Journal article
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.
- Zeller T Department of Angiology, Universitäts Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany.
- Baumgartner I Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital, Bern, Switzerland.
- Scheinert D Center of Vascular Medicine, Park Hospital Leipzig, Leipzig, Germany.
- Brodmann M Department of Angiology, Medical University Graz, Graz, Austria.
- Bosiers M Department of Vascular Surgery, A.Z. Sint-Blasius, Dendermonde, Belgium.
- Micari A Invasive Cardioangiology GVM Care and Research, Palermo, Italy.
- Peeters P Department of Cardiovascular & Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium.
- Vermassen F Department of Vascular Surgery, Ghent University Hospital, Ghent, Belgium.
- Landini M Medtronic Endovascular Therapies, Santa Rosa, California.
- Snead DB Medtronic Endovascular Therapies, Santa Rosa, California.
- Kent KC Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
- Rocha-Singh KJ Prairie Heart Institute at St. John's Hospital, Springfield, Illinois. Electronic address: ksingh@prairieheart.com.
- 2014-10-11
Published in:
- Journal of the American College of Cardiology. - 2014
critical limb ischemia
drug-eluting balloon
peripheral vascular disease
Aged
Angiography
Angioplasty, Balloon
Arterial Occlusive Diseases
Drug-Eluting Stents
Female
Follow-Up Studies
Humans
Ischemia
Leg
Male
Popliteal Artery
Prospective Studies
Single-Blind Method
Treatment Outcome
Vascular Surgical Procedures
English
BACKGROUND
Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.
OBJECTIVES
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).
Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.
OBJECTIVES
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).
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jacc.2014.06.1198
- PMID 25301459
- Persistent URL
- https://sonar.ch/global/documents/294943
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