<b>Lower Limb Multilevel Treatment With Drug-Eluting Balloons:</b>6-Month Results From the DEBELLUM Randomized Trial

Fanelli, Fabrizio; Cannavale, Alessandro; Boatta, Emanuele; Corona, Mario; Lucatelli, Pierleone; Wlderk, Andrea; Cirelli, Carlo; Salvatori, Filippo Maria

doi:10.1583/jevt-12-3926mr.1

Cited by 121 publications

(98 citation statements)

References 20 publications

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“…Patients were randomised between Medtronic In.Pact DEB and conventional angioplasty balloon (PTA). The preliminary 1-year results on the below-the-knee lesions confirmed a better outcome for DEB in terms of late lumen loss (0.66±0.9 mm DEB vs 1.69± 1.5 mm PTA; P<0.05), target lesion revascularisation (15.3 % DEB vs 47.0 % PTA; P<0.05), and primary patency (84.6 % DEB vs 41.1 % PTA; P<0.05) [21]. However, major adverse events (major and minor amputation, thrombosis, death) did not different significantly in the two groups because of the limited number of lesions and patients involved.…”

Section: Drug-eluting Balloon (Deb)mentioning

confidence: 66%

“…One of the most recent studies is the DEBELLUM (Lower Limb Multilevel Treatment With Drug-Eluting Balloons) trial [20], which analysed 50 patients with femoropopliteal, infrainguinal and multilevel (concomitant femoropopliteal and below-the-knee) atherosclerotic disease. Patients were randomised between Medtronic In.Pact DEB and conventional angioplasty balloon (PTA).…”

Section: Drug-eluting Balloon (Deb)mentioning

confidence: 99%

“…-Primary patency is currently between 73 % (DEBATE [22]) and 84.6 % at 12 months (DEBELLUM [21]). -Target lesion revascularisation is between 15.3 % (DEBELLUM [21]) and 17.6 % (Leipzig Registry [18]).…”

Section: Drug-eluting Balloon (Deb)mentioning

confidence: 99%

“…-Target lesion revascularisation is between 15.3 % (DEBELLUM [21]) and 17.6 % (Leipzig Registry [18]). …”

Section: Drug-eluting Balloon (Deb)mentioning

confidence: 99%

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

Fanelli

Cannavale

2014

Eur Radiol

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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

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Section: Drug-eluting Balloon (Deb)mentioning

confidence: 66%

Section: Drug-eluting Balloon (Deb)mentioning

confidence: 99%

Section: Drug-eluting Balloon (Deb)mentioning

confidence: 99%

“…-Target lesion revascularisation is between 15.3 % (DEBELLUM [21]) and 17.6 % (Leipzig Registry [18]). …”

Section: Drug-eluting Balloon (Deb)mentioning

confidence: 99%

See 2 more Smart Citations

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

Fanelli

Cannavale

2014

Eur Radiol

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“…However, these nitinol stents are mostly used for other territories such as cardiovascular and biliary tree indications. Antiproliferative drugs are used in cardiovascular indications to avoid restenosis 11,12 , but experience on the airway is limited.…”

Section: Introductionmentioning

confidence: 99%

Tracheal Self-Expandable Metallic Stents: A Comparative Study of Three Different Stents in a Rabbit Model

Serrano

Lostalé

Rodríguez-Panadero

et al. 2016

Archivos de Bronconeumología (English Edition)

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Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs

Kayssi

Al-Atassi

Oreopoulos

et al. 2016

Cochrane Database of Systematic Reviews

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Based on a meta-analysis of 11 trials with 1838 participants, there is evidence of an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic endpoints such as primary vessel patency (high-quality evidence), binary restenosis rate (moderate-quality evidence), and target lesion revascularization (low-quality evidence) for up to 12 months. Conversely, there is no evidence of an advantage for DEBs in clinical endpoints such as amputation, death, or change in ABI, or change in Rutherford category during 12 months' follow-up. Well-designed randomized trials with long-term follow-up are needed to compare DEBs with uncoated balloon angioplasties adequately for both anatomic and clinical study endpoints before the widespread use of this expensive technology can be justified.

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Lower Limb Multilevel Treatment With Drug-Eluting Balloons:6-Month Results From the DEBELLUM Randomized Trial

Cited by 121 publications

References 20 publications

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

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

Tracheal Self-Expandable Metallic Stents: A Comparative Study of Three Different Stents in a Rabbit Model

Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs

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