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

• Published in: Journal of the American College of Cardiology 2014-10, Vol.64 (15), p.1568-1576
• Main Authors: Zeller, Thomas, Baumgartner, Iris, Scheinert, Dierk, Brodmann, Marianne, Bosiers, Marc, Micari, Antonio, Peeters, Patrick, Vermassen, Frank, Landini, Mario, Snead, David B, Kent, K Craig, Rocha-Singh, Krishna J
• Format: Article
• Language: English
• Subjects: 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
• ISSN: 1558-3597
• DOI: 10.1016/j.jacc.2014.06.1198

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).