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THE JOURNAL OF CARDIOVASCULAR SURGERY

A Journal on Cardiac, Vascular and Thoracic Surgery


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ORIGINAL ARTICLE  VASCULAR SECTION


The Journal of Cardiovascular Surgery 2017 August;58(4):528-34

DOI: 10.23736/S0021-9509.16.09685-3

Copyright © 2016 EDIZIONI MINERVA MEDICA

language: English

Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients: the Belgian diabetic IN.PACT Trial

Erik DEBING 1 , Dimitri AERDEN 1, Alain VANHULLE 1, 2, Sarah GALLALA 1, Karl, von KEMP 1, on behalf of TRIAL Investigators 

1 Department of Vascular Surgery, Brussel University Hospital, Brussels, Belgium; 2 Department of Surgery, St Jan Brugge University Hospital, Oostende Campus, Ostend, Belgium


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BACKGROUND: Several trials have shown that drug coated balloon (DCB) angioplasty reduce the rates of restenosis in the femoropopliteal artery. This controlled, prospective, multicenter study was designed to demonstrate the efficacy of DCB to inhibit restenosis of the infrainguinal arteries in an exclusive diabetic population.
METHODS: Between 2012 and 2014, 106 diabetic patients with symptomatic peripheral arterial disease (PAD) were enrolled at 11 sites in Belgium, 54 treated with DCB angioplasty and 52 treated with plain old balloon angioplasty (POBA). The primary endpoint of the study are the primary patency, mean diameter restenosis and binary restenosis of the treated sites at 6 months without re-intervention in the interim.
RESULTS: The 6-month mean diameter restenosis was significantly lower in the DCB arm than in the POBA group (29±36% vs. 46±35%, P=0.032) and the binary (≥50% diameter stenosis) restenosis rate was signicantly lower in DCB patients compared with the POBA’s (27% vs. 49%, P=0.03). The primary patency was significantly better in the paclitaxel coated balloon group (73% vs. 51%, P=0.03). The 6-month adverse effects rates were 5.5% in the POBA and 5.7% in the DCB arm.
CONCLUSIONS: The treatment of diabetic PAD of the infra-inguinal arteries with the DCB provides a bettter primary patency rate compared with the plain old balloon angioplasty. The use of DCB did not increase the number of major adverse clinical events when compared with those seen with the use of the uncoated balloons.


KEY WORDS: Randomized controlled trial - Diabetes mellitus - Paclitaxel - Angioplasty

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Publication History

Issue published online: June 5, 2017
Article first published online: October 11, 2016
Manuscript accepted: October 6, 2016
Manuscript received: August 29, 2016

Cite this article as

Debing E, Aerden D, Vanhulle A, Gallala S, von Kemp K; TRIAL Investigators. Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients: the Belgian diabetic IN.PACT Trial. J Cardiovasc Surg 2017;58:528-34. DOI: 10.23736/S0021-9509.16.09685-3

TRIAL Investigators

Erik DEBING, Department of Vascular Surgery, Brussel University Hospital, Brussels, Belgium; Dimitri AERDEN, Department of Vascular Surgery, Brussel University Hospital, Brussels, Belgium; Alain VANHULLE, Department of Vascular Surgery, Brussel University Hospital, Brussels, Belgium; Department of Surgery, St Jan Brugge University Hospital, Oostende Campus, Ostend, Belgium; Sarah GALLALA, Department of Vascular Surgery, Brussel University Hospital, Brussels, Belgium; Karl von KEMP, Department of Vascular Surgery, Brussel University Hospital, Brussels, Belgium; Isabelle van HERZEELE, Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium; Nathalie MOREELS, Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium; Inge FOURNEAU, Department of Vascular Surgery, University Hospitals Leuven, Louvain, Belgium; Sabrina HOUTHOOFD, Department of Vascular Surgery, University Hospitals Leuven, Louvain, Belgium; Kim DAENENS, Department of Vascular Surgery, University Hospitals Leuven, Louvain, Belgium; Jeroen HENDRIKS, Department of Thoracic and Vascular Surgery, Universitair Ziekenhuis Antwerpen, Antwerp, Belgium; Patrick LAUWERS, Department of Thoracic and Vascular Surgery, Universitair Ziekenhuis Antwerpen, Antwerp, Belgium; Sven VERCAUTEREN, Department of Vascular Surgery, Antwerpen, Antwerp Hospital, Antwerp, Belgium; Dominik DEROOVER, Department of Vascular Surgery, Antwerpen, Antwerp Hospital, Antwerp, Belgium; Peter GOVERDE, Department of Vascular Surgery, Antwerpen, Antwerp Hospital, Antwerp, Belgium; Paul VERBRUGGEN, Department of Vascular Surgery, Antwerpen, Antwerp Hospital, Antwerp, Belgium; Tran van TU, Department of Vascular Surgery, Antwerpen, Antwerp Hospital, Antwerp, Belgium; Frank van THIELEN, Department of Vascular Surgery, Antwerpen, Antwerp Hospital, Antwerp, Belgium; Frank DEPUYDT, Department of Thoracic and Vascular Surgery, St Maria Ziekenhuis Halle, Hal, Belgium; Olivier LESCEU, Department of Thoracic and Vascular Surgery, St Maria Ziekenhuis Halle, Hal, Belgium; Jos VANDEKERKHOF, Department of Vascular Surgery, Hasselt Hospital, Hasselt, Belgium; Bob VERHELST, Department of Vascular Surgery, Saint-Luc University Clinic, Brussels, Belgium; Frank HAMMER, Department of Vascular Surgery, Saint-Luc University Clinic, Brussels, Belgium; Herman SCHROE, Department of Vascular Surgery, Oost Limburg Hospital, Genk, Belgium; Wouter LANSINK, Department of Vascular Surgery, Oost Limburg Hospital, Genk, Belgium; Geert LAUWERS, Department of Vascular Surgery, Oost Limburg Hospital, Genk, Belgium; Katelijne VANSLEMBROEK, Department of Vascular Surgery, Oost Limburg Hospital, Genk, Belgium; Michiel van BETSBRUGGE, Department of Vascular Surgery, Sint Augustinus Hospital, Antwerp, Belgium; Benoit THOMAS, Department of Vascular Surgery, Sint Augustinus Hospital, Antwerp, Belgium; De Roderik LEERSNIJDER, Department of Vascular Surgery, Sint Augustinus Hospital, Antwerp, Belgium; Frank VERMASSEN, Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium

Corresponding author e-mail

erik.debing@uzbrussel.be