Drug-Coated Balloons for Complex Femoropopliteal Lesions

Schmidt, Andrej; Piorkowski, Michael; Görner, Henrik; Steiner, Sabine; Bausback, Yvonne; Scheinert, Susanne; Banning-Eichenseer, Ursula; Staab, Holger; Branzan, Daniela; Varcoe, Ramon L.; Scheinert, Dierk

doi:10.1016/j.jcin.2015.12.267

Cited by 139 publications

(152 citation statements)

References 25 publications

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“…In the present 37 patients undergoing re-EVT, the 2-year primary patency was 58%, which was similar to a previous report. 7 As well, we showed that the results of POBA or BNS for DCB restenosis were discouraging for either ISR or non-ISR lesions. The rates of freedom from binary restenosis and CD-TLR at 1 year were 14% and 38%, respectively.…”

Section: Resultsmentioning

confidence: 64%

“…7 Re-EVT in 30% of the participants in Schmidt's study was necessary to maintain vessel patency, but the outcome and treatment strategy in cases of re-EVT have not been reported. 7 Iida et al reported their 1-year results of re-EVT for DES-ISR of the FP artery. They showed a higher rate of restenosis after reintervention regardless of focal, diffuse or occluded lesions (53%, 74%, and 78%, respectively).…”

Section: Resultsmentioning

confidence: 99%

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Clinical Outcomes of Repetition of Drug-Coated Balloon for Femoropopliteal Restenosis After Drug-Coated Balloon Treatment

Jang

Chou

Juang

et al. 2017

Circ J

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evaluated the efficacy and outcome of repetition of DCB for DCB restenosis during a 45-month follow-up. Methods Study PopulationThe subjects for this study were derived from the Tzuchi Registry of ENDovascular Intervention for Peripheral Artery Disease (TRENDPAD), which is an ongoing, prospective, physician-initiated, single-center observational registry of patients who underwent EVT for lower limb ischemia that was started in July 2005. This database was searched to identify symptomatic patients who underwent DCB angioplasty for FP disease between March 2013 and September 2014. The details of patient enrollment and exclusion are described elsewhere. 10 The local ethics committee and institutional review board approved this study (IRB E ndovascular therapy (EVT) is the treatment of choice for most patients with symptomatic peripheral arterial disease (PAD). 1 Plain old balloon angioplasty (POBA) with or without stent placement in long femoropopliteal (FP) lesions is associated with high rates of restenosis. 2 Several randomized controlled trials have shown promising results using drug-coated balloons (DCB) without the requirement of metallic implants to treat symptomatic FP disease. 3-6 However, Schmidt et al reported 2-year results of DCB for complex FP lesions with a higher rate of late catch-up restenosis. 7 Iida et al reported that up to 50% of cases required repeated EVT (re-EVT) more than once during the 2-year follow-up among patients who had reintervention for drug-eluting stent (DES) restenosis. 8 Although DCB is effective in the treatment of FP in-stent restenosis (ISR), 9 information regarding the optimal strategy for FP DCB restenosis is lacking. In this study, we

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Section: Resultsmentioning

confidence: 64%

Section: Resultsmentioning

confidence: 99%

Clinical Outcomes of Repetition of Drug-Coated Balloon for Femoropopliteal Restenosis After Drug-Coated Balloon Treatment

Jang

Chou

Juang

et al. 2017

Circ J

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“…[4][5][6] In addition to improved efficacy in terms of improvement of symptoms, time free from reintervention, and reductions in amputation rates, studies have also shown that the procedures have similar levels of safety, which is understandable considering the similar techniques employed.…”

Section: Discussionmentioning

confidence: 99%

O uso do balão com paclitaxel no tratamento da reestenose intra-stent no segmento fêmoro-poplíteo

Oliveira¹,

Peclat²,

Barreto³

et al. 2017

J. vasc. bras.

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Background: In-stent restenosis due to myointimal hyperplasia after angioplasty is common and limits long-term patency. Treatments using balloons coated with antiproliferative drugs may offer an alternative option for this pathology. Objectives: To demonstrate the efficacy and complications (death, major amputations, etc.) of drug-coated balloons for treatment of in-stent restenosis in femoropopliteal segments. Methods: This was a retrospective cohort study of 32 consecutive patients treated between 2012 and 2016 who underwent treatment to correct in-stent restenosis in the femoropopliteal segment using paclitaxel-coated balloons. The success rate was measured in terms of technical success and restenosis of less than 50% on Doppler ultrasonography at 30, 90, and 180 days after the procedure. Results: Four patients (12.5%) exhibited restenosis greater than 50%, one (3.1%) after 90 days and three (9.4%) after 180 days, equating to a success rate of 87.5% of procedures, and by 180 days all patients experienced improvement or cessation of the signs and/or symptoms they had presented prior to the procedure. There were no deaths and complications occurred in just 2 cases in the immediate postoperative period. Conclusions: Short-term results are promising, with reductions in the magnitude of restenosis and a low rate of complications. Further studies are needed that can demonstrate the long-term effects and the economic impacts in comparison to other procedures.

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“…Up to date, it is the long lesions and chronic total occlusions of the femoropopliteal artery that continue to represent a major challenge for currently available endovascular treatment approaches. In case of intermediate and long femoropopliteal lesions, stenting with conventional or drug-eluting (long) nitinol stents ("full metal jackets") did not show convincing patency rates, but was associated with relevant in-stent-restenosis rates [6][7][8]. Therefore, on the one hand, non-stent-based approaches ("leave nothing behind" strategy) would be particularly desirable for long lesions.…”

Section: Discussionmentioning

confidence: 99%

Multiple stent delivery system Multi-LOC, a new technology for spot-stenting of the femoropopliteal artery – proof of concept study in a preclinical large animal model

Sigl

Dudeck

Jung³

et al. 2017

Vasa

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Summary:Background: A new stent system was studied in a porcine model to evaluate its feasibility for spot-stenting of the femoropopliteal artery. Materials and methods: In a preliminary study in a single pig, handling and mechanical features of the novel multiple stent delivery system were tested. The Multi-LOC system demonstrated great feasibility regarding its pushability, trackability, and crossability. Excellent visibility of the individual stents allowed exact anatomically controlled implantation. In our main study, four to fi ve short Multi-LOC stents (13 mm long) were implanted into the femoropopliteal arteries of six domestic pigs and long (60 to 100 mm) self-expandable nitinol stents were implanted into the same target vessel contralaterally to allow for intraindividual comparison. After four weeks survival under dual antiplatelet treatment, control angiography was performed. The animals were euthanized, stented vessels were explanted, and histologic sections were examined for the presence of neointimal formation. Results: Multi-LOC stents demonstrated no occlusion of the femoropopliteal axis (0 vs. 1 occlusion distal to a control stent), no stent fractures (0 out of 26 vs. 2 out of 6 control stents), and lower percentage diameter stenosis (0.564 ± 0.056 vs. 0.712 ± 0.089; p = 0.008) and length of stenosis (19.715 ± 5.225 vs. 39.397 ± 11.182; p = 0.007) compared to a standard control stent, which was similar in total length to the multiple stented artery segment. Histological examination confi rmed myointimal hyperplasia underlying in-stent stenosis. Conclusions: The multiple stent delivery system was studied in a porcine model, which demonstrated its feasibility. Preclinical experience revealed favourable results concerning stent fracture, restenosis, and patency of spot-stented femoropopliteal arteries.

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Drug-Coated Balloons for Complex Femoropopliteal Lesions

Abstract: These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.

Cited by 139 publications

References 25 publications

Clinical Outcomes of Repetition of Drug-Coated Balloon for Femoropopliteal Restenosis After Drug-Coated Balloon Treatment

Clinical Outcomes of Repetition of Drug-Coated Balloon for Femoropopliteal Restenosis After Drug-Coated Balloon Treatment

O uso do balão com paclitaxel no tratamento da reestenose intra-stent no segmento fêmoro-poplíteo

Multiple stent delivery system Multi-LOC, a new technology for spot-stenting of the femoropopliteal artery – proof of concept study in a preclinical large animal model

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