Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter

Scheller, Bruno; Hehrlein, Christoph; Bocksch, Wolfgang; Rutsch, Wolfgang; Haghi, Dariush; Dietz, Ulrich; Böhm, Michael; Speck, Ulrich

doi:10.1056/nejmoa061254

Cited by 692 publications

(455 citation statements)

References 23 publications

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“…Specifically, DCB compared to DES show a significant benefit in the treatment of ISR,5, 6, 7, 8, 9, 10, 11, 12 and current guidelines recommend the use of DCB for patients with coronary ISR (class I, level of evidence A) 13. However, there are other potential indications such as coronary small vessel disease and bifurcation lesions 14, 15.…”

Section: Introductionmentioning

confidence: 99%

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Gilgen

Farah

Scheller

et al. 2018

Clinical Cardiology

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The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug‐eluting stents (DES) have limited efficacy due to increased rates of instent‐restenosis, mainly caused by late lumen loss. Drug‐coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten‐Effektivitäts Trial: Drug‐Coated Balloons vs. Drug‐Eluting Stents in Small Vessel Interventions (BASKET‐SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty‐eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target‐vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long‐term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long‐term safety and efficacy for the treatment of SVD in a large all‐comer population.

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Section: Introductionmentioning

confidence: 99%

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Gilgen

Farah

Scheller

et al. 2018

Clinical Cardiology

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“…PTX has been administered with a great success in the treatment of in-stent restenosis [1][2][3]. Being biodegradable and biocompatible, PLGA is widely used for delivery of PTX and other drugs coated on stents [1,[4][5][6].…”

Section: Introductionmentioning

confidence: 99%

Paclitaxel distribution in poly(ethylene glycol)/poly(lactide-co-glycolic acid) blends and its release visualized by coherent anti-Stokes Raman scattering microscopy

Kang¹,

Robinson²,

Park³

et al. 2007

Journal of Controlled Release

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Mechanisms underlying the release of paclitaxel (PTX) from poly(ethylene glycol)/poly(lactic-coglycolic acid) (PEG/PLGA) blends were investigated by coherent anti-Stokes Raman scattering (CARS) microscopy. PLGA, PEG, and PTX were selectively imaged by using the resonant CARS signal from the CH 3 , CH 2 , and aromatic CH stretch vibrations, respectively. Phase segregation was observed in PLGA films containing 10 to 40 wt.% PEG in the absence of PTX loading. The PEG phase existed in the form of crystalline fibers in the (8:2, weight ratio) and (7:3) PLGA/PEG films. CARS observation indicated that PTX preferentially partitioned into the PEG domains in the (9:1) and (8:2) PLGA/PTX films, but exhibited a uniform mixing with both PLGA and PEG in the (7:3) PLGA/PEG film. The solid dispersion of PTX into PEG domains was attributed to a strong interaction between PTX and PEG, supported by the disappearance of PEG crystallization in the PTX-loaded PLGA/PEG film evidenced through X-ray diffraction analysis. PTX release was induced by exposing the film to an aqueous solution and monitored in real time by CARS and two-photon fluorescence microscopy. Fast dissolution of both PEG and PTX was observed at the film surface. Upon infiltration of water into the film, the PEG domains rearranged into ring structures enriched by both PTX and PEG. The CARS data provided a visual evidence explaining the accelerated burst release followed by more sustained release of PTX from the PLGA/PEG films as measured by HPLC.

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“…An angiographic contrast medium enriched with paclitaxel was found to be associated with an inhibition of neointimal proliferation four weeks after the intervention (30,31). Another interesting approach derives from the possibility of coating with antiproliferative drugs the balloons for angioplasty (32)(33)(34).…”

Section: Discussionmentioning

confidence: 99%

Effect of a novel drug-eluted balloon coated with Genistein before stent implantation in porcine coronary arteries

et al. 2008

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This is an author version of the contribution published on: Questa è la versione dell'autore dell'opera: [Effect of a novel drug-eluted balloon coated with genistein before stent implantation in porcine coronary arteries.Sheiban I, Anselmino M, Moretti C, Biondi-Zoccai G, Galloni M, Vignolini C, Mattoni M, Sciuto F, Omedè P, Trevi GP. Clin Res Cardiol. 2008 Dec;97(12):891-8. doi: 10.1007/s00392-008-0705-2.] The definitive version is available at: La versione definitiva è disponibile alla URL: [http://link.springer.com/article/10.1007%2Fs00392-008-0705-2] Phone: +39-011-6334446. Fax: +39-0116967053. Email: isheiban@yahoo.com 3 Background. The major drawback of stent implantation in native human coronary vessels is the occurrence of restenosis. Drug-eluting stents significantly reduce restenosis after percutaneous coronary intervention (PCI), but may be associated with persistent local inflammation involved in the restenosis mechanisms. In this setting coating coronary devices with anti-inflammatory agents represents an intriguing alternative to stent-based local drug delivery. The aim of the present study was to test in a porcine model the safety and efficacy of a novel Genistein-eluting balloon preceding coronary stenting.Design. Female piglets underwent PCI in a randomized fashion with either a Genistein-eluting or a standard balloon angioplasty, followed in all vessels by bare-metal stent implantation. Pigs were sacrificed at different time points to appraise safety (i.e. endothelialization) and efficacy (i.e. antiinflammatory and anti-proliferative effects): 1, 4, and 6-8 weeks following PCI.Results. Overall analysis was conducted on 14 piglets. Twenty-five bare-metal stents were implanted preceded by angioplasty with a conventional balloon in 13 vessels and by the Genistein-eluted balloon in 12. No untoward effects were reported in either group. Healing and endothelialization appeared universal within four weeks. The Genistein-eluted balloon group disclosed a significant reduction, at four weeks from implantation, of the peri-stent inflammatory cells count (mononucleocytes 39±32 vs.96±29 per square millimetre, p=0.019. This effect did not clearly translate into a trend towards a reduced neointimal hyperplasia at six-eight weeks (0.13±0.11 vs. 0.14±0.09, p=0.835).Conclusion. This study provides the first in vivo demonstration of the anti-inflammatory effects of a Genistein-eluting balloon in PCI, warranting further research including the combination of a Genisteineluting balloon with standard drug-eluting stent.4

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Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter

Cited by 692 publications

References 23 publications

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Paclitaxel distribution in poly(ethylene glycol)/poly(lactide-co-glycolic acid) blends and its release visualized by coherent anti-Stokes Raman scattering microscopy

Effect of a novel drug-eluted balloon coated with Genistein before stent implantation in porcine coronary arteries

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