Drug-Coated Balloons for Restenosis Prophylaxis

Abstract

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??g/mm? balloon surface, and different additives influencing the adherence and release of the drug, e.?g., contrast agent, urea, or various amphiphilic compounds. The drug is almost completely released during a single inflation of 30???60 seconds. Studies in animals and several independent randomized clinical trials in coronary and peripheral arteries demonstrate effective reduction of neointimal proliferation, restenosis, and revascularization persisting for at?least 2 years or 5 years according to one study in coronary arteries. Drug-coated balloons are preferably used for treating coronary in-stent restenosis and de novo and restenotic lesions in peripheral vessels. No coating-related adverse events have been observed in clinical trials. Persistent efficacy may be explained by the long residence time of paclitaxel in tissue or inhibition of an essential first step in the chain of events leading to neointimal proliferation. Citation Format: ??Speck U., Scheller B., Hamm B. Drug-Coated Balloons for Restenosis Prophylaxis. Fortschr R?ntgenstr 2014; 186: 348???358

Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review

“…Thus, by using the best DES on the market, even better DES results would be expected, and the potential benefit of treatment with a DEB might diminish. While different drugs exist for DES, paclitaxel for now seems the preferred drug and is to date the only one used for DEB in the treatment of human coronary arteries [17]. Also, the future impact of using DEBs with drugs other than paclitaxel remains to be investigated [19, 20].…”

“…The coating differs with the contrast agent iopromide, the film-forming agent shellac, the amphiphilic butyryl trihexyl citrate, and urea being the most widely used. DEBs with other coatings are developed, but preclinical data are limited [17]. At present, eight different CE-approved DEBs are available and seemingly no class effect exists among them [11, 14, 18].…”

Forensic expert evaluation problems of early and late complications of interventional methods of treating coronary heart disease (systematic literature review)

“…Тем не менее существует вполне обоснованное мнение: несмотря на то что показания к имплантации стента расширены, а сама процедура оперативного вмешательства стала доступной [37,38], нет таких стентов, которые бы полностью решали проблему рестеноза в зоне его размещения [39,40].…”

Clinical risk factors for loss of stent primary patency in patients with chronic legs ischemia

“…Among such techniques are the use of: a) percutaneous angioplasty using plain old balloon angioplasty (POBA), drug-eluting balloons (DEB), and cutting balloons or cryoplasty; b) different scaffold techniques with the use of bare metal stents (BMS), drug-eluting stents (DES), cytokine-or growth-factor-eluting stents, covered stents, and bare or drug-eluting bioresorbable vascular scaffolding (BVS); as well as c) debulking techniques (atherectomy, and turbo-booster and excimer lasers). 1,[3][4][5][6][7][8][9][10][11][12] Few of these modern techniques are widely available, and many are also more aggressive and expensive. Therefore, they cannot be used for all patients.…”