Biologic Drug Effect and Particulate Embolization of Drug-Eluting Stents versus Drug-Coated Balloons in Healthy Swine Femoropopliteal Arteries

Torii, Sho; Yahagi, Kazuyuki; Mori, Hiromu; Harari, Emanuel; Romero, Maria; Kolodgie, Frank D.; Young, Brandt; Ragheb, Anthony; Virmani, Renu; Finn, Aloke V.

doi:10.1016/j.jvir.2018.02.006

Cited by 26 publications

(18 citation statements)

References 25 publications

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“…Our preclinical studies in healthy swine iliofemoral artery model support this idea since DES treatment demonstrated significantly higher drug effect (medial SMC loss score) vs DCB61,62 (Figure 4). Importantly, the median value of circumferential medial SMC loss score was lower (1.2) in DCB than in DES (3.5) treatment groups (scores were dependent on the circumferential distribution of the drug as assessed by loss of SMCs with score of 1= <25%; 2=25 to <50%; 3=50 to <75%, and 4= >75%).…”

Section: Drug Effect Of Dcbsmentioning

confidence: 54%

“… Source: Reprinted from Journal of Vascular and Interventional Radiology, 29, Sho Torii,Kazuyuki Yahagi, Hiroyoshi Mori, Emanuel Harari, Maria E. Romero, Frank D. Kolodgie, Brandt Young, Anthony Ragheb, Renu Virmani, Aloke V. Finn, Biologic drug effect and particulate embolization of drug-eluting stents versus drug-coated balloons in healthy swine femoropopliteal arteries, 1041–1049., © 2018, with permission from Elsevier 61…”

Section: Figurementioning

confidence: 99%

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IN.PACTTM AdmiralTM drug-coated balloons in peripheral artery disease: current perspectives

Torii¹,

Kolodgie²,

Virmani³

et al. 2019

MDER

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Endovascular therapy has evolved as a main treatment option especially in patients with short (<25 cm) femoropopliteal lesion. The latest guideline recommends the use of drugeluting devices (both drug-coated balloons [DCBs] and drug-eluting stents) in short femoropopliteal lesions as class IIb recommendation. DCB usage is also recommended for in-stent restenosis lesions (class IIb). DCBs are a more attractive treatment option because the lack of metal prosthesis allows for more flexibility in future treatment options including the option of treating nonstenting zones, previously DCB-treated zones with DCBs again. The IN.PACT™ Admiral™ DCB has shown promising clinical performance in several randomized control trials and global registries, and is currently the market DCB leader for the treatment of femoropopliteal lesions with more than 200,000 patients treated thus far. Currently, more than 10 DCBs have received Conformité Européene mark for the treatment of femoropopliteal atherosclerotic disease. Three of these (including IN.PACT Admiral DCBs) have also received Food and Drug Administration approval in the USA. However, some Conformité Européene-marked DCBs have failed to show consistent results in their clinical studies suggesting all DCBs are not created equal. Each DCB is unique (ie, drug type, drug dose, crystallinity, and excipient) with different clinical outcomes. In the current review, we will focus on the preclinical and clinical results of not only IN.PACT Admiral DCB, but also the other currently available DCBs.

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Section: Drug Effect Of Dcbsmentioning

confidence: 54%

Section: Figurementioning

confidence: 99%

IN.PACTTM AdmiralTM drug-coated balloons in peripheral artery disease: current perspectives

Torii¹,

Kolodgie²,

Virmani³

et al. 2019

MDER

Self Cite

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“…Preclinical studies have shown ~1%–10% of the paclitaxel coated on DCBs get transferred into the arterial wall, with the remaining (up to 90%) lost into the circulation . Recent pre‐clinical publications has shown DCB coating particulates (lost into circulation) lead to fibrinoid necrosis within downstream skeletal muscle tissue …”

Section: Discussionmentioning

confidence: 99%

“…22,24 Recent pre-clinical publications has shown DCB coating particulates (lost into circulation) lead to fibrinoid necrosis within downstream skeletal muscle tissue. 17,25 The fundamental delivery approach of the OPC also differs from DCBs. In liquid delivery using the OPC, pressure in the treatment chamber uniformly delivers liquid paclitaxel into the vessel wall regardless of the cross-sectional shape of the vessel.…”

Section: Treatment Of Btk Disease Remains a Major Hurdle In Endovascularmentioning

confidence: 99%

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A universal drug delivery catheter for the treatment of infrapopliteal arterial disease using liquid therapy

Bunch

Nair

Aggarwala

et al. 2020

Cathet Cardio Intervent

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Objective: The objective of this study was to investigate the safety and feasibility of treating infrapopliteal lesions using a novel drug delivery catheter locally delivering liquid paclitaxel. Background: Balloon angioplasty is currently the Gold Standard to treat below-theknee disease; however, restenosis continues to be a great challenge following these percutaneous revascularization procedures. Methods: The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis (COPPER-A) study-Below-the-Knee Cohort was a prospective, nonrandomized, multicenter, feasibility, and safety study that enrolled 35 patients at 11 participating sites. The safety endpoints at 1, 3, and 6 months were freedom from thrombosis, major amputation in the target limb and target limb related death. The efficacy endpoints were primary patency and freedom from clinically driven target lesion revascularization at 6 months. Results: All patients tolerated the procedure well with no reports of adverse procedural events. Thirty-five patients were treated with a mean lesion length of 112 ± 81.2 mm with the lesion length range of 20-286 mm. At 6-month follow-up, primary patency was 89.3% and freedom from clinically driven target lesion revascularization was 96.4%. No patients demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1-, 3-and 6-months follow-up intervals. Conclusions: The results of this multi-center study demonstrated that infrapopliteal arteries can be safely and effectively treated with liquid paclitaxel using the occlusion perfusion catheter.

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Drug‐coated balloon angioplasty is a well‐established treatment and in everyday use in cathlabs worldwide

Rissanen,

Kleber,

Scheller

2023

Cathet Cardio Intervent

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Biologic Drug Effect and Particulate Embolization of Drug-Eluting Stents versus Drug-Coated Balloons in Healthy Swine Femoropopliteal Arteries

Cited by 26 publications

References 25 publications

<p>IN.PACT<sup>TM</sup> Admiral<sup>TM</sup> drug-coated balloons in peripheral artery disease: current perspectives</p>

<p>IN.PACT<sup>TM</sup> Admiral<sup>TM</sup> drug-coated balloons in peripheral artery disease: current perspectives</p>

A universal drug delivery catheter for the treatment of infrapopliteal arterial disease using liquid therapy

Drug‐coated balloon angioplasty is a well‐established treatment and in everyday use in cathlabs worldwide

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