2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease

Micari, Antonio; Nerla, Roberto; Vadalà, G; Castriota, Fausto; Grattoni, Chiara; Liso, Armando; Russo, Paolo; Pantaleo, Paolo; Roscitano, Giuseppe; Cremonesi, Alberto

doi:10.1016/j.jcin.2017.01.028

Cited by 53 publications

(38 citation statements)

References 25 publications

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“…Published data support that DCBs lead to superior mid-and long-term clinical outcomes compared to PTA for FP lesions, [33][34][35] even if the evidence level for long real-world lesions is limited. [36][37][38] Even with DCB use, the need for stenting of some lesions remains. 39 The rates of provisional stenting among DCB treated FP lesions range from 4.1% to 27% in clinical trials and from 11% to 23.3% in two real-world studies from Italy and Germany respectively.…”

Section: Discussionmentioning

confidence: 99%

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

et al. 2018

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With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

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Section: Discussionmentioning

confidence: 99%

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

et al. 2018

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“…Compared with stents, deployments of balloons can leave a better condition for future possible repeated angioplasty. However, plain old balloon angioplasty seemingly performs not well, especially when used in long and complex lesions [1,2].…”

Section: Introductionmentioning

confidence: 99%

“…But most studies focus on the usage of DCBs in relatively short lesions in femoropopliteal arteries and have a relatively low proportion of chronic total occlusion (CTO) lesions [3][4][5][6][7]. The data of prognosis about long and occlusive lesions is very limited and insufficient [1,2,8]. Among published article, the result of CTO cohort in IN.PACT Global study by Gunnar Tepe et al is the only long CTO DCB outcomings, while there are several CTO studies about self-expandable stents [9].…”

Section: Introductionmentioning

confidence: 99%

“…With this objective of providing evidence of DCBs in long and occlusive lesions in femoropopliteal arteries, we herein report 1-year follow-up data of patients with CTO femoropopliteal lesions longer than 10 cm. Most past studies with long lesions have proportion of CTO ranging from 40 to 70% [1,2,10]. Although there have been IN.PACT CTO study result reported [9].…”

Section: Introductionmentioning

confidence: 99%

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One-year results of drug-coated balloons for long and occlusive Femoropopliteal artery disease: a single-arm trial

Lai

Zhang

Shao

et al. 2020

BMC Cardiovasc Disord

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Background: The performance of drug-coated balloons (DCBs) in femoropopliteal interventions has been proven through randomized trials in short lesions and lesions with relatively low proportion of occlusions. There is limited evidence of DCBs in long or occlusive lesions. This study is to investigate the efficacy of the paclitaxel-coated balloon for treatment of long and occlusive femoropopliteal arterial lesions. Methods: A single-arm trial including 44 femoropopliteal lesions (chronic total occlusion (CTO) plus > 10 cm) treated with DCBs was performed to collect data of average 1-year follow-up. Endpoints contain primary patency, target lesion revascularization (TLR), amelioration of the Rutherford classification, change of ankle brachial index (ABI) and major adverse events. Results: Technical success is 97.7% while device success is 100%. Mean lesion length was 186 ± 86.3 cm. Stent implantation was performed in 13.6%. Cumulative probability of primary patency was 78.8% ± 6.8% at 1 year while that of freedom from TLR was 91.4% ± 4.9%. Rutherford classification improved from average 3.3 ± 1.0 to 2.1 ± 1.4 (p < 0.001) at follow-up with a 72.7% amelioration rate. Ankle-branchial index changed from 0.33 ± 0.40 to 0.67 ± 0.37 (p = 0.002). No major adverse event was observed. Conclusion: These results suggest that it is safe and effective to treat long and totally occlusive femoropopliteal artery disease with DCBs. Further studies are demanded to confirm these results.

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“…However, after treatment with stents/balloons coated with paclitaxel alone, the restenosis incidence remains as high as 10%-20%; even worse, delayed thrombosis further limits the popularization of their application [7][8][9][10]. Therefore, further research and development on drug stents/balloons is needed.…”

Section: Introductionmentioning

confidence: 99%

Effect of Paclitaxel+Hirudin on the TLR4-MyD88 Signaling Pathway During Inflammatory Activation of Human Coronary Artery Smooth Muscle Cells and Mechanistic Analysis

Li¹,

Wang²,

Xu³

2018

Cell Physiol Biochem

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Background/Aims: Approximately 10%-20% of patients with acute cardiovascular disease who have received coronary intervention suffer restenosis and high inflammation. The stent compound paclitaxel+hirudin was prepared for the treatment of post-intervention restenosis. This study aimed to explore the anti-inflammatory and anti-restenosis mechanisms of paclitaxel+hirudin with regard to the TLR4/MyD88/NF-κB pathway. Methods: Human coronary artery smooth muscle cells (HCASMCs) at 4-6 generations after in vitro culture were used as a model. Lipopolysaccharide (LPS) was used as an inducer to maximally activate the TLR4/MyD88/NF-κB inflammation pathway. After MyD88 knockdown and selective blocking of MyD88 degradation with epoxomicin, the effects of paclitaxel+hirudin stenting on key sites of the TLR4/MyD88/NF-κB pathway were detected using ELISA, Q-PCR, and western blot analysis. Results: LPS at 1 μg/mL for 48 h was the optimal modeling condition for inflammatory activation of HCASMCs. Paclitaxel+hirudin inhibited the levels of key proteins and the gene expression, except for that of the MyD88 gene, of the TLR4-MyD88 pathway. The trend of the effect of paclitaxel+hirudin on the pathway proteins was similar to that of MyD88 knockdown. After epoxomicin intervention, the inhibitory effects of paclitaxel+hirudin on the key genes and proteins of the TLR4-MyD88 pathway were significantly weakened, which even reached pre-intervention levels. Paclitaxel+hirudin affected the MyD88 protein in a dosage-dependent manner. Conclusion: The paclitaxel+hirudin compound promotes MyD88 degradation in the TLR4/MyD88/NF-κB pathway to reduce the activity of TLR4 and NF-κB p65 and to weaken the LPS-initiated inflammatory reactions of IL-1β, IL-6, and TNF-α.

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2-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease

Abstract: PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease.

Cited by 53 publications

References 25 publications

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry

One-year results of drug-coated balloons for long and occlusive Femoropopliteal artery disease: a single-arm trial

Effect of Paclitaxel+Hirudin on the TLR4-MyD88 Signaling Pathway During Inflammatory Activation of Human Coronary Artery Smooth Muscle Cells and Mechanistic Analysis

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