Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group

Kleber, Franz X.; Rittger, Harald; Bonaventura, Klaus; Zeymer, Uwe; Wöhrle, Jochen; Jeger, Raban; Levenson, Benny; Möbius‐Winkler, Sven; Bruch, Leonhard; Fischer, Dieter; Hengstenberg, Christian; Pörner, Tudor; Mathey, D; Scheller, Bruno

doi:10.1007/s00392-013-0609-7

Cited by 167 publications

(147 citation statements)

References 69 publications

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“…11 Furthermore, the use of PCB as standalone therapy represents the most rigorous approach to establish the concept of leaving nothing behind. 12,13 However, in coronary artery disease, the combination of PCB and baremetal stents turned out to be inferior to current generation limus-eluting stents. [14][15][16] Furthermore, conflicting data have been reported for PCB in the treatment of below the knee disease.…”

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confidence: 99%

Novel Sirolimus–Coated Balloon Catheter

Clever

Peters

Calisse

et al. 2016

Circ: Cardiovascular Interventions

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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. Methods and Results-Different coating formulations and doses were studied in the porcine coronary model to investigate sirolimus tissue levels at different time points as well as efficacy at 1 month using quantitative coronary angiography and histomorphometry. Loss of the selected coating in the valve, guiding catheter, and blood was low (2±14% of dose). Acute drug transfer to the vessel wall was 14.4±4.6% with the crystalline coating, whereas the amorphous coatings were less effective in this respect. Persistence of sirolimus in the vessel wall until 1 month was 40% to 50% of the transferred drug. At 1-month follow-up, a modest but significant reduction of neointimal growth was demonstrated in a dose range from 4 μg/mm 2 to 2×7 μg/mm 2 , for example, maximum neointimal thickness of 0.38±0.13 versus 0.65±0.21 mm in the uncoated control group. Conclusions-Various Methods Research StrategyA variety of sirolimus balloon-coating formulations were prepared and tested with the primary aim of achieving high transfer rates to the arterial wall and long-lasting persistence in the vessel wall because of increased crystal formation. Other important properties were minimal loss of the drug on the way to the treatment site, inhibition of injury-induced neointimal proliferation, and good local and systemic tolerance. Materials and Coating of BalloonsConventional percutaneous transluminal coronary angioplasty balloon catheters (SeQuent [Neo], B. Braun Melsungen AG, Berlin, Germany) were coated using different coating formulations, coating procedures, and dosages (Table 1; Figure 1). Sirolimus was produced according to Good Manufacturing Practice by Euticals S.p.A., Site of Rozzano, Italy; solvents were USP or analytic grade. Coating was performed in a dose range of ≤7-μg sirolimus per mm 2 balloon surface by dispersing a precisely defined volume of organic solvents containing sirolimus with different matrix-forming additives on the balloons.The different coating procedures resulted in different physicochemical properties in terms of amorphous and crystalline characteristics.After coating, the catheters were left to dry for at least 24 hours at room temperature before use or further processing. For some of the experiments, bare stainless steel stents (B. Braun AG, Melsungen. Germany) were mounted onto balloons using a hand crimper HH100-101 (Machine Solutions, Flagstaff, AZ). Balloon catheters used for determination of sirolimus loss in blood on the way to the coronary artery were left without stents. Balloon catheters used for the animal studies were EO sterilized b...

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Novel Sirolimus–Coated Balloon Catheter

Clever

Peters

Calisse

et al. 2016

Circ: Cardiovascular Interventions

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“…Overall results were at least comparable with DES treatment. In the larger subgroup of patients treated according to the German consensus recommendations [13,19] we found unexpected low restenosis and reocclusion rates exceeding the results described with DES. Improvement of angina was impressive as well.…”

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confidence: 73%

“…In native coronary artery lesions and in-stent restenosis (ISR) this approach leads to an extremely low restenosis and an almost zero percent thrombosis rate [10][11][12], thus obviating the need for prolonged dual antiplatelet therapy (DAPT). Four weeks of DAPT is sufficient after DCB [13] compared to six to twelve months after DES [14]. Also, a DCB approach without foreign body implantation gives the vessel the opportunity to remodel positively.…”

Section: Commentarymentioning

confidence: 97%

Why Treat Chronic Total Occlusion without Stents? - A Short Comment

Köln¹,

Kleber²

2017

J Clin Exp Cardiolog

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The treatment of chronic total occlusions is complex and associated with several risks and problems. Among therapeutic options including bypass surgery and medical therapy PCI represents an important strategy. PCI with stents, however, has limitations in such lesions due to characteristics like lesion length, unknown reference diameter and delayed stent coverage. Drug coated balloons have shown promising properties to overcome some of those limitations: They promote positive vessel remodeling and have a minimal thrombosis rate. In a first multicenter study it has been shown that drug coated balloons in proper indications and applied with appropriate technique might become a new treatment option for patients with chronic total occlusions. CommentaryChronic total occlusions (CTO) of coronary arteries have been a focus point of research in interventional cardiology for several years. Recanalization, balloon dilatation and implantation of drug eluting stents (DES) are recognized treatment options for patients with symptomatic CTO. Recanalization of CTO ranks among the most complicated percutaneous coronary interventions (PCI) and the procedures are to be performed by well-equipped and experienced centers. During the last decades the procedural success rates increased due to improved technical equipment and increasing operator experience [1,2].It is still uncertain whether PCI is the optimal treatment method for CTO and it competes with coronary artery bypass grafts (CABG) and medical treatment. Large retrospective registries have shown a reduction of adverse events and a clinical improvement after successful CTO PCI [3,4]. The only recently conducted DECISION-CTO trial [5] was the first large randomized controlled trial (RCT) to compare different treatment modalities for CTO. It failed to show a significant difference between PCI and optimal medical therapy. In general CTO PCI should only be considered for symptomatic patients with viable myocardium and no contraindications for PCI.Further research and new strategies might improve CTO PCI in the future, amongst them bioresorbable vascular scaffolds and drug coated balloons (DCB). CTO vessels usually have long lesions to be treated [6], have often an unknown vascular diameter and might have a number of side branches, often not readily recognizable beforehand.Thus, there are several characteristics of CTO that call for a stent free PCI approach. In the attempt of covering the lesion completely frequently more than 5 cm of the affected vessel have to be stented during CTO PCI. DES of such lengths has shown an increased risk of diffuse restenosis and other stent-linked complications [7]. The selection of a proper stent size can be difficult due to the lack of a reference diameter. An inappropriate stent size however can lead to either extensive vessel damage or to secondary malapposition. Also side branches might be occluded.In addition, even in comparison with similar long non-CTO lesions a delayed coverage of stent struts has been observed in CTO after DES imp...

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“…Clinically, the safety and efficacy profile of PCB was originally tested in the setting of coronary BMS‐ISR 3, 19, 20. In PERVIDEO registry study, 6‐month follow‐up showed the safety and feasibility of lutonix PCB in BMS‐ISR, and a certain biological effect as indicated by very low LLL (unpublished data, presented at TCT 2010 by Laura Mauri, MD).…”

Section: Discussionmentioning

confidence: 99%

Biological effect on drug distribution and vascular healing via paclitaxel‐coated balloon technology in drug eluting stent restenosis swine model

Li¹,

Téllez²,

Rousselle³

et al. 2015

Cathet Cardio Intervent

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ObjectivesTo evaluate the biological effect of a paclitaxel‐coated balloon (PCB) technology on vascular drug distribution and healing in drug eluting stent restenosis (DES‐ISR) swine model.BackgroundThe mechanism of action and healing response via PCB technology in DES‐ISR is not completely understood.MethodsA total of 27 bare metal stents were implanted in coronary arteries and 30 days later the in‐stent restenosis was treated with PCB. Treated segments were harvested at 1 hr, 14 days and 30 days post treatment for the pharmacokinetic analysis. In addition, 24 DES were implanted in coronary arteries for 30 days, then all DES‐ISRs were treated with either PCB (n = 12) or uncoated balloon (n = 12). At day 60, vessels were harvested for histology following angiography and optical coherence tomography (OCT).ResultsThe paclitaxel level in neointimal tissue was about 18 times higher (P = 0.0004) at 1 hr C max, and retained about five times higher (P = 0.008) at day 60 than that in vessel wall. A homogenous distribution of paclitaxel in ISR was demonstrated by using fluorescently labeled paclitaxel. Notably, in DES‐ISR, both termination OCT and quantitative coronary angioplasty showed a significant neointimal reduction and less late lumen loss (P = 0.05 and P = 0.03, respectively) post PCB versus post uncoated balloon. The PES‐ISR + PCB group displayed higher levels of peri‐strut inflammation and fibrin scores compared to the ‐limus DES‐ISR + PCB group.ConclusionsIn ISR, paclitaxel is primarily deposited in neointimal tissue and effectively retained over time following PCB use. Despite the presence of metallic struts, a uniform distribution was characterized. PCB demonstrated an equivalent biological effect in DES‐ISR without significantly increasing inflammation. © 2015 Wiley Periodicals, Inc.

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Drug-coated balloons for treatment of coronary artery disease: updated recommendations from a consensus group

Abstract: DCB allow for local drug delivery in endovascular therapy leaving no permanent implant behind.

Cited by 167 publications

References 69 publications

Novel Sirolimus–Coated Balloon Catheter

Novel Sirolimus–Coated Balloon Catheter

Why Treat Chronic Total Occlusion without Stents? - A Short Comment

Biological effect on drug distribution and vascular healing via paclitaxel‐coated balloon technology in drug eluting stent restenosis swine model

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