Drug-Coated Balloons: Drugs Beyond Paclitaxel?

Background: Although controversially discussed, paclitaxel is the only clinically proven drug that inhibits restenosis when released from drug-coated balloons (DCBs). Limus drugs are currently being explored as alternatives. The aim of the preclinical studies was to investigate drug candidates beyond paclitaxel considered for balloon coating.

Improvement of Outcome for Treatment of 'Restenosis-prone' Vascular Lesions? Potential Impact of the Paclitaxel dose on Late Lumen Loss in Porcine Peripheral Arteries.

Purpose: Clinical data indicate that the drug density on drug-coated balloons (DCBs) might have a role on treatment effect and durability. The aim of the current study was to investigate inhibition of neointimal formation and potential adverse effects after treatment with a novel double-dose DCB in swine.

Material And Methods: A four-week study was performed in peripheral arteries of 12 domestic pigs after vessel injury and stent implantation.

Drug-coated Balloons in the Neurovascular Setting: A Comprehensive, Systematic Review of Current Use and Indications.

Background: Drug-coated balloons (DCB) are an established tool in the prevention and treatment of coronary and peripheral artery restenosis. The underlying effects of restenosis resemble those in the neurovascular field, yet data on the use of DCB in cervical and intracranial arteries is rare.

Methods: Medline, and international and major national guidelines and recommendations were systematically searched for data addressing the use of DCB in the neurovascular setting.

A novel paclitaxel coated balloon with increased drug transfer for treatment of complex vascular lesions.

Background: Drug coated balloons (DCB) with paclitaxel (Ptx) dose of 2-3.5 μg/mm2 balloon surface inhibit restenosis with different effectiveness and duration of success. A clinical dose finding study is not known for any of the currently marketed products.

Mobile snapshot hyperspectral imaging device for skin evaluation using diffractive optical elements.

Objective: A mobile handheld snapshot hyperspectral imaging device was developed and tested for in vivo skin evaluation using a new spectral imaging technology.

Methods: The device is equipped with four different LED light sources (VIS, 810 nm, 850 nm, and 940 nm) for illumination. Based on a diffractive optical element (DOE) combined with a CMOS sensor chip, a snapshot hyperspectral imager is achieved for the application on human skin.

Efficacy and safety of a magnesium stearate paclitaxel coated balloon catheter in the porcine coronary model.

Background: Local administration of growth-inhibiting substances such as paclitaxel or sirolimus could reduce the risk of restenosis. In the drug coated balloon (DCB) technology the coating and the applied dose seem to play a major role. The aim of the present preclinical studies was to investigate the efficacy and safety of a specific DCB with paclitaxel as active ingredient and magnesium stearate as excipient.

Paclitaxel-Coated Balloon vs Uncoated Balloon Angioplasty for Treatment of In-Stent Restenosis in the Superficial Femoral and Popliteal Arteries: The COPA CABANA Trial.

To investigate the efficacy and sustainability of drug-coated balloon (DCB) treatment of femoropopliteal in-stent restenosis (ISR). An investigator-initiated, prospective, multicenter, 1:1 randomized study enrolled 88 patients for treatment of ISR with DCB (n=47; mean age 68.3±9.

Correction to: Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials.

In their recently published pooled analysis of four drug-coated balloon (DCB) studies, which focused on the impact of patient and lesion characteristics on LLL at 6 months (Albrecht T et al. Cardiovasc Intervent Radiol. 2018 Dec 11.

Impact of Patient and Lesion Characteristics on Drug-Coated Balloon Angioplasty in the Femoropopliteal Artery: A Pooled Analysis of Four Randomized Controlled Multicenter Trials.

Objectives: The principal objective of this pooled analysis was to investigate various patient and lesion characteristics on late lumen loss (LLL) after drug-coated balloon (DCB) angioplasty.

Background: Four randomized controlled trials (THUNDER, FEMPAC, PACIFIER, CONSEQUENT) were pooled to investigate the influence of various patient and lesion characteristics on DCB angioplasty and on plain old balloon angioplasty (POBA) in patients with femoropopliteal artery disease.

Methods: Angiographic data from 355 patients were pooled to assess the impact of patient (demographics, cardiovascular risk factors, cardiovascular co-morbidities, Rutherford stages) and lesion-/procedure-related (location, occlusion, length, restenosis, calcification, subintimal crossing, post-dilatation, dissection, stenting) characteristics on LLL.

Drug Distribution and Basic Pharmacology of Paclitaxel/Resveratrol-Coated Balloon Catheters.

Purpose: To experimentally investigate a new homogenously paclitaxel/resveratrol-coated balloon catheter in terms of transport of the coating to the treated tissue and local effects including histology and functional tests.

Methods: Adherence of the coating to the balloon was explored by in vitro simulation of its passage to the lesion. Paclitaxel and resveratrol transfer to the vessel wall was investigated in porcine coronary and peripheral arteries.

A novel constrained, paclitaxel-coated angioplasty balloon catheter.

Aims: The study aimed to assess drug adherence, transfer to the vessel wall, tolerance and efficacy of a constrained angioplasty balloon coated with an excipient-enhanced paclitaxel coating (Chocolate coated balloon [CCB]) in the porcine model.

Methods And Results: Drug adherence was investigated in vitro. Drug transfer was evaluated in porcine arteries.

Novel Sirolimus-Coated Balloon Catheter: In Vivo Evaluation in a Porcine Coronary Model.

Background: Limus-eluting stents are dominating coronary interventions, although paclitaxel is the only drug on balloon catheters with proven inhibition of restenosis. Neointimal inhibition by limus-coated balloons has been shown in few animal studies, but data from randomized clinical trials are not available. The aim of the present preclinical studies was to achieve high and persistent sirolimus levels in the vessel wall after administration by a coated balloon.

Paclitaxel-Coated Balloons: Investigation of Drug Transfer in Healthy and Atherosclerotic Arteries - First Experimental Results in Rabbits at Low Inflation Pressure.

Purpose: Beyond antiproliferative properties, paclitaxel exhibits anti-inflammatory activity, which might be beneficial in the local treatment of nonocclusive coronary artery disease. Paclitaxel release and tissue concentrations after paclitaxel-coated balloon treatment using different pressures have not been investigated so far. The aim of the study was to investigate in an atherosclerotic rabbit model whether drug transfer from paclitaxel-coated balloons into the vessel wall is affected by the presence of atherosclerotic lesions and to which extent it depends on the inflation pressure used.

How does a drug-coated balloon work? Overview of coating techniques and their impact.

Background: According to current understanding the drug-coated balloon (DCB) carries a sufficient dose of an effective antineoplastic agent, i.e. paclitaxel, to the target lesion.

How does a drug-coated balloon work? Overview about coating technologies and their impact.

Background: According to current understanding the drug-coated balloon carries a sufficient dose of an effective antineoplastic agent, i.e. paclitaxel, to the target lesion.

A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial.

Background: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation.

Methods And Results: SB were coated with paclitaxel admixed with a specific excipient.

Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial.

Objectives: The purpose of this study was to evaluate the 5-year follow-up (FU) data of the THUNDER (Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries).

Background: The THUNDER trial was the first study to investigate the treatment of femoropopliteal arteries with a paclitaxel-coated balloon (PCB).

Methods: In 154 patients, femoropopliteal arteries were treated with PCB, with angioplasty with paclitaxel in contrast medium, or no paclitaxel (control).

Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis: the three-year results of the PEPCAD II ISR study.

Aims: Treatment of bare metal in-stent restenosis with the paclitaxel-coated balloon catheter based on the PACCOCATH® technology has yielded superior six-month angiographic and one-year clinical results compared to a paclitaxel-eluting stent. The three-year clinical follow-up is presented.

Methods And Results: One hundred and thirty-one patients with coronary bare metal in-stent restenosis (>70%, length: <22 mm, vessel diameter: 2.

High-grade, non-flow-limiting dissections do not negatively impact long-term outcome after paclitaxel-coated balloon angioplasty: an additional analysis from the THUNDER study.

Purpose: To investigate the impact of using paclitaxel-coated balloons (PCB) on outcome after post-angioplasty dissection in femoropopliteal arteries.

Methods: The angiograms obtained in the THUNDER study (ClinicalTrials.gov identifier NCT00156624) were analyzed to compare degrees of dissection and angiographic parameters between the control (uncoated balloons, n=43) and treatment (PCBs, n=43) groups before and after the intervention and at 6-month follow-up.

Inhibition of neo-intimal hyperplasia in porcine coronary arteries utilizing a novel paclitaxel-coated scoring balloon catheter.

Objective: Scoring balloons are particularly useful in the acute treatment of fibro-calcific, bifurcation and in-stent restenosis lesions but have not been shown to affect the restenosis rate. Conventional balloons coated with paclitaxel have recently been shown to reduce restenosis rates in certain lesion subsets, but are associated with suboptimal acute results. A novel paclitaxel-coated scoring balloon was developed to overcome these limitations.

Compassionate use of a paclitaxel coated balloon in patients with refractory recurrent coronary in-stent restenosis.

Objective: Treatment of coronary in-stent restenosis (ISR) remains a challenge in interventional cardiology, especially after drug eluting stent (DES)-ISR. Drug coated balloons (DCB) provide a new therapeutic option in the treatment of ISR. In patients with multiple layers of stents due to refractory ISR and exclusion criteria for revascularization by coronary artery bypass grafting, DCB may be a last therapy option.

Drug-coated balloons for restenosis prophylaxis.

Drug-coated balloons for restenosis prophylaxis provide a high local drug concentration with minimal or no systemic adverse effects. Their development was both delayed and facilitated by the introduction of drug-eluting stents: delayed because sustained release kinetics from stent platforms seemed to be essential and facilitated because prior experience with stents allowed selection of testing methods and drugs. Currently, a variety of drug-coated balloons are available, basically consisting of a coating containing paclitaxel at a dose of about 3 µg/mm² balloon surface, and different additives influencing the adherence and release of the drug, e.

Influence of a paclitaxel coated balloon in combination with a bare metal stent on restenosis and endothelial function: comparison with a drug eluting stent and a bare metal stent.

Aims: Different approaches of local intravascular drug delivery may influence endothelial and microvascular function. The aim of this trial was to study the influence of a paclitaxel coated balloon in combination with a bare metal stent (DCB + BMS) versus a bare metal stent (BMS) or a sirolimus-eluting stent (DES) on coronary restenosis and endothelial function.

Methods And Results: This prospective trial included 77 patients with coronary de novo lesions.

Treatment of a coronary bifurcation lesion with drug-coated balloons: lumen enlargement and plaque modification after 6 months.

We report a male with a coronary bifurcation lesion in the mid circumflex artery (CX). After predilatation, the lesion was treated with two drug-coated balloons (DCB). Primary success in the posterolateral branch was good; however the CX lesion had a residual stenosis including a non-flow-limiting type A dissection.