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).
OBJECTIVE
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.
Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. Electronic address: Thomas.zeller@universitaets-herzzentrum.de.
Thomas
T
Zeller
coreLab Bad Krozingen GmbH, Bad Krozingen, Germany.
Ulrich
U
Beschorner
Department of Angiology, Medical University Graz, Graz, Austria.
Ernst
E
Pilger
Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.
Marc
M
Bosiers
Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.
Koen
K
Deloose
Department of Cardiovascular & Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
Patrick
P
Peeters
Department of Angiology, Park-Krankenhaus Leipzig, Leipzig, Germany.
Dierk
D
Scheinert
Vascular Center Berlin, Ev. Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany.
Karl-Ludwig
KL
Schulte
Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Aljoscha
A
Rastan
Department of Angiology, Medical University Graz, Graz, Austria.
Marianne
M
Brodmann
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D016638:Critical Illness; D004867:Equipment Design; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011859:Radiography; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency; D055815:Young Adult
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
below-the-knee; critical limb ischemia; drug-coated balloon; drug-eluting balloon; infrapopliteal; peripheral artery disease