical outcomes of first-generation PES. We sought to compare the biological effect of paclitaxel delivered by 2 different stent-coating technologies (fluoropolymer-based versus polymer-free) on neointimal proliferation and healing response in the familial hypercholesterolemic swine model of femoral restenosis. Methods and Results-The biological efficacy of clinically available FP-PES (n=12) and PES (n=12) Histological evaluation showed larger lumen areas and evidence of higher biological activity (smooth muscle cell loss and fibrin deposition) in the FP-PES compared with PES and bare metal stent. Conclusions-In the familial hypercholesterolemic swine model of femoral restenosis, the implantation of an FP-PES resulted in lower levels of neointimal proliferation and sustained biological effect ≤90 days compared with a polymerfree stent-based approach. (Circ Cardiovasc Interv. 2017;10:e004450.

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Vascular, downstream, and pharmacokinetic responses to treatment with a low dose drug‐coated balloon in a swine femoral artery model

Abstract: The findings indicate desired pharmacologic levels with biologic effects at early and healing at late time points in the treated arteries, without evidence of significant downstream emboli or systemic toxicity, consistent with safety of the Lutonix DCB.

Cited by 84 publications

References 26 publications

Vascular Pathology and Interventional Treatments

Vascular Pathology and Interventional Treatments

Pharmacokinetic Evaluation of Two Paclitaxel-Coated Balloons with Different Drug Load in a Short-Term Porcine Study

Impact of Fluoropolymer-Based Paclitaxel Delivery on Neointimal Proliferation and Vascular Healing

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