Systematic Review and Meta-Analysis of Drug-Eluting Balloon and Stent for Infrapopliteal Artery Revascularization

Xu, Xiaowei; Kong, Jie; Xu, Rongwei; Fan, Xueqiang; Chen, Jie; Zheng, Xiaoyan; Ma, Bo; Sun, Mingsheng; Ye, Zhidong; Liu, Peng

doi:10.1177/1538574416689426

Cited by 27 publications

(23 citation statements)

References 39 publications

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“…These drugs inhibit postintervention inflammation and neointimal hyperplasia. [40][41][42] DESs were initially developed for the coronary circulation, and a wide body of evidence supports their safety and efficacy in the coronary arteries. 39 Coronary DES significantly reduce reintervention rate in 5-year follow-up studies compared to BMS with similar long-term safety profile.…”

Section: Drug-eluting Stentsmentioning

confidence: 99%

“…These meta-analyses all report improved freedom from TLR and primary patency with DES when compared with PTA and BMS without impact on overall survival. 41,[73][74][75] Two meta-analyses report improvement in amputation rate, 41,74 while a third 73 reports no difference. Of note, the majority of studies included in these meta-analyses reported 12-month data.…”

Section: Infrapoplitealmentioning

confidence: 99%

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Drug-Eluting Balloons and Drug-Eluting Stents in the Treatment of Peripheral Vascular Disease

Lindquist¹,

Schramm²

2018

Semin intervent Radiol

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In the last 20 years, peripheral artery disease (PAD) has been increasingly recognized as a significant cause of morbidity and mortality in the United States. The endovascular treatment of PAD has seen a marked rise as minimally invasive techniques and devices have been refined. Two newer devices, drug-eluting stents and drug-eluting balloons, are on the forefront of the battle against limb loss from PAD. This review focuses on the data backing the use of drug-eluting technologies for use in the peripheral arterial system.

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Section: Drug-eluting Stentsmentioning

confidence: 99%

Section: Infrapoplitealmentioning

confidence: 99%

Drug-Eluting Balloons and Drug-Eluting Stents in the Treatment of Peripheral Vascular Disease

Lindquist¹,

Schramm²

2018

Semin intervent Radiol

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“…Katsanos et al reported reduced restenosis, TLR, amputation, and improved wound healing when compared to control (Bare Metal Stent or PBA), without any impact on mortality. 13 These findings have been corroborated, 14 however, most would agree that trial numbers are small in selected centers and selected lesions and further clinical evidence is clearly required, particularly in regard to DEB.…”

Section: Discussionmentioning

confidence: 89%

Comparison of Outcomes Following Infrapopliteal Plain Balloon Angioplasty in the BASIL Trial (1999-2004) and in a Contemporary Series (2009-2013)

Popplewell

Davies

Renton

et al. 2019

Vasc Endovascular Surg

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Objectives: To compare outcomes in patients randomized to infrapopliteal (IP) plain balloon angioplasty (PBA) for chronic limb-threatening ischemia within the Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL)-1 trial between 1999 and 2004 with outcomes in consecutive patients undergoing IP PBA at an academic vascular unit a decade later (2009-2013, Contemporary series [CS]). Methods: Individual patient data were obtained from prospective BASIL-1 (48 patients) and CS databases (73 patients). All had a minimum of 3-years of follow-up. Outcomes studied were amputation-free survival (AFS), overall survival (OS), major (above ankle) limb amputation, arterial reintervention, immediate technical success, and length of hospital stay for the index procedure and during the following 12-month period. Statistical analysis was performed using SAS version 9.4. Results: The BASIL and CS cohorts were well matched for gender, age, diabetes, previous stroke, myocardial infarction and arterial intervention, and presence of tissue loss. More patients in BASIL-1 underwent concomitant treatment of the superficial femoral (60% vs 37%, P = .01) and above knee popliteal (60% vs 34%, P = .005) arteries. Immediate technical success increased from 73% in BASIL-1 to 90% in the CS ( P = .01). Between the two cohorts, there were no differences in AFS (hazard ratio [HR] = 1.00, 95% confidence interval [CI]: 0.65-1.54, P = 1.0), OS (HR = 1.04, 95% CI: 0.66-1.62, P = .9), major amputation (HR = 0.86, 95% CI: 0.37-1.97, P = .7), or reintervention (HR = 0.61, 95% CI: 0.29-1.27, P = .2). Contemporary series patients spent significantly fewer days in hospital following the index procedure ( P = .02) and also over the following 12 months ( P = .002). Conclusions: Despite improvements in the immediate technical angiographic success of IP PBA between BASIL and the CS, there were no significant improvements in survival outcomes. Results from BASIL-2 and BEST-CLI are required in order to properly define the clinical and cost-effectiveness of endovascular treatment in such patients.

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“…In one of the only long-term (2 year) real-world registries, results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions of the femoropopliteal (above-the-knee) region ( Schmidt et al, 2016 ). For the treatment of infrapopliteal (below-the-knee) disease, DCB have shown to be less effective with no clinical benefit over standard non-coated balloons ( Zeller et al, 2014 ; Zhang et al, 2017 ). These clinical studies confirm the benefits of DCB clinically, however, improvements to DCB are needed to recover long-term clinical results.…”

Section: Discussionmentioning

confidence: 99%

In vitro and in vivo Assessment of Keratose as a Novel Excipient of Paclitaxel Coated Balloons

et al. 2018

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Purpose: Drug coated balloons (DCB) are continually improving due to advances in coating techniques and more effective excipients. Paclitaxel, the current drug choice of DCB, is a microtubule-stabilizing chemotherapeutic agent that inhibits smooth muscle cell proliferation. Excipients work to promote coating stability and facilitate paclitaxel transfer and retention at the target lesion, although current excipients lack sustained, long-term paclitaxel retention. Keratose, a naturally derived protein, has exhibited unique properties allowing for tuned release of various therapeutic agents. However, little is known regarding its ability to support delivery of anti-proliferative agents such as paclitaxel. The goal of this project was to thus demonstrate the feasibility of keratose as a DCB-coating excipient to promote the release and delivery of paclitaxel.Methods: Keratose was combined with paclitaxel in vitro and the release kinetics of paclitaxel and keratose were evaluated through high performance liquid chromatograph-mass spectroscopy (HPLC-MS) and spectrophotometry, respectively. A custom coating method was developed to deposit keratose and paclitaxel on commercially available angioplasty balloons via an air spraying method. Coatings were then visualized under scanning electron microscopy and drug load quantified by HPLC-MS. Acute arterial transfer of paclitaxel at 1 h was assessed using a novel ex vivo model and further evaluated in vivo in a porcine ilio-femoral injury model.Results: Keratose demonstrated tunable release of paclitaxel as a function of keratose concentration in vitro. DCB coated via air spraying yielded consistent drug loading of 4.0 ± 0.70 μg/mm2. Under scanning electron microscopy, the keratose-paclitaxel DCB showed uniform coverage with a consistent, textured appearance. The acute drug transfer of the keratose-paclitaxel DCB was 43.60 ± 14.8 ng/mg at 1 h ex vivo. These measurements were further confirmed in vivo as the acute 1 h arterial paclitaxel levels were 56.60 ± 66.4 ng/mg.Conclusion: The keratose-paclitaxel coated DCB exhibited paclitaxel uptake and achieved acute therapeutic arterial tissue levels, confirming the feasibility of keratose as a novel excipient for DCB.

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Systematic Review and Meta-Analysis of Drug-Eluting Balloon and Stent for Infrapopliteal Artery Revascularization

Cited by 27 publications

References 39 publications

Drug-Eluting Balloons and Drug-Eluting Stents in the Treatment of Peripheral Vascular Disease

Drug-Eluting Balloons and Drug-Eluting Stents in the Treatment of Peripheral Vascular Disease

Comparison of Outcomes Following Infrapopliteal Plain Balloon Angioplasty in the BASIL Trial (1999-2004) and in a Contemporary Series (2009-2013)

In vitro and in vivo Assessment of Keratose as a Novel Excipient of Paclitaxel Coated Balloons

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