title: Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial.
abstract: BACKGROUND
  Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.
  
  
  OBJECTIVE
  The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI).
  
  
  METHODS
  Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR.
  
  
  RESULTS
  Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080).
  
  
  CONCLUSIONS
  In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).
authors.affiliation: Department of Angiology, Universitäts Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.affiliation: Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital, Bern, Switzerland.
authors.forename: Iris
authors.initials: I
authors.lastname: Baumgartner
authors.affiliation: Center of Vascular Medicine, Park Hospital Leipzig, Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.affiliation: Department of Angiology, Medical University Graz, Graz, Austria.
authors.forename: Marianne
authors.initials: M
authors.lastname: Brodmann
authors.affiliation: Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.affiliation: Invasive Cardioangiology GVM Care and Research, Palermo, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Micari
authors.affiliation: Department of Cardiovascular & Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
authors.affiliation: Department of Vascular Surgery, Ghent University Hospital, Ghent, Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Vermassen
authors.affiliation: Medtronic Endovascular Therapies, Santa Rosa, California.
authors.forename: Mario
authors.initials: M
authors.lastname: Landini
authors.affiliation: Medtronic Endovascular Therapies, Santa Rosa, California.
authors.forename: David B
authors.initials: DB
authors.lastname: Snead
authors.affiliation: Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
authors.forename: K Craig
authors.initials: KC
authors.lastname: Kent
authors.affiliation: Prairie Heart Institute at St. John's Hospital, Springfield, Illinois. Electronic address: ksingh@prairieheart.com.
authors.forename: Krishna J
authors.initials: KJ
authors.lastname: Rocha-Singh
mesh_terms: D000368:Aged; D000792:Angiography; D000800:Angioplasty, Balloon / Q000379:methods*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D007866:Leg / Q000098:blood supply*; D008297:Male; D011150:Popliteal Artery; D011446:Prospective Studies; D016037:Single-Blind Method; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000379:methods*
keywords: critical limb ischemia; drug-eluting balloon; peripheral vascular disease