A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated Balloon Versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis

Xu, Bo; Gao, Runlin; Wang, Jianan; Yang, Yuejin; Chen, Shao‐Liang; Liu, Bin; Chen, Fang; Li, Zhanquan; Han, Yaling; Fu, Guosheng; Zhao, Yelin; Ge, Junbo; Investigators, Pepcad China Isr Trial

doi:10.1016/j.jcin.2013.08.011

Cited by 136 publications

(94 citation statements)

References 17 publications

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“…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the safety and feasibility of lutonix PCB in BMS‐ISR, and a certain biological effect as indicated by very low LLL (unpublished data, presented at TCT 2010 by Laura Mauri, MD). Recently, several clinical studies have shown the clinical efficacy and safety of PCB also in coronary DES‐ISR 21, 22, 23.…”

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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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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“…1) However, imaging findings of the drug covering the neointimal plaque immediately after treatment of ISR by DCB, and during follow-up, have only been described in a few reports. Herein, we report the use of coronary angioscopy and OCT to confirm drug coating of neointimal plaque at the ISR lesion after paclitaxel DCB angioplasty at baseline and during follow-up.…”

Section: T He Drug-coated Balloon (Dcb) Is a Device That Is Usedmentioning

confidence: 99%

Serial Observations of In-Stent Restenosis Treated With Drug-Coated Balloon Angioplasty by Optical Coherence Tomography and Coronary Angioscopy

2017

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SummaryThe drug-coated balloon (DCB) is a device that is used to reduce the risk of stent re-implantation in patients with in-stent restenosis (ISR). However, imaging findings of the drug covering the neointimal plaque immediately after treatment of ISR by DCB, and during follow-up, have only been discussed in a few reports. Herein, we describe the use of optical coherence tomography (OCT) and angioscopy to evaluate ISR before and after treatment with DCB, and during the follow-up period in 3 patients. The patients developed critical ISR during the follow-up period after drug-eluting stent (DES) implantation. The patients included a 70-year-old woman, a 70-year-old man, and an 80-year-old man. These imaging modalities provided data about the various etiologies of ISR, and about the efficacy of DCB angioplasty. Based on the findings of the intracoronary images in these 3 cases, we concluded that DCB might not only inhibit neointimal proliferation, but also reduce neointimal volume and lead to changes in in-stent neointimal morphology. (Int Heart J 2017; 58: 134-139)

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“…Eight studies [19][20][21][22][23][24][25][26] with 326 TVR over 1718 patient-years follow-up contributed to the network for DES-ISR and compared 5 different treatments ( Figure 7A). As shown in Figure 7B, BA was inferior to all 4 drug-eluting treatments.…”

Section: Drug-eluting Stent Isrmentioning

confidence: 99%

Efficacy of Various Percutaneous Interventions for In-Stent Restenosis

Sethi

Malhotra

Singh

et al. 2015

Circ: Cardiovascular Interventions

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Background— In-stent restenosis (ISR) remains a difficult problem in interventional cardiology. The relative efficacy and safety of available interventions is not clear. We aimed to perform a network meta-analysis using both direct evidence and indirect evidence to compare all available interventions. Methods and Results— We systematically searched electronic databases for randomized trials comparing ≥2 treatments for ISR. A network meta-analysis was performed using a Bayesian approach. Eleven treatments were compared in 31 studies with 8157 patient-years follow-up. Compared with balloon angioplasty, everolimus-eluting stent (hazard ratio [95% credibility interval], 0.13 [0.048–0.35]), paclitaxel-eluting balloon (0.32 [0.20–0.49]), paclitaxel-eluting cutting balloon (0.054 [0.0017–0.5]), paclitaxel-eluting stent (0.39 [0.24–0.62]), and sirolimus-eluting stent (0.32 [0.18–0.50]) are associated with lower target vessel revascularization. Balloon angioplasty is not different from cutting balloon (0.73 [0.31–1.5]), excimer laser (0.89 [0.29–2.7]), rotational atherectomy (0.96 [0.53–1.7]), and vascular brachytherapy (0.60 [0.35–1.0]). In drug-eluting stent ISR, balloon angioplasty was inferior to everolimus-eluting stent (0.19 [0.049–0.76]), paclitaxel-eluting balloon (0.43 [0.18–0.80]), paclitaxel-eluting stent (0.35 [0.13–0.76]), and sirolimus-eluting stent (0.36 [0.11–0.86]) for target vessel revascularization. There was no difference between treatments in probable or definitive stent thrombosis. The results of binary restenosis and target lesion revascularization were similar. Paclitaxel-eluting cutting balloon, everolimus-eluting stent, and paclitaxel-eluting balloon have the highest probability of being in the top 3 treatments based on low target lesion revascularization, but there was no statistical significant difference between them. Conclusions— Balloon angioplasty is inferior to all drug-eluting treatments for ISR, including drug-eluting stent ISR. Drug-eluting stent, particularly everolimus-eluting stent, or paclitaxel-eluting cutting balloon and paclitaxel-eluting balloon should be preferred for treating ISR.

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A Prospective, Multicenter, Randomized Trial of Paclitaxel-Coated Balloon Versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis

Cited by 136 publications

References 17 publications

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

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

Serial Observations of In-Stent Restenosis Treated With Drug-Coated Balloon Angioplasty by Optical Coherence Tomography and Coronary Angioscopy

Efficacy of Various Percutaneous Interventions for In-Stent Restenosis

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