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JACC Cardiovasc Interv. 2015 Oct;8(12):1614-22. doi: 10.1016/j.jcin.2015.07.011.

Paclitaxel-Coated Balloon in Infrapopliteal Arteries: 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries).

Author information

1
Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. Electronic address: Thomas.zeller@universitaets-herzzentrum.de.
2
coreLab Bad Krozingen GmbH, Bad Krozingen, Germany.
3
Department of Angiology, Medical University Graz, Graz, Austria.
4
Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.
5
Department of Cardiovascular & Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
6
Department of Angiology, Park-Krankenhaus Leipzig, Leipzig, Germany.
7
Vascular Center Berlin, Ev. Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany.
8
Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.

Abstract

OBJECTIVES:

The aim of BIOLUX P-II (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia.

BACKGROUND:

DEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce.

METHODS:

In this prospective, multicenter, randomized first-in-man study, 72 patients were randomized 1:1 to either a Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland) (n = 36) or Passeo-18 PTA (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory.

RESULTS:

The primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DEB group versus 8.3% in the PTA group (p = 0.239). The primary performance endpoint (patency loss at 6 months) was 17.1% in the DEB group versus 26.1% in the PTA group (p = 0.298), and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively.

CONCLUSIONS:

The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA.

KEYWORDS:

below-the-knee; critical limb ischemia; drug-coated balloon; drug-eluting balloon; infrapopliteal; peripheral artery disease

PMID:
26493253
DOI:
10.1016/j.jcin.2015.07.011
[Indexed for MEDLINE]
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