Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Zeller, T; Baumgartner, I; Scheinert, D; Brodmann, M; Bosiers, M; Micari, A; Peeters, P; Vermassen, F; Landini, M; Snead, DB; Kent, KC; Rocha-Singh, KJ; IN.PACT DEEP Trial Investigators.
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.
J Am Coll Cardiol. 2014; 64(15):1568-1576
Doi: 10.1016/j.jacc.2014.06.1198
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- Abstract:
- Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation. 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). 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. 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). 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). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Angiography -
- Angioplasty, Balloon - methods
- Arterial Occlusive Diseases - complications Arterial Occlusive Diseases - surgery
- Drug-Eluting Stents -
- Female -
- Follow-Up Studies -
- Humans -
- Ischemia - diagnosis Ischemia - etiology Ischemia - surgery
- Leg - blood supply
- Male -
- Popliteal Artery -
- Prospective Studies -
- Single-Blind Method -
- Treatment Outcome -
- Vascular Surgical Procedures - methods
- Find related publications in this database (Keywords)
- critical limb ischemia
- drug-eluting balloon
- peripheral vascular disease