Reduction of Stenosis Due to Intimal Hyperplasia After Stent Supported Angioplasty of Peripheral Arteries by Local Administration of Paclitaxel in Swine

Albrecht, Thomas; Speck, Ulrich; Baier, C.; Wolf, Karl‐Jürgen; Böhm, Michael; Scheller, Bruno

doi:10.1097/rli.0b013e31804f5a60

Cited by 58 publications

(37 citation statements)

References 45 publications

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“…46 First, self-expanding (usually nitinol) stents typically used in some cases may actually promote neointimal formation over years, so a single application of an antiproliferative may be less effective. Second, DCBs used for noncoronary arteries are by necessity larger with a greater surface area and thus may result in higher drug losses during transit and inflation.…”

Section: Gray and Granada Drug-coated Balloons For Vascular Restenosimentioning

confidence: 99%

Drug-Coated Balloons for the Prevention of Vascular Restenosis

2010

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Section: Gray and Granada Drug-coated Balloons For Vascular Restenosimentioning

confidence: 99%

Drug-Coated Balloons for the Prevention of Vascular Restenosis

2010

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“…1,2 Recently, percutaneous balloon catheters coated with antiproliferative drugs have been developed with the purpose of reducing restenosis after percutaneous intervention in peripheral vessels. 3 After positive preliminary experience in animal models, 4,5 paclitaxel-coated balloon (PCB) therapy was tested against UCB angioplasty in patients with femoropopliteal artery (FPA) atherosclerotic disease. 6,7 Although late lumen loss (LLL) was significantly reduced, the small number of patients limited the relevance of final results.…”

mentioning

confidence: 99%

Paclitaxel-Coated Versus Uncoated Balloon Angioplasty Reduces Target Lesion Revascularization in Patients With Femoropopliteal Arterial Disease

Cassese

Byrne

Ott

et al. 2012

Circ: Cardiovascular Interventions

114

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Background-In disease of the femoropopliteal artery, paclitaxel-coated balloon (PCB) therapy improved angiographic outcomes as compared with uncoated balloon (UCB) angioplasty. Nevertheless, it remains uncertain whether PCB may reduce the need for reintervention. Methods and Results-We searched Medline, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific session abstracts, and relevant web sites for trials of PCB versus UCB angioplasty. Key words were: "superficial femoral artery," "popliteal artery," "angioplasty," "drug-eluting balloon," "paclitaxel-eluting balloon," and "randomized trial." Inclusion criteria were: (1) randomized design; (2) intention-to-treat analysis; and (3) ≥6-month follow-up. Exclusion criteria were: (1) vessel treated other than femoropopliteal artery; (2)

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“…In another porcine coronary artery study, Speck et al 16 have shown that treatment with a paclitaxel-coated balloon reduced in-stent neointimal area by 54%, whereas sirolimus-eluting stents reduced it by only 26%. In a balloon overstretch and stented porcine peripheral artery model, Albrecht et al 17 have shown that the use of a 480-g paclitaxel-coated balloon allowed a 68% decrease in diameter stenosis and a 56% decrease in late lumen loss.…”

Section: Paclitaxel Deb: Preclinical Trialsmentioning

confidence: 99%

“…Most of these systems were developed before the introduction of DES, with little knowledge about sirolimus and its analogues, and paclitaxel, the only drug proven to reduce restenosis with DES. What we know about DEB is seen in the recent work done with paclitaxel, which includes a series of preclinical [15][16][17][18][19][20][21] and clinical [22][23][24][25][26][27] studies.…”

Section: Technologiesmentioning

confidence: 99%

Drug-Eluting Balloon

Waksman

Pakala

2009

Circ: Cardiovascular Interventions

132

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Balloon angioplasty revolutionized coronary revascularization; however, elastic recoil and restenosis caused by cellular proliferation are major drawbacks of angioplasty. Intracoronary stenting, which could tackle dissections and eliminate elastic recoil, became the next mode of intervention but was limited by stent thrombosis and increased neointimal hyperplasia, leading to in-stent restenosis. Drug-eluting stents significantly attenuate the cellularity and reduce the need for repeat revascularization; however, late stent thrombosis, dependency on prolonged dual antiplatelet therapy, and continued restenosis led to a quest for new treatment modalities. In recent years, drug-eluting balloons (DEB) have emerged as a potential alternative to combat restenosis. Paclitaxel was identified as the primary drug for DEB because of its rapid uptake and prolonged retention. DEB technology demonstrated safety and efficacy in preclinical and in randomized clinical trials for patients with in-stent restenosis. Further studies for de novo lesions in small vessels, for lesions in the superficial femoral artery, and those for below the knee signal its safety and efficacy for broader indications. This review will discuss the rationale, concept, and available DEB technologies, along with preclinical and clinical data, to support the DEB as a new technology for endovascular intervention. It will also assess the potential of the balloon to become the "comeback kid" of percutaneous coronary intervention in the form of DEB.The use of percutaneous balloon angioplasty to recanalize narrowed coronary arteries and endovascular vessels revolutionized revascularization. 1 Balloon angioplasty, however, was associated with subintimal dissection, abrupt vessel closure, and restenosis. Stents tackle dissection, eliminate the elastic recoil and late negative vessel remodeling, 2 but increase inflammation, thereby leading to more intimal hyperplasia resulting in in-stent restenosis (ISR). 3 The major limitation of stents is stent thrombosis, which is controlled with antiplatelet therapy. Drug-eluting stents (DES) are another breakthrough in stent technology because of their ability to minimize cellular proliferation and to reduce restenosis rates to single-digit levels. 4,5 DES carry with them the new phenomena of late and very late stent thrombosis, with a hazard ratio of up to 0.6 per year as a result of delayed healing, local inflammation, and impaired endothelial function, which lead to prolonged dual antiplatelet therapy. 6 Restenosis is also reported with DES, especially in complex subsets of patients and lesions. 7 These DES limitations prompted innovation for improved solutions, such as the local delivery of drugs via nonstent-based platforms, including drug-eluting balloons (DEB). This review will discuss the rationale, concept, and available DEB technologies, along with the preclinical and clinical data available to support the DEB as a new technology for endovascular intervention. RationaleRationale for the development of DEB derives m...

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Reduction of Stenosis Due to Intimal Hyperplasia After Stent Supported Angioplasty of Peripheral Arteries by Local Administration of Paclitaxel in Swine

Abstract: Local short-term administration of paclitaxel during PTA of peripheral arteries using balloons or contrast medium as drug carriers reduced stenosis due to intimal hyperplasia.

Cited by 58 publications

References 45 publications

Drug-Coated Balloons for the Prevention of Vascular Restenosis

Drug-Coated Balloons for the Prevention of Vascular Restenosis

Paclitaxel-Coated Versus Uncoated Balloon Angioplasty Reduces Target Lesion Revascularization in Patients With Femoropopliteal Arterial Disease

Drug-Eluting Balloon

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