Paclitaxel-Coated Balloon in Infrapopliteal Arteries

Zeller, Thomas; Beschorner, Ulrich; Pilger, Ernst; Bosiers, Marc; Deloose, Koen; Peeters, Patrick; Scheinert, Dierk; Schulte, Karl-Ludwig; Rastan, Aljoscha; Brodmann, Marianne

doi:10.1016/j.jcin.2015.07.011

Cited by 157 publications

(32 citation statements)

References 19 publications

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“…The improvement of both parameters was significantly higher in the DCB group in the DEBATE BTK study (Table 3). 27 Amputation rates at 12 months were lower in the DCB group in the DEBELLUM, DEBATE-BTK, and BIOLUX-PII studies 28…”

Section: Outcomes Of Dcb Use In Below-the-knee Lesions: Rcts and Compmentioning

confidence: 94%

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Herten¹,

Torsello²,

Schönefeld³

et al. 2016

VHRM

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Peripheral arterial disease, particularly critical limb ischemia, is an area with urgent need for optimized therapies because, to date, vascular interventions often have limited life spans. In spite of initial encouraging technical success after femoropopliteal percutaneous transluminal angioplasty or stenting, postprocedural restenosis remains the major problem. The challenging idea behind the drug-coated balloon (DCB) concept is the biological modification of the injury response after balloon dilatation. Antiproliferative drugs administered via DCBs or drug-eluting stents are able to suppress neointimal hyperplasia, the main cause of restenosis. This article reviews the results of DCB treatments of femoropopliteal and infrapopliteal lesions in comparison to standard angioplasty with uncoated balloons. A systematic literature search was performed in 1) medical journals (ie, MEDLINE), 2) international registers for clinical studies (ie, www.clinicaltrials.gov), and 3) abstracts of scientific sessions. Several controlled randomized trials with follow-up periods of up to 5 years demonstrated the efficacy of paclitaxel –DCB technology. However, calcified lesions seem to affect the efficacy of DCB. Combinations of preconditioning methods with DCBs showed promising results. Although the mechanical abrasion of calcium via atherectomy or laser ablation showed favorable periprocedural results, the long-term impact on restenosis and clinical outcome has to be demonstrated. Major advantages of the DCBs are the rapid delivery of drug at uniform concentrations with a single dose, their efficacy in areas wherein stents have been contraindicated until now (ie, bifurcation, ostial lesions), and in leaving no stent scaffold behind. Reinterventions are easier to perform because DCBs leave no metal behind. Various combinations of DCBs with other treatment modalities may prove to be viable options in future. The follow-up results of clinical studies will evaluate the long-term impact of DCBs.

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Section: Outcomes Of Dcb Use In Below-the-knee Lesions: Rcts and Compmentioning

confidence: 94%

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Herten¹,

Torsello²,

Schönefeld³

et al. 2016

VHRM

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“…Простые баллоны и покрытые паклитакселом были исследованы [25] при лечении 72 пациентов с атеросклеротическим поражением берцовых артерий. Через 1 г получены следующие результаты: первичная сосудистая проходимость составила 50,8% в группе покрытого баллона и 45,6% в группе ангиопластики (р=0,09).…”

Section: результаты ангиопластики и стентирования с покрытием и без пunclassified

“…В таком случае эндоваскулярные методы являются операцией выбора. При коротких поражениях артерий голени стенты с покрытием показали преимущество в свободе от ампутации и рестеноза оперированного сосуда [3,25,37]. Однако в практических условиях довольно часто поражение составляет >30 мм, поэтому сложно выделить преимущества покрытых стентов перед покрытыми баллонами.…”

Section: результаты ангиопластики и стентирования с покрытием и без пunclassified

Modern endovascular methods in treatment of patients with the tibial arteries lesion: determinants and perspectives

Чебан

Karpenko

Popova

et al. 2018

Cardiovasc Ther Prev

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Endovascular interventions have proved efficacy in the treatment of the shin arteries lesion management. Lots of published works witness on the significance and future perspective of the field. The article is focused on the analysis of studies for previous 5 years, on various treatment approaches, balloons and cytostatics coated stents usage. The ways for interventions relsults improvement are sketched on tibial arteries with drug eluting stents.

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“…With the withdrawal of the Amphirion balloon, there have been new entrants in the BTK DCB market including Biotronik’s Passeo-18 LUX drug-releasing PTA balloon catheter, which was compared to the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries (BIOLUX P-II trial). 50 The Passeo-18 Lux DCB varies from the Medtronic Amphirion in that paclitaxel is incorporated into a delivery excipient of BTHC. This was a prospective, multicenter, randomized first-in-man study enrolling 72 patients who were randomized to either the Passeo-18 LUX DEB (Biotronik AG) or Passeo-18 PTA.…”

Section: Dcb Versus Pta For Infrapopliteal Diseasementioning

confidence: 99%

New developments in the clinical use of drug-coated balloon catheters in peripheral arterial disease

Naghi

Yalvac

Pourdjabbar

et al. 2016

MDER

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Peripheral arterial disease (PAD) involving the lower extremity is a major source of morbidity and mortality. Clinical manifestations of PAD span the spectrum from lifestyle limiting claudication to ulceration and gangrene leading to amputation. Advancements including balloon angioplasty, self-expanding stents, drug-eluting stents, and atherectomy have resulted in high technical success rates for endovascular therapy in patients with PAD. However, these advances have been limited by somewhat high rates of clinical restenosis and clinically driven target lesion revascularization. The recent introduction of drug-coated balloon technology shows promise in limiting neointimal hyperplasia induced by vascular injury after endovascular therapies. This review summarizes the contemporary clinical data in the emerging area of drug-coated balloons.

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Paclitaxel-Coated Balloon in Infrapopliteal Arteries

Abstract: The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA.

Cited by 157 publications

References 19 publications

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Modern endovascular methods in treatment of patients with the tibial arteries lesion: determinants and perspectives

New developments in the clinical use of drug-coated balloon catheters in peripheral arterial disease

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Paclitaxel-Coated Balloon in Infrapopliteal Arteries

Abstract: The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA.

Cited by 157 publications

References 19 publications

Critical appraisal of paclitaxel balloon angioplasty for femoral&ndash;popliteal arterial disease

Critical appraisal of paclitaxel balloon angioplasty for femoral&ndash;popliteal arterial disease

Modern endovascular methods in treatment of patients with the tibial arteries lesion: determinants and perspectives

New developments in the clinical use of drug-coated balloon catheters in peripheral arterial disease

Contact Info

Product

Resources

About

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease

Critical appraisal of paclitaxel balloon angioplasty for femoral–popliteal arterial disease