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Paclitaxel-Eluting Balloon vs. Standard Angioplasty to Reduce Recurrent Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: The DEBATE-ISR Study
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Paclitaxel-Eluting Balloon vs. Standard Angioplasty to Reduce Recurrent Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: The DEBATE-ISR Study
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Paclitaxel-Eluting Balloon vs. Standard Angioplasty to Reduce Recurrent Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: The DEBATE-ISR Study
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Journal Article
Paclitaxel-Eluting Balloon vs. Standard Angioplasty to Reduce Recurrent Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: The DEBATE-ISR Study
2014
Overview
Purpose
To test the ability of a drug-eluting balloon (DEB) to reduce recurrent
in-stent restenosis (ISR) in diabetic patients with femoropopliteal
stents.
Methods
A prospective all-comers study [Drug-Eluting Balloon in Peripheral
Intervention for In-Stent Restenosis (DEBATE-ISR); ClinicalTrials.gov identifier NCT01558531] of
symptomatic diabetic patients with femoropopliteal ISR undergoing treatment
with paclitaxel-eluting balloons was designed to compare their 12-month
recurrent restenosis rate with that of historical diabetic controls. From
January 2010 to December 2011, 44 consecutive diabetic patients (32 men;
mean age 74±11 years) were treated with DEBs and enrolled in the
study. The control group comprised 42 diabetic patients (23 men; mean age
76±7 years) treated with a conventional balloon for femoropopliteal
ISR from 2008 to 2009.
Results
No significant differences in terms of clinical, angiographic, or procedural
characteristics were observed between the study groups. Lesion length was
132±86 mm in the DEB group vs. 137±82 mm in the BA group.
Procedural success, defined as a residual stenosis <30% in the
restenotic segment (stent +5 mm at proximal and distal edges), was
obtained in all treated lesions. At 1-year follow-up, 6 patients died (3 in
each group), and 1 patient in the BA group underwent major amputation.
Recurrent restenosis, assessed by angiography (66%) or ultrasound
(34%), occurred in 8/41 (19.5%) patients in the DEB group vs.
28/39 (71.8%) in the BA group (p<0.001). Target lesion
revascularization for symptomatic recurrent restenosis was performed in 6/44
(13.6%) patients in the DEB vs.13/42 (31.0%) in the BA group
(p=0.045).
Conclusion
Using DEB for treating femoropopliteal ISR led to a significant reduction in
recurrent restenosis and repeat angioplasty at 1-year follow-up as compared
to historical controls.
Publisher
SAGE Publications,Allen Press Inc
Subject
/ Angioplasty, Balloon - adverse effects
/ Angioplasty, Balloon - instrumentation
/ Cardiovascular Agents - administration & dosage
/ Coated Materials, Biocompatible
/ Diabetes
/ Diabetic Angiopathies - diagnosis
/ Diabetic Angiopathies - mortality
/ Diabetic Angiopathies - therapy
/ Female
/ Femoral Artery - diagnostic imaging
/ Humans
/ Italy
/ Male
/ Paclitaxel - administration & dosage
/ Patients
/ Peripheral Arterial Disease - diagnosis
/ Peripheral Arterial Disease - mortality
/ Peripheral Arterial Disease - therapy
/ Popliteal Artery - diagnostic imaging
/ Stents
