Paclitaxel coated balloons for coronary artery interventions: A comprehensive review of preclinical and clinical data

Cortese, Bernardo; Bertoletti, Alessandra

doi:10.1016/j.ijcard.2011.08.855

Cited by 87 publications

(47 citation statements)

References 41 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, 1-year angioscopic evaluation in this study demonstrated that arterial healing had significantly progressed. The paclitaxel elutes for 56 days in Zilver PTX stent [1], and the drugeluting period is shorter than that of coronary DES except for the Endeavor stent [14]. While it has been reported that delayed arterial healing is secondary to the polymer in coronary DES [15], Zilver PTX stent does not include polymer in its structure.…”

Section: Discussionmentioning

confidence: 99%

Extensive arterial repair one year after paclitaxel-coated nitinol drug-eluting stent vs. bare-metal stent implantation in the superficial femoral artery

Ishihara

Iida

Awata

et al. 2014

Cardiovasc Interv and Ther

View full text Add to dashboard Cite

Arterial repair differences between paclitaxel-coated nitinol drug-eluting stent (DES) vs. bare-metal stent (BMS) up to 1 year after implantation in the superficial femoral artery (SFA) have not been well characterized. We compared angioscopic findings 1 year after implantation in the SFA of 22 DES in 18 patients and 12 BMS in 9 patients (follow-up period 354 ± 49 vs. 383 ± 81 days, P = 0.20). Neointimal coverage (NIC) was graded as: 0, stent struts exposed; 1, struts bulged into the lumen, although covered; 2, struts embedded by the neointima, but translucent; and 3, struts fully embedded and invisible. NIC was defined as heterogeneous when NIC grade variation was ≥1. Presence of thrombus and yellow plaques (YP) was assessed. Baseline patient and lesion characteristics were similar between the groups. In terms of procedural characteristics, stent diameter was smaller in DES than in BMS (6.5 ± 0.5 vs. 7.4 ± 0.8 mm, P = 0.0020). Both DES (grade 2 5 %, grade 3 95 %) and BMS (grade 3 100 %) revealed dominant NIC grades of 2 or 3 (P = 0.46), however, DES showed greater NIC heterogeneity than BMS (91 vs. 42 %, P = 0.004). Both thrombus and YP were more frequently observed in DES than in BMS (64 vs. 17 %, P = 0.001; 95 vs. 67 %, P = 0.042, respectively). In conclusion, although arterial repair was limited after DES implantation in the SFA, it was extensive at 1 year.

show abstract

Section: Discussionmentioning

confidence: 99%

Extensive arterial repair one year after paclitaxel-coated nitinol drug-eluting stent vs. bare-metal stent implantation in the superficial femoral artery

Ishihara

Iida

Awata

et al. 2014

Cardiovasc Interv and Ther

View full text Add to dashboard Cite

show abstract

“…It is, hence, necessary to integrate the PTX within the PVP coating after the crosslinking process by, for instance, an incorporation process as a pipetting process in order to guarantee a consistent PTX surface load of 3 µg/mm 2 , which has been shown to be safe and effective in non-clinical [21] and clinical studies [22,23]. The total DCB preparation process consequently involved (i) application of PVP via spray-coating, (ii) crosslinking of the deposited PVP coating via UV radiation at 254 nm, and (iii) incorporation of PTX via pipetting, which are all well-described and applied coating approaches for DCB [9]. Representative ESEM micrographs of DCB, coated via this strategy, reveal the successful integration of PTX crystals within the crosslinked hydrogel matrix (Figure 3).…”

Section: Development and In Vitro Characterization Of Pvp-coated Dcb mentioning

confidence: 99%

“…As PTX alone is very lipophilic and, hence, sticks to the balloon surface, transfer agents, as the mainly studied contrast agent iopromide [6], but also urea [7] and plasticizers [8], are applied in order to enhance the drug transfer capability. These are generally mixed in a varying content with the drug in an applicable solvent, and the resulting solutions/suspensions are deposited to the balloon surface by means of one of the numerous established coating approaches for vascular implants, mainly micropipetting, dip-coating, and spray-coating [9]. In contrast to DES coating designs, which mostly involve hydrophobic polymers as a drug reservoir in order to allow a sustained drug release over a long time period [10], described coating matrices used for DCB are rather hydrophilic and loose to guarantee spontaneous drug transfer upon balloon expansion.…”

Section: Introductionmentioning

confidence: 99%

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Petersen¹,

Minrath²,

Kaule³

et al. 2013

Coatings

View full text Add to dashboard Cite

Polyvinylpyrrolidone (PVP) is a conventionally applied hydrophilic lubricious coating on catheter-based cardiovascular devices, used in order to ease movement through the vasculature. Its use as drug reservoir and transfer agent on drug-coated balloons (DCB) is therefore extremely promising with regard to the simplification of its approval as a medical device. Here, we developed a PVP-based coating for DCB, containing paclitaxel (PTX) as a model drug, and studied the impact of crosslinking via UV radiation on drug stability, wash off, and transfer during simulated use in an in vitro vessel model. We showed that crosslinking was essential for coating stability and needed to be performed prior to PTX incorporation due to decreased drug bioavailability as a result of photodecomposition and/or involvement in vinylic polymerization with PVP under UV radiation. Moreover, the crosslinking time needed to be carefully controlled. While short radiation times did not provide enough coating stability, associated with high wash off rates during DCB insertion, long radiation times lowered drug transfer efficiency upon balloon expansion. A ten minutes radiation of PVP, however, combined a minimized drug wash off rate of 34% with an OPEN ACCESSCoatings 2013, 3 254 efficient drug transfer of 49%, underlining the high potential of photochemically crosslinked PVP as a coating matrix for DCB.

show abstract

“…60 Drug-eluting balloon has been proposed as a valid alternative to current DES, thanks to the ability to elute the antiproliferative drug without the longterm limitation of adding a further layer of struts. However, drug-eluting balloon are limited by the shorter therapeutic window of the antiproliferative drug, by a greater late lumen loss compared with new-generation DES, 61,62 and the frequent need for bail-out stenting because of the occurrence of flowlimiting vessel dissection. Moreover, as shown by the early results of the RIBS IV trial, the use of drug-eluting balloon is also associated with poorer clinical outcome when compared with EES for the treatment of DES ISR.…”

Section: Bvs In In-stent Restenosismentioning

confidence: 99%

Coronary Bioresorbable Vascular Scaffold Use in the Treatment of Coronary Artery Disease

Testa

Latib

Montone

et al. 2016

Circ: Cardiovascular Interventions

View full text Add to dashboard Cite

Bioresorbable vascular scaffolds (BVS) represent a promising novel approach for the treatment of coronary artery disease. BVS promise to address some of the well-known limitations of current drug-eluting stents, while providing a transient scaffolding of the vessel to prevent acute vessel closure/recoil. Drug elution by BVS prevents neointimal proliferation in a similar fashion to drug-eluting stents, and complete bioresorption is associated with late vessel lumen enlargement, plaque regression, and restoration of vasomotion. Based on the pathophysiological reasons and on the results derived from clinical studies, BVS are increasingly being used in clinical practice. The aim of this review is to provide an overview of the current evidence supporting the use of BVS in clinical practice. In particular, we will discuss the randomized controlled trials and registries evaluating the clinical outcome of these devices, with a special focus on their application in patients with acute coronary syndrome and in specific lesion subsets (bifurcations, chronic total occlusions, and in-stent restenosis).

show abstract

Paclitaxel coated balloons for coronary artery interventions: A comprehensive review of preclinical and clinical data

Cited by 87 publications

References 41 publications

Extensive arterial repair one year after paclitaxel-coated nitinol drug-eluting stent vs. bare-metal stent implantation in the superficial femoral artery

Extensive arterial repair one year after paclitaxel-coated nitinol drug-eluting stent vs. bare-metal stent implantation in the superficial femoral artery

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Coronary Bioresorbable Vascular Scaffold Use in the Treatment of Coronary Artery Disease

Contact Info

Product

Resources

About