Attainment of local drug delivery with paclitaxel-eluting balloon in porcine coronary arteries

Department of Cardiology, Medical University of Vienna, Vienna, Austria.
Coronary Artery Disease (Impact Factor: 1.5). 07/2008; 19(4):243-7. DOI: 10.1097/MCA.0b013e3283030b26
Source: PubMed


Our purpose was to confirm the local drug delivery of a paclitaxel-eluting balloon by percutaneous intervention of single arterial segments or bifurcations of porcine coronary arteries.
Eight domestic pigs were subjected to 2 x 30 s Dior balloon dilatation of the mid left anterior descending, left circumflex and proximal right coronary arteries. Bifurcation intervention was performed in six arteries. The dilated, and the distal and proximal reference segments were prepared for tissue paclitaxel concentration measurement. Tissue samples were harvested at mean 1.5, 12, 24 and 48 h after balloon dilatation and plasma samples were taken at various time points.
The tissue paclitaxel concentration of the single dilated segment was at 1.5 h postdilatation 1.82+/-1.60 micromol/l, which decreased significantly to 0.73+/-0.27 (P=0.032), 0.62+/-0.34 and 0.44+/-0.31 micromol/l at 12, 24 and 48 h. The bifurcation intervention resulted in 5.10+/-1.80 micromol/l tissue paclitaxel amount in the main branch, which at 12 h had diminished to 1.41+/-1.23 micromol/l (P=0.004). The bifurcation side contained 7.00+/-4.80 micromol/l paclitaxel at 1.5 h postdilatation, which lowered to 2.72+/-0.40 micromol/l (P=0.034). The mean paclitaxel concentration of the reference segments decreased gradually from 0.84+/-0.99 to 0.34+/-0.36 micromol/l (P=0.09), 0.28+/-0.16 and 0.19+/-0.18 micromol/l tissue at 1.5, 12, 24 and 48 h postdilatation, respectively. No paclitaxel was found in the peripheral blood at any time point.
Short exposure of the coronary artery to paclitaxel with a coated balloon is sufficient for the attainment of an adequate tissue concentration of paclitaxel, which is known to be efficient in inhibiting neointimal growth.

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    • "The goal of using PTA without leaving behind a permanent device, led to the development of drug eluting balloons (DEB) [11]. First experiments with DEBS included paclitaxel-coated balloons (PCB) in pigs [12] [13], and soon DEB was seen as an alternative treatment to plain balloon angioplasty and stent implantation. Studies with promising long-term results with DEB for treating coronary ISR compared with uncoated balloons and paclitaxel-coated stents were published [14] [15] [16] and reports of DEB treatment of lesions in small coronary arteries followed [17] [18]. "
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    ABSTRACT: Background: Drug-eluting balloons (DEB) may be promising technology for treating atherosclerotic arterial disease. In fact, several DEBs have been clinically available for the treatment of coronary in-stent restenosis (ISR), de novo coronary lesions, and peripheral artery disease. Objective: We sought to elucidate the mechanism of action and in vivo safety and efficacy of a novel iopromide-based paclitaxel-eluting balloon. Methods: In vitro cytotoxicity of a novel DEB on human umbilical vein endothelial cells (HUVECs) and in vivo pharmacokinetics of DEB in a rabbit aorta abdominalis were assessed. Then, bare metal stents (BMS) were implanted at both the proximal and distal sites of the rabbit aorta abdominalis. Stented vascular segments were immediately dilated with a bare balloon (control group) or the DEB (DEB group) randomly. Histological evaluation was performed in all treated segments at 28 days. Because paclitaxel is a tubulin-disrupting agent that binds preferentially to β-tubulin, we measured β-tubulin expression in aortal stent specimens via immunohistochemistry. Results: We observed that DEB was compatible and could reduce neointimal hyperplasia compared with the bare balloon. Meanwhile, immunohistochemistry revealed that β-tubulin expression in the DEB group increased compared with the control group, indirectly suggesting successful uptake of paclitaxel by vessel walls after DEB dilation. Conclusions: The novel DEB is safe and has a favorable vascular healing response on neointimal hyperplasia.
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    • "Recently, non-stent-based local balloon delivery systems have been developed for the delivery of antiproliferative drugs. The concept behind this technology is that the rapid release of antiproliferative drugs into arterial tissue is more effective than their gradual release, as exemplified by DESs.5)6) Another benefit of drug-eluting balloon (DEB) based technology is that it is potentially cheaper as balloon catheters are invariably cheaper than stents. "
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    ABSTRACT: The drug-eluting balloon (DEB) catheter system was developed to treat restenosis. Furthermore, DEB angioplasty has been shown to reduce restenosis risk when compared to drug-eluting stents (DES) in patients with in-stent restenosis (ISR) or small vessel disease (SVD). In addition, DEB angioplasty reduces costs due to fewer revascularizations and reduced clopidogrel treatment length. The objective of this study was to predict the expected cost-savings when DEB is substituted for DES in patients with ISR or SVD. The subjects included were patients treated by DES at Seoul National University Hospital from January 2006 to June 2009, with clinical data after percutaneous coronary intervention, were. A model was developed to allow the costs of DES and the calculated costs of DEB incurred by patients with ISR or SVD to be compared. The overall cost of DEB was calculated to be 1,256,150 won and the overall cost of DES was 2,102,500 won, and the cost of clopidogrel was 2,168 won. Expected repeat revascularizations within 12 months of DEB were calculated based on information provided by the Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery (PEPCAD) I and II trials. By substituting DEB for DES, total cost (including the cost of initial DEB treatment, the cost of repeat revascularization after DEB treatment, and the cost of clopidogrel treatment) was found to be 34% lower in ISR patients and 48% lower in SVD patients. DEB angioplasty will significantly reduce costs as compared to DES in ISR and in SVD patients.
    Full-text · Article · Dec 2011 · Korean Circulation Journal
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    ABSTRACT: Summary Drug-eluting balloons use paclitaxel as active sub- stance on account of its high absorption rate, rapid as- similation by the intima and long-lasting effect. Clini- cal studies have investigated the safety and effective- ness of drug-eluting balloons in various clinical scenarios and support the use of paclitaxel-eluting bal- loons for the treatment of in-stent restenoses with a re- ference-vessel diameter of ≥2.5 mm. However, current evidence does not warrant treating first-time stenoses and bifurcation lesions with drug-eluting balloon cath- eters.
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