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International Surgery and Ortho Conference
October 25-26, 2017 | Toronto, Canada
Case Rep Surg Invasive Proced 2017 | Volume 1 Issue 3
Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial
disease in diabetic patients: The Belgian diabetic IN.PACT trial
Debing E
1
, Aerden D
1
, Vanhulle A
1, 2
, Gallala S
1
and
Von Kemp K
1
1
Brussel University Hospital, Brussels, Belgium
2
St. Jan Brugge University Hospital, Ostend, Belgium
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 is the primary patency, mean diameter
restenosis and binary restenosis of the treated sites at 6months
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 better 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.
Speaker Biography
Dr. Laura Kerselaers is a vascular and endovascular surgeon who works at the vascular
department of University Hospital of Brussels (UZB), Belgium. Her clinical interest is in
critical limb ischemia, aortic repair, lower extremity occlusive disease, carotid disease
and varicose veins. Dr. Kerselaers obtained her medical degree at the University of
Louvain (KUL) and completed training in general and vascular surgery at ZOL Genk,
Imelda hospital Bonheiden and ETZ Tilburg. Later she completed fellowship training
in vascular and endovascular surgery at the University Hospital of Louvain (UZL) and
ZOL Genk. After completing this training, she joined the University Hospital of Brussels
(UZB) as a staff vascular and endovascular surgeon in 2016.
e:
erik.debing@uzbrussel.be