First Experience With Drug-Eluting Balloons in Infrapopliteal Arteries

Schmidt, Andrej; Piorkowski, Michael; Werner, Martin; Ülrich, Matthias; Bausback, Yvonne; Bräunlich, Sven; Ick, Henrik; Schuster, Johannes; Botsios, Spiridon; Kruse, Hans-Joachim; Varcoe, Ramon L.; Scheinert, Dierk

doi:10.1016/j.jacc.2011.05.034

Cited by 191 publications

(133 citation statements)

References 6 publications

Supporting

Mentioning

125

Contrasting

Order By: Relevance

“…With inflation times of 30-60 sec, anti-proliferative drug (paclitaxel, sirolimus, and everolimus) levels have been shown to reach the adventitia of the artery, and remain detectable for weeks. The inhibition of the intimal hyperplastic response to arterial injury can potentially limit the amount of clinical restenosis [22]. This promising technology is not yet approved for use in the United States.…”

Section: Drug-coated Balloonsmentioning

confidence: 99%

SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use

Gray

Díaz‐Sandoval

Dieter

et al. 2014

Cathet Cardio Intervent

View full text Add to dashboard Cite

Intervention to treat infrapopliteal arterial disease can be challenging because the patients' comorbidities, the anatomic variables, and the limitations of our techniques. Clinical scenarios based on anatomic and clinical variables are presented. Recommendations regarding intervention (appropriate care, may be appropriate care, rarely appropriate care) are made based on best evidence. V C 2014 Wiley Periodicals, Inc.Key words: peripheral intervention; appropriate use; peripheral arterial disease INTRODUCTION Infrapopliteal (IP) arterial disease or "below the knee" arterial disease is commonly seen in patients with long-standing diabetes mellitus, chronic kidney disease, or the elderly. The most concerning manifestation of peripheral arterial disease (PAD) in these high risk patients is the development of critical limb ischemia (CLI: ischemic rest pain or ischemic ulcers). This arterial bed consists of relatively small caliber vessels, which are often calcified and associated with diffuse, multilevel disease. Due to the complexity of this patient population, their co-morbidities, and severity of vascular disease, there is a paucity of scientific evidence for the generalizability of percutaneous revascularization.In general, non-ambulatory patients with a short life expectancy and extensive necrosis or gangrene should undergo primary amputation. Ambulatory patients who are acceptable surgical candidates, expected to survive more than two years with a patent IP artery that provides direct flow to the foot (considered to be a good distal target), and an adequate autologous venous conduit should be considered for surgical bypass. Patients with significant medical co-morbidities that limit life expectancy, those at increased risk for surgery, those without an adequate distal target for bypass, or with poor venous conduit should be considered for an endovascular-first approach.This document was developed to guide physicians in clinical decision-making in the modern practical application of endovascular intervention for patients with IP arterial disease. ANATOMIC CONSIDERATIONSPatients with CLI typically have disease involving multiple levels (i.e., aorto-iliac, femoropopliteal (FP) and IP), but less than 10% of patients with CLI have hemodynamically significant disease in all three levels [1][2][3] (Table I). Infrainguinal disease (FP and IP) can be further subdivided into those with predominantly isolated IP disease ( 33%) and those with both FP and IP disease ( 67%) [4][5][6][7].Additional Supporting Information may be found in the online version of this article. Catheterization and Cardiovascular Interventions 84:539-545 (2014) Isolated IP disease is mainly seen in the elderly (>80-years old), diabetic, or dialysis-dependent patients [5]. These patients are at higher risk for amputation and have a shorter amputation-free survival compared to those with FP and IP disease (median amputation-free survival: 17 months (95% CI ¼ 9-24 m) versus 37 months (95% CI ¼ 28-44 m), P ¼ 0.001) [6]. Clinical and non-invasive cr...

show abstract

Section: Drug-coated Balloonsmentioning

confidence: 99%

SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use

Gray

Díaz‐Sandoval

Dieter

et al. 2014

Cathet Cardio Intervent

View full text Add to dashboard Cite

show abstract

“…Besides the study limitations, initial results are very promising. The Leipzig registry [18] included 104 patients (109 limbs) with critical limb ischaemia (82.6 %) or severe claudication (17.4 %) who were compared with an historical group treated with conventional angioplasty (PTA). Angiographic results showed the DEB group with a primary patency of 72.6 % at 3 months versus 31 % in the PTA group and a target lesion revascularisation of 17.3 % at 1 year versus 50 % for the PTA group.…”

Section: Drug-eluting Balloon (Deb)mentioning

confidence: 99%

Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era

Fanelli

Cannavale

2014

Eur Radiol

View full text Add to dashboard Cite

To analyse data comparing drug-eluting devices versus non-coated devices in the treatment of vascular disease in the infrapopliteal region. All data available in the literature (16 studies were included) comparing drug-eluting stents (DESs) and drug-eluting balloons (DEBs) versus bare-metal stents (BMSs) and conventional balloons were analysed. For each single study, primary and secondary endpoints were reported. As comparative studies between DEBs and DESs were not available, a technical evaluation of the advantages and disadvantages of both were also included. Besides the limitations of the published studies, all of them were reporting interesting results for the new generation devices (DEB and DES). DES: primary patency at 1 year comprised between 75.0 % and 86 %; target lesion revascularisation between 8.7 % and 13.8 %. DEB: primary patency comprised between 71 % and 84.6 % at 12 months; target lesion revascularisation between 15.3 % and 17.6 %. However, limb salvage rates were not always higher using a DEB rather than a standard percutaneous transluminal angioplasty (PTA); a clinical improvement for patients treated with DEB was demonstrated only in the Leipzig registry. On the basis of the results available, the drug-eluting devices produced better results. DEB can be considered the leading approach in below-the-knee disease. A comparative evaluation with DES is mandatory in the future. Key Points • We present data about advanced endovascular treatment of peripheral artery disease.• This provides an update on drug-eluting devices in infrapopliteal vascular disease.• Drug-eluting devices (DEB/DES) show promising results compared with traditional ones.Abbreviations BMS bare-metal stent DEB drug-eluting balloon DES drug-eluting stent PTA percutaneous transluminal angioplasty SFA superficial femoral artery

show abstract

“…To date, however, data on DEB for tibial revascularization are sparse. Current information on DEB technology for tibial revascularization are based on one series by Schmidt et al comparing DEB 26) with an historical comparison of POBA from a comparable study setting 12) and one single-center randomization (DEB versus POBA) performed by Liistro and colleagues. 8) Schmidt, et al were the first to publish first-experience data using DEB for tibial revascularization within a non-randomized single center trial.…”

Section: Pathophysiology Of Restenosis After Endovascular Therapy Of mentioning

confidence: 99%

“…8) Schmidt, et al were the first to publish first-experience data using DEB for tibial revascularization within a non-randomized single center trial. 26) A total of n = 104 patients (n = 109 limbs) with a mean tibial lesion length of 176 mm were analyzed undergoing tibial revascularization using DEB. After 3 months, restenosis defined as lumen compromise >50% on repeat angiography was 27.4%.…”

Section: Pathophysiology Of Restenosis After Endovascular Therapy Of mentioning

confidence: 99%

“…In comparison to the results from an earlier study at the same center using POBA for tibial revascularization, DEB was shown to reduce tibial restenosis in >60% (27.4% versus 68.8% ). 12,26) The first prospective and randomized comparison of DEB versus POBA for tibial revascularization was performed by Liistro, et al within the aforementioned DEBATE-BTK trial. 8) Thereby, a significant reduction in binary restenosis was observed after 12 months 27% versus 74% when comparing DES (n = 67) and POBA (n = 65).…”

Section: Pathophysiology Of Restenosis After Endovascular Therapy Of mentioning

confidence: 99%

See 1 more Smart Citation

Does Patency Matter in Patients with Critical Limb Ischemia Undergoing Endovascular Revascularization?

Baumann

Groechenig

Diehm

2014

Annals of Vascular Diseases

View full text Add to dashboard Cite

First Experience With Drug-Eluting Balloons in Infrapopliteal Arteries

Abstract: The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons. Randomized trials are required to show whether this difference will lead to improvement in clinical outcomes.

Cited by 191 publications

References 6 publications

SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use

SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use

Endovascular treatment of infrapopliteal arteries: angioplasty vs stent in the drug-eluting era

Does Patency Matter in Patients with Critical Limb Ischemia Undergoing Endovascular Revascularization?

Contact Info

Product

Resources

About